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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84727

16 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 22, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Microvention, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

16 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 16

MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 100152H2HS-V; 100153H2HS-V; 100154H2HS-V; 100201H2HS-V; 100202H2HS-V; 100203H2HS-V; 100204H2HS-V; 100206H2HS-V, 100208H2HS-V, 100254H2HS-V, 100256H2HS-V, 100304H2HS-V; 100306H2HS-V; 100308H2HS-V; 100310H2HS-V; 100404H2HS-V; 100406H2HS-V, 100408H2HS-V, 100410H2HS-V, 100506H2HS-V, 100508H2HS-V; 100510H2HS-V, 100515H2HS-V, 100520H2HS-V, 100620H2HS-V, and MV-00208HHSA - Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1392-2020
Recall number
Z-1392-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
2,762 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100101H2HS-V - 1903135UR, 1903185UR, 1903225UR, and 1904035UR; 100102H2HS - V -1903135UR, 1903155UR, 1903155ZR, 1903185UR, 1903205UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR,1904155UR, 1904175UR, 1904175ZR, and 1904245UR; 100103H2HS-V - 1903015UR, 1903045UR, 1903065UR, 1903085UR, 1903135UR, 1903205UR 1904055UR, 1904085UR, 1904155UR, 1905085UR, 1905105UR, 1905135UR, and 1905155UR; 100104H2HS-V - 1903015UR, 1903135UR, 1903205UR, 1904085UR, 1904105UR, and 1904155UR; 100151H2HS-V - 1903085UR, 1903185UR, and 1904015UR; 100152H2HS-V - 1903135UR, 1903155UR, 1903205NR, 1903205UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065UR, 1905085UR, 1903045WR, 1903185WR, 1903205WR, 1904105WR, 1904175WR, 1904225WR, 1905065WR, and 1905175WR; 100153H2HS-V - 1903015UR, 1903065UR, 1903085UR, 1903185UR, 1904015UR, 1904015ZR, 1904105UR, 1904155UR, 1904245UR, 1904265UR, and 1904295UR; 100154H2HS-V - 1903135UR, 1903155UR, 1903205UR, 1903225UR, 1904015UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065NR, 1905065UR, 1905155NR, 1903185WR, 1903205WR, 1904105WR, 1904225WR, and 1905065WR; 100201H2HS-V - 1905105PR; 100202H2HS-V - 1903155UR, 1904105UR, 1903185WR, 1903205WR, 1904175WR, 1905065WR, 1905135WR, and 1905155WR; 100203H2HS-V - 1903015UR, 1904015ZR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1905025UR, 1905035NR, 1905035UR, 1905065UR, 1905085UR, 1905135NR, 1905155NR, 1903185WR, and 1905035WR; 100204H2HS-V - 1903015UR, 1903065UR, 1903085UR, 1904035UR, 1904155UR, 1904175UR, 1904175ZR, 1904225UR, 1904245UR, 1904245ZR, 1904265UR, 1904295UR, 1905025UR, 1905035NR, 1905035UR, 1905065UR, 1905085UR, 1905135NR, 1905155NR, 1904105WR, 1904175WR, 1905035WR, 1905065WR, 1905085WR, 1905135WR, and 1905155WR; 100206H2HS-V - 1903045UR, 1903065UR, 1903205UR, 1903225UR, 1904035UR, 1904055UR, 1904085UR, 1904105UR, 1904155UR, 1904175UR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065NR, 1905065UR, 1905085UR, 1905105UR, 1905135UR, 1903185WR, 1904225WR, 1905065WR, 1905105PR, and 1905135WR; 100208H2HS-V - 1903015UR, 1903045UR, 1903085UR, 1903205UR, 1903225UR, 1904015UR 1904035UR, 1904175ZR, 1904225UR, 1904245UR, 1904265UR, 1904295UR, 1905025UR, 1905035UR, 1905065UR, 1905085UR, 1905105UR, 1905135UR, and 1905085WR; 100254H2HS-V - 1904245NR, 1903185WR, and 1905065WR; 100256H2HS-V - 1905065WR; 100304H2HS-V - 1903065WR, 1903205WR, and 1904225WR; 100306H2HS-V - 1903065UR, 1903085UR, 1904155UR, 1904175UR, 1904225UR, 1905135NR, 1905035WR, 1905065WR, 1905105PR, 1905135WR, and 1905155WR; 100308H2HS-V - 1904015UR, 1904155UR, 1904175UR, 1904225UR, 1904265UR, 1904295UR, 1905025UR, 1905065NR, 1905085UR, 1905105UR, 1905135NR, 1905155NR, 1903065WR, 1903185WR, 1903205WR, 1905065WR, 1905105WR, 1905155WR, and 1905225WR; 100310H2HS-V - 1903135UR, 1903155UR, 1903185UR, 1903205UR, 1904015UR, 1904035UR, 1904055UR, 1904085UR, 1904155UR, 1904175UR, 1904175ZR, 1904225UR, 1904245UR, 1904295UR, 1905085WR, and 1905225WR; 100404H2HS-V - 1904175WR, 1904225WR, 1905035WR, 1905065WR, and 1905155WR; 100406H2HS-V - 1903205WR, 1904175WR, and 1905035WR; 100408H2HS-V - 1903085UR, 1903135UR, 1903155UR, 1903155ZR, 1903185UR, 1903225UR,1904015UR, 1904035UR, 1904055UR, 1904225UR, 1903155PR, 1903205WR, 1904105WR, 1904245WR, and 1905065WR; 100410H2HS-V - 1903115UR, 1903155UR, 1903205UR, 1904155UR, 1904175UR, 1904225UR, 1903045WR, and 1905085WR; 100506H2HS-V - 1905155WR; 100508H2HS-V - 1903205WR; 100510H2HS-V - 1903045WR, 1905085WR, and 1905225WR; 100515H2HS-V - 1903065WR, 1903225W6, 1904175WR, 1905085WR, and 1905225WR; 100520H2HS-V - 1904155WR, 1904175WR, 1905085WR, and 1905225WR; 100620H2HS-V - 1903045WR, 1904175WR, 1904225WR, 1905085WR; and MV-00208HHSA - 1904175YR, 1905065XR, and 1905085YR.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 2 of 16

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 100202HS3D-V, 100203HS3D-V, 100204HS3D-V, 100206HS3D-V, 100208HS3D-V, 100254HS3D-V, 100256HS3D-V, 100304HS3D-V, 100306HS3D-V, 100310HS3D-V, 100355HS3D-V, 100358HS3D-V, 100406HS3D-V, 100408HS3D-V, 100412HS3D-V, 100415HS3D-V, 100510HS3D-V, 100515HS3D-V; MV-00102HTDA, MV-00103HTDA, MV-00204HTDA,MV-00304HTDA, MV-00306HTDA, MV-00406HTDA, MV-00408HTDA, MV-00510HTDA, MV-01502HTDA, MV-01503HTDA, MV-01504HTDA; MV-02504HTDA, MV-02506HTDA, MV-03505HTDA, and MV-03508HTDA. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1393-2020
Recall number
Z-1393-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
1,725 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100102HS3D-V - 1903045WT, 1903065WT, 1903205WT, 1904015WT, 1904035WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905065WT, 1905085WT, 1905155WT, 1905175WT, and 1905205WT; 100103HS3D-V - 1903115TT, 1903015WT, 1903085WT, 1903135WT, 1904015WT, 1904035WT, 1904055WT, 1904105WT, 1904265WT, 1904295WT, 1905035WT, 1905105PT, 1905135WT, 1905155WT, and 1905225WT; 100152HS3D-V - 1903065NT, 1903045WT, 1903085WT, 1903205WT, 1903225WT, 1904015WT, 1904105WT, 1904175WT, 1904295WT, 1905025WT, 1905105WT, 1905135WT, 1905155WT, and 1905175WT; 100153HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903155WT, 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905135WT, and 1905205WT; 100154HS3D-V - 1903045WT, 1903085WT, 1903135WT, 1903185WT, 1903225WT, 1904015WT, 1904035WT, 1904085WT, 1904105WT, 1904155WT, 1904175WT, 1904225WT, 1905025WT, 1905135WT, 1905155PT, 1905155WT, 1905175WT, and 1905205WT; 100202HS3D-V - 1903015WT, 1903065WT, 1903185WT, 1903205WT, 1905105WT, and 1905205WT; 100203HS3D-V - 1904015WT, 1904035WT, 1904265WT, 1904295WT, 1905065WT, 1905085WT, 1905155WT, and 1905225PT; 100204HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904035WT, 1904055WT, 1904085WT, 1904245WT, 1904255WT, 1904295WT, 1905035WT, 1905065WT, and 1905085WT; 100206HS3D-V - 1904175WT, 1904225WT, 1904245WT, 1905105WT, 1905155PT, and 1905155WT; 100208HS3D-V - 1903085WT, 1903155WT, 1904035WT, 1905155PT, and 1905155WT; 100254HS3D-V - 1903015WT, 1903065WT, 1904015WT, 1904035WT, 1904055WT, 1904155WT, 1904225WT, 1904245WT, 1905035PT, 1905065WT; 100256HS3D-V - 1903015WT, 1903045WT, 1903065WT, 1903085WT, 1904015WC, 1904015WT, 1904035WT, 1904175WT, 1904245WT, 1904255WT, 1904265WT, 1904295WT, 1905035WH, 1905035WT, 1905155PT, and 1905225WT; 100304HS3D-V - 1903065WT, 1903115WT, 1903155WT, 1903205WT, 1904015WT, 1904055WT, 1904255WT, 1905105WT, 1905175WT, and 1905205WT; 100306HS3D-V - 1903085NT, 1903015WT, 1903085WT, 1903115WT, 1903135WT, 1903155WT, 1904015WT, 1904035WT, 1904055WT, 1904085WT, 1904225PT, 1904225WT, 1904245WT, 1904255WT, 1904265WT, 1905135WT, 1905175WT, and 1905205WT; 100310HS3D-V - 1903085WT and 1904035WT; 100355HS3D-V - 1903045WT, 1903085WT, 1904015WT, 1904225PT, 1904225WT, and 1905175WT; 100358HS3D-V - 1903065WT, 1904255WT, 1904265WT, 1904295WT, 1905035WT, 1905065WT, 1905085WT, 1905155WT, and 1905175WT; 100406HS3D-V - 1903015WT, 1903115WT, 1903205WT, 1904015WT, and 1905205WT; 100408HS3D-V - 1905205NT,1903085WT, 1903205WT, 1904015WT, 1904035WT, 1904055WT, 1904175WT, 1904225PT, 1904225WT, 1904255WT, 1904265WT, 1904295WT, 1905025WT, 1905105WT, 1905155WT, and 1905175WT; 100412HS3D-V - 1903135WT, 1904035WT, 1904175WT, and 1905105WT; 100415HS3D-V - 1903135WT, 1904035WT, 1905105WT, and 1905155WT; 100510HS3D-V - 1903065WT, 1904015WT, 1904035WT, 1904245WT, 1905105WT, and 1905155WT; 100515HS3D-V - 1903085NT, 1903015WT, 1903045WT, 1903085WT, 1903185WT, 1903205WT, 1904015WT, 1904035WT, 1904175WT, 1904265WT, 1904295WT, 1905025WT, 1905035WT, 1905085WT, 1905175WT; MV-00102HTDA - 1903015YT, 1903045YT, 1903155XT, 1904105YT, and 1904155XT; MV-00103HTDA - 1903045YT, 1903185YT, 1905065YT, and 1905085YT; MV-00204HTDA - 1904085YT and 1905065YT; MV-00304HTDA - 1905085YT; MV-00306HTDA - 1903015YT, 1903155XT, and 1903155YT; MV-00406HTDA - 1903015YT, 1904055YT, 1905065YT, and 1905085YT; MV-00408HTDA - 1903155YT, 1904015XT, 1904085YT, 1905035XT, 1905065YT, and 1905085YT; MV-00510HTDA - 1904085YT and 1905085YT; MV-01502HTDA - 1903015YT, 1904085YT, 1904105YT, 1905085YT, and 1905105YT; MV-01503HTDA - 1904055YT, 1904085YT, 1905085YT, 1905105XT, and 1905135YT; MV-01504HTDA - 1904085YT, 1904105YT, 1905085YT, 1905105XT, 1905105YT, 1905135YT, and 1905155YT; MV-02504HTDA - 1903155YT, 1904055YT, and 1905085YT; MV-02506HTDA - 1903155YT, 1905085YT, and 1905105YT; and MV-03505HTDA - 1903015YT, 1903155YT, 1904085YT, 1905085YT, and 1905105YT; and MV-03508HTDA - 1904055YT, 1904085YT, 1905085YT, and 1905105XT.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 3 of 16

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Regular, Sterile, Rx, REF numbers 100515HC-R-V, 100515HCSR-R-V, 100520HC-R-V, 100520HCSR-R-V, 100620HC-R-V, 100620HCSR-R-V, 100730HC-R-V, 100730HCSR-R-V, 100830HC-R-V, 100930HC-R-V, 100930HCSR-R-V, 101030HC-R-V, and 101030HCSR-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1394-2020
Recall number
Z-1394-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
486 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100515HC-R-V - 1903135RL, 1905135RL, 1903115LL, 1903135LL, 1903155LL, 1903225LL, 1904015LL, 1904175LL, 1905025LL, 1905035LL, 1905065LL, and 1905085LL; 100515HCSR-R-V - 1903225UL, 1904245UL, 1903045WL, 1903115WL, 1904015PL, 1904225WL, 1905065WL, and 1905225WL; 100520HC-R-V - 1905175LL, 1905205LL, 1905205VL; 100520HCSR-R-V - 1904245UL, 1904295UL, and 1903085WL; 100620HC-R-V - 1903115LL, 1905035LL, and 1905065LL; 100620HCSR-R-V - 1904245UL; 100730HC-R-V - 1905155LL, 1905175LL, and 1905225LL; 100730HCSR-R-V - 1904175PL, 1904225WL, and 1905035WL; 100830HC-R-V - 1905135RL, 1905135LL, and 1905175LL; 100930HC-R-V - 1903115LL; 100930HCSR-R-V - 1903085ZL, 1903115UL, 1903135UL, and 1904245UL; 101030HC-R-V - 1903135RL; and 101030HCSR-R-V - 1904245UL and 1903015RL.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 4 of 16

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Helical 10 Soft, Sterile, Rx, REF numbers 100206HCSR-S-V, 100208HC-S-V, 100208HCSR-S-V, 100306HCSR-S-V, 100308HCSR-S-V, 100310HC-S-V, 100310HCSR-S-V, 100410HC-S-V, 100410HCSR-S-V, Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1395-2020
Recall number
Z-1395-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
780 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100206HCSR-S-V - 1903225UH, 1904055UH, 1904085UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905225UH, 1903015WL, 1903205WL, 1904295WL, 1905035WL, and 1905175PL; 100208HC-S-V - 1904035RL, 1904155LL, 1905035LL, 1905065LL, and 1905065VL 100208HCSR-S-V - 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1903085RL, 1903015WL, and 1903065WL; 100306HCSR-S-V - 1903085WL and 1904015PL; 100308HCSR-S-V - 1904105UH, 1904155UH, 1903015PL, 1903015WL, 1903045WL, 1903085WL, 1903185WL, 1905135WL, and 1905175PL; 100310HC-S-V - 1903045VL, 1904155LL, 1905035LL, 1905065LL, and 1905155LL; 100310HCSR-S-V - 1904245UL, 1904265UL, 1903015WL, 1903085WL, and 1903185WL; 100410HC-S-V - 1904155LL, 1904175LL, 1905035LL, 1905065LL, and 1905135RL; and 100410HCSR-S-V - 1904105UL, 1903015WL, 1903085WL, and 1903185WL.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 5 of 16

MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Regular, Sterile, Rx, REF numbers 180520HC-R-V and 181230HC-R-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1396-2020
Recall number
Z-1396-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
9 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 180520HC-R-V - 1903135RE; and 181230HC-R-V - 1903085RE.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 6 of 16

MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Helical 18 Soft, Sterile, Rx, REF numbers 180204HC-S-V, 180208HC-S-V, 180308HC-S-V, 180410HC-S-V, and 180512HC-S-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Z-1397-2020
Recall number
Z-1397-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
169 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 180204HC-S-V - 1903185WE and 1905105WE; 180208HC-S-V - 1904175PE, 1904175WE, 1904225WE, 1904265WE, 1904295WE, 1905025WE, 1905065PE, 1905065WE, 1905085WE, 1905175WE, 1905225WE; 180308HC-S-V - 1904225WE, 1904265WE, 1905025WE, and 1905035WE; 180410HC-S-V - 1903185WE, 1904015PE, 1904265WE, 1904295WE, 1905085WE, and 1905175WE; and 180512HC-S-V - 1903185WE, 1904265WE, 1904295WE, 1905085PE, 1905085WE, 1905155PE, 1905155WE, and 1905225WE.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 7 of 16

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 100515CSSR-V, 100522CSSR-V, 100618CSSR-V, 100626CSSR-V, 100722CSSR-V, 100731CSSR-V, 100825CSSR-V, 100837CSSR-V, 100933CSSR-V, and 101036CSSR-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1398-2020
Recall number
Z-1398-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
3,442 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100202CSSR-V - 1903155ZC, 1903185UC, 1903225UC, 1904085UC, 1904225NC, 1905155ZC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1905065WC, 1905085WC, 1905105WC, 1905175WC, 1905205WC, and 1905225WC; 100254CSSR-V - 1904105UC, 1904155UC, 1904175UC, 1904225ZC, 1904245UC, 1905025UC, 1905035UC, 1905065UC, 1905105UC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1903015WC, 1904015WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, 1905175WC, and 1905225WC; 100306CSSR-V - 1903045UC, 1903065UC, 1903085UC, 1903115UC, 1903135UC, 1903155ZC, 1903185UC, 1903205UC, 1903225UC, 1904035RC, 1904105UC, 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1904265UC, 1904295UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905105ZC, 1905135UC, 1905155UC, 1905175UC, 1905205UC, 1905205ZC, 1905225UC, 1903015WC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904055WC, 1904085WC, 1904225PC, 1904225WC, 1904245WC, 1904245WH, 1904245WT, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905105WC, 1905155PC, and 1905205WC; 100408CSSR-V - 1903065UC, 1904015UC, 1904035RC, 1904035UC, 1904055UC, 1904055ZC, 1904085UC, 1903015WC, 1904015WC, 1904035WC, 1904155WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, and 1905175WC; 100412CSSR-V - 1903185UC, 1903205UC, 1903225UC, 1905085UC, 1905105ZC, 1905135UC, 1905225UC, 1903045WC, 1903085WC, 1903205WC, 1903225WC, 1904175PC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, 1905205WC, and 1905225WC; 100515CSSR-V - 1903185UC, 1903205UC, 1904035RC, 1904155UC, 1904175UC, 1904225UC, 1904225ZC, 1904245UC, 1904265UC, 1905025UC, 1905035UC, 1905065UC, 1905085UC, 1905105UC, 1905135UC, 1905155UC, 1905205UC, 1905225UC, 1905225ZC, 1903015WC, 1903065WC, 1903085WC, 1903185WC, 1903205WC, 1904015WC, 1904035WC, 1904175WC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100522CSSR-V - 1904155UC, 1904175UC, 1904225UC, 1904245UC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904055WC, 1904175WC, 1904245WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905155WC, 1905175WC, and 1905205WC; 100618CSSR-V - 1903205LC, 1905155LC, 1905205LC, 1905205VC, 1903045WC, 1903085WC, 1903185WC, 1904175WC, 1904225WC, 1904245WC, 1905025WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905225WC; 100626CSSR-V - 1903015LC, 1903045WC, 1903065WC, 1903205WC, 1904015WC, 1904295WC, 1905065WC, 1905085WC, and 1905205WC; 100722CSSR-V - 1903015WC, 1903065WC, 1903185WC, 1904015WC, 1904175WC, 1904265WC, 1904295WC, 1905035WC, 1905065WC, 1905085WC, 1905155WC, and 1905175WC; 100731CSSR-V - 1903015WC, 1903045WC, 1903065WC, 1905085WC, 1905105WC, 1905155WC, and 1905205PC; 100825CSSR-V - 1903015WC, 1903045WC, 1904015WC, 1904105WC, 1904175PC, 1904225WC, 1904245WC, 1904265WC, 1904295WC, 1905085WC, 1905155PC, and 1905175WC; 100837CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1904015WC, 1905105WC, 1905135WC, and 1905205WC; 100933CSSR-V - 1905135RC, 1903015WC, 1903045WC, 1903065WC, 1903085WC, 1904015WC, 1904265WC, 1905105WC, 1905175WC, and 1905225WC; and 101036CSSR-V - 1903015WC, 1903065WC, 1903085WC, 1903115WC, 1903205WC, 1905155WC, and 1905225WC.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 8 of 16

MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451CS-V, 181652CS-V, 181859CS-V, 182065CS-V, 182263CS-V, and 182468CS-V; Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1399-2020
Recall number
Z-1399-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
403 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 180619CS-V - 1903065W1, 1904015P1, 1904225W1, 1904295W1, 1905085P1, 1905085W1, 1905175W1, and 1905205W1; 180723CS-V - 1903085W1, 1903185W1, 1904015P1, 1904175P1, 1904295W1, 1905085W1, and 1905175W1; 180827CS-V - 1903205W1, 1904015P1, 1905155W1, and 1905205W1; 180931CS-V - 1904225R1, 1903205W1, 1905175W1, and 1905225W1; 181036CS-V - 1904035R1, 1903085W1, 1903185W1, 1904225W1, 1904265W1, 1905035W1, 1905065W1, 1905175W1, and 1905205W1; 181139CS-V - 1903015L1, 1903015W1, 1903085P1, 1903085W1, 1903185W1, 1904015P1, 1904245P1, and 1904245W1; 181243CS-V - 1903015L1, 1903015W1, 1903065W1, 1903185W1, 1904015P1, 1904175P1, 1904225W1, 1904265W1, 1904295W1, 1905155W1, 1905175W1, and 1905225W1; 181347CS-V - 1903085V1, 1903135R1, 1904035R1, 1903015W1, 1903085W1, 1903205P1, 1903205W1, and 1904225W1; 181451CS-V - 1903085W1, 1903225W1, 1904015P1, 1904175P1, 1904225W1, 1904295W1, 1905105W1, and 1905135W1; 181652CS-V - 1905135R1, 1903015W1, 1903045W1, 1903085W1, 1903205W1, 1903225W1, 1904105W1, 1905105W1, and 1905225W1; 181859CS-V - 1903155P1, 1903155W1, 1903185H1, and 1905105W1; 182065CS-V - 1903045L1, 1904085Q1, 1903155W1, 1903185H1, and 1903205H1; 182263CS-V - 1904035R1; and 182468CS-V - 1903015L1, 1903135R1, 1904055R1, 1905205R1, 1904295H1, 1905025G1, 1905025H1, 1905105H1, 1905105W1, 1905135H1, and 1905205H1.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 9 of 16

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Complex 10, Sterile, Rx, REF numbers 100204CC-V, 100307CC-V, 100410CC-V, 100512CC-V, 100615CC-V, 100718CC-V, 100820CC-V, 100924CC-V, and 101026CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1400-2020
Recall number
Z-1400-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
409 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100204CC-V -1905085LX, 1905175LX, 1905205LX, 1903185WX, 1903205WX, 1904225WX, 1904245WX, 1904265WX, and 1904295WX; 100307CC-V - 1903205WX, 1904015WX, 1904225WX, 1904245WX, 1904265WX, and 1905225WX; 100410CC-V - 1904015WX, 1904175PX, 1904175WX, 1904225WX, 1904245WX, 1904265WX, 1905025WX, 1905065WX, 1905155WX, 1905205WX, and 1904035QX; 100512CC-V - 1903115LX, 1905205LX, 1903045WX, 1903205PX, 1903205WX, 1904225WX, 1905175WX, 1905205WX, 1904225RX, and 1905135RX; 100615CC-V - 1903085WX, 1903205WX, 1904225WX, 1904265WX, 1905105WX, 1905175WX, and 1905225PX; 100718CC-V - 1903115LX, 1905175LX, 1905205LX, 1903185WX, 1903205WX, 1904225WX, 1904265WX, 1905105WX, and 1905175WX; 100820CC-V - 1905175LX, 1904175WX, 1905025WX, 1905065PX, and 1905135RX; 100924CC-V - 1905175LX, 1904175WX, 1905065PX, 1905155WX, and 1904225RX; and 101026CC-V - 1905105LX, 1905175LX, 1905205LX, 1904175WX, 1904225WX, and 1905065PX.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 10 of 16

MicroVention Terumo Microplex 18, Platinum Coil System, Endovascular Embolization Coil, Complex 18, Sterile, Rx, REF numbers 180512CC-V, 180820CC-V, 181026CC-V, 181434CC-V, and 182050CC-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1401-2020
Recall number
Z-1401-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 180512CC-V - 1905205W3; 180820CC-V - 1903115L3; 181026CC-V - 1903115L3; 181434CC-V - 1903115L3, 1905155W3, and 1905205R3; and 182050CC-V - 1905205W3, 1903115L3, 1903115L3, 1903115L3, 1905155W3, and 1905205R3.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 11 of 16

MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V, 100510HFRM-V, 100515HFRM-V, 100519HFRM-V, 100612HFRM-V, 100619HFRM-V, 100623HFRM-V, 100715HFRM-V, 100728HFRM-V, 100817HFRM-V, 100833HFRM-V, 100931HFRM-V; 101036HFRM-V, MV-00408HHFA, MV-00510HHFA, MV-00515HHFA, and MV-00619HHFA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature.

Z-1402-2020
Recall number
Z-1402-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
991 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100306HFRM-V - 1903135WF, 1903155WF, 1903015UF, 1903065UF, 1903065ZF, 1903085UF, 1903135UF, 1903155NF, 1903205UF, 1904015UF, 1904035UF, 1904155UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905175UF; 100405HFRM-V - 1903015WF, 1903085WF, 1904225PF, and 1905155WF; 100408HFRM-V - 1903015WF, 1903065WF, 1903085WF, 1903155WF, 1903225WF, 1904225PF, 1905155WF, 1903015UF, 1903135UF, 1903205UF, 1903225UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905025UF, 1905085UF, 1905135UF, and 1905155UF; 100410HFRM-V - 1903085WF and 1904055WF; 100412HFRM-V - 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904155UF, 1904175UF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905155UF, 1905205UF, and 1905225UF; 100415HFRM-V - 1904105WF, 1904225PF, and 1905035WF; 100510HFRM-V - 1903015WF, 1903185WF, 1904175WF, 1905155WF, and 1905205RF; 100515HFRM-V - 1903015WF, 1903085WF, 1903185WF, 1904105WF, 1904175WF, 1904225PF, 1904225WF, 1904245WF, 1905085WF, 1903085UF, 1903135UF, 1903155UF, 1903205UF, 1903225UF, 1904015UF, 1904035UF, 1904055UF, 1904175UF, 1904175ZF, 1904225UF, 1904245UF, 1904265UF, 1904295UF, 1905085UF, 1905105UF, 1905135UF, 1905155UF, and 1905225UF; 100519HFRM-V - 1905155UF; 100612HFRM-V - 1903185WF, 1903225WF, and 1905205WF; 100619HFRM-V - 1903065WF, 1903185WF, 1903225WF, 1905155WF, 1903085UF, 1903155UF, 1903225UF, 1904155UF, 1904175UF, 1904225UF, and 1904245UF; 100623HFRM-V - 1903115UF; 100715HFRM-V - 1903045WF, 1903115WF, 1903135WF, 1903185WF, and 1903155QF; 100728HFRM-V - 1903015WF, 1903085WF, 1905155WF, and 1904225UF; 100817HFRM-V - 1903045WF, 1903135WF, and 1905155WF; 100833HFRM-V - 1903015WF, 1903045WF, 1903085WF, 1905155WF, 1905205WF, 1904055UF, and 1904225UF; 100931HFRM-V - 1903085WF, 1903185WF, 1904225PF, 1905155WF, 1903205UF, 1904015UF, 1904035UF, 1904265UF, and 1904295UF; 101036HFRM-V - 1903015WF, 1904225PF, 1905155WF, and 1904175UF; MV-00408HHFA - 1905175YF; MV-00510HHFA - 1905105YF; MV-00515HHFA - 1905175YF and 1905205YF; and MV-00619HHFA - 1905035YF and 1905175YF.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 12 of 16

MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, and MV-81036HHFA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1403-2020
Recall number
Z-1403-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
32 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 180723HFRM-V - 1904175P7 and 1904175W7; 180931HFRM-V - 1904225P7 and 1904225W7; 181644HFRM-V - 1905025W7 and 1905155W7; MV-80619HHFA - 1904175X7, 1904175Y7,1905065X7, and 1905085Y7; MV-80827HHFA - 1904175X7, 1904225Y7, and 1905065X7; MV-80931HHFA - 1905065X7; and MV-81036HHFA - 1904175Y7.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 13 of 16

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Compass 10, Sterile, Rx, REF numbers 100203CMSR-V, 100408CMSR-V, 100412CMSR-V, 100510CMSR-V, 100516CMSR-V, 100612CMSR-V, 100618CMSR-V, and 100721CMSR-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1404-2020
Recall number
Z-1404-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
85 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100203CMSR-V - 1903085WP; 100408CMSR-V - 1903085WP and 1904015PP; 100412CMSR-V - 1904225RP, 1905205QP, and 1904035PP; 100510CMSR-V - 1905205QP and 1904085WP; 100516CMSR-V - 1903135WP and 1905155WP; 100612CMSR-V - 1903225WP; 100618CMSR-V - 1903135QP and 1904085WP; and 100721CMSR-V - 1903085RP.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 14 of 16

MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, 100206HFRM-V, 100208HFRM-V, 100254HFRM-V, 100256HFRM-V, 100308HFRM-V, MV-00202HHTA, MV-00203HHTA, MV-00204HHTA, MV-00206HHTA, MV-00208HHTA, MV-00304HHTA, MV-00306HHTA, MV-00308HHTA, MV-00310HHTA, MV-00408HHTA, MV-00412HHTA, MV-00510HHTA, MV-00515HHTA, MV-00612HHTA, MV-00619HHTA, MV-00715HHTA, MV-00728HHTA, MV-00817HHTA, MV-00833HHTA, MV-01502HHTA, MV-01503HHTA, MV-01504HHTA, MV-02504HHTA, MV-02506HHTA, and MV-02508HHTA. Product Usage: The HES is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1405-2020
Recall number
Z-1405-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
847 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100102HFRM-V - 1903045W6 and 1903135W6; 100152HFRM-V - 1903085W6, 1903185P6, and 1903185W6; 100153HFRM-V - 1903135W6; 100154HFRM-V - 1903015W6, 1903205W6, 1903225W6, 1904225P6, and 1904225W6; 100202HFRM-V - 1903065W6, 1903085W6, and 1903135W6; 100206HFRM-V - 1903065W6 and 1903085W6; 100208HFRM-V - 1903065W6; 100254HFRM-V - 1903045W6, 1903085W6, and 1903115W6; 100256HFRM-V - 1903045W6 and 1903225W6; 100308HFRM-V - 1903115W6, 1903155W6, and 1903205W6; MV-00202HHTA - 1903065Y6, 1903205Y6, and 1903225Y6; MV-00203HHTA - 1903085Y6, 1903225Y6, 1904155Y6, 1905085X6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00204HHTA - 1903085Y6, 1904155X6, 1904155Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; MV-00206HHTA - 1904015Y6, 1904155X6, 1905025Y6, 1905035Y6, 1905085Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00208HHTA - 1905135Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00304HHTA - 1903065Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1905025Y6, 1905065Y6, and 1905085Y6; MV-00306HHTA - 1903135Y6, 1903205Y6, 1903225Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, and 1905135Y6; MV-00308HHTA - 1905085Y6, 1905205Y6, and 1905225Y6; MV-00310HHTA - 1905025Y6, 1905035Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00408HHTA - 1903225X6, 1904035Y6, 1905025Y6, and 1905035Y6; MV-00412HHTA - 1903115Y6, 1903135Y6, 1903205Y6, 1904035Y6, 1904055Y6, 1904085Y6, 1904105Y6, 1904225Y6, 1905025Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175Y6, and 1905205Y6; MV-00510HHTA - 1903225Y6, 1904035Y6, 1904055Y6, 1905085Y6, 1905105Y6, 1905175Y6, and 1905225Y6; MV-00515HHTA - 1903225X6, 1904035Y6, 1905025Y6, 1905035Y6, 1905085Y6, 1905105Y6, 1905135Y6, 1905175X6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00612HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903225X6, 1904055Y6, 1905025Y6, 1905035Y6, and 1905085Y6; MV-00619HHTA - 1903085Y6, 1903115Y6, 1903225Y6, 1904055Y6, 1905035Y6, 1905065Y6, 1905085Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00715HHTA - 1905065Y6, 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, 1905225X6, and 1905225Y6; MV-00728HHTA - 1905105Y6, 1905135Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-00817HHTA - 1905105Y6, 1905175Y6, and 1905205X6; MV-00833HHTA - 1903085Y6, 1903205Y6, 1905035Y6, 1905085Y6, 1905135Y6, and 1905205Y6; MV-01502HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905105Y6, 1905175Y6, and 1905205Y6; MV-01503HHTA - 1903085Y6, 1903115Y6, 1903135Y6, 1903205Y6, 1903225X6, 1903225Y6, 1904035Y6, and 1905035Y6; MV-01504HHTA - 1905035Y6, 1905065Y6, and 1905085Y6; MV-02504HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905175Y6, 1905205Y6, and 1905225Y6; MV-02506HHTA - 1903085Y6, 1903205Y6, 1905025Y6, 1905065Y6, 1905105Y6, 1905135Y6, 1905205Y6, and 1905225Y6; and MV-02508HHTA - 1905085Y6, 1905105Y6, 1905135Y6, 1905155Y6, 1905205Y6, and 1905225Y6.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 15 of 16

MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC030610-V, VFC030615-V, VFC061020-V, VFC061030-V, VFC101530-V, VFC101540-V, VFC152040-V, and VFC152060-V. Product Usage: . The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1406-2020
Recall number
Z-1406-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
666 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: MV-00306VFC - 1904105NZ and 1905085NZ; MV-00310VFC - 1903045TZ, 1904035TZ, 1904085NZ, AND 1905065NZ; MV-00315VFC - 1903045TZ, 1903155NZ, and 1904055YV; MV-00630VFC - 1904085FV and 1905085FV; VFC010303-V - 1903065WV, 1904015WV, 1904105WV, 1904155WV, 1904175WV, 1904225WV, 1904245WV, 1904265WV, 1905065WV, 1905105WV, 1905155WV, and 1905175WV; VFC030606-V - 1903045WV, 1903065WV, 1903085PV, 1903205WV, 1904015WV, 1904035WV, 1904055WV, 1904105WV, 1904155PV, 1904175UV, 1904175WV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, and 1905175WV; VFC030610-V - 1903015WV, 1903065WV, 1904015WV, 1904035WV, 1904055WV, 1904155WV, 1904175UV, 1904175WV, 1904225UV, 1904225WV, 1904245UV, 1904245WV, 1904265WV, 1905065WV, 1905085WV, 1905105WV, 1905135WV, 1905155PV, 1905175WV, and 1905225WV; VFC030615-V - 1903015WV, 1903045WV, 1903065PV, 1903065WV, 1903225UV, 1903225ZV, 1904015WV, 1904055WV, 1904085WV, 1904245WV, 1904265WV, 1905025WV, 1905035WV, 1905085PV, 1905085WV, and 1905175WV; VFC061020-V - 1903045WV, 1903065WV, 1903205WV, 1904225WV, 1904265WV, 1905025WV, 1905065WV, 1905085WV 1905175WV, and 1905225WV; VFC061030-V - 1903065WV, 1904015PV, 1904015WV, 1904055WV, 1904225WV, 1904245WV, 1904265WV, 1905035WV, 1905065PV, and 1903115RV; VFC101530-V - 1903135WV, 1904265WV, 1905025WV, 1905105WV, 1905175WV, and 1905205WV; VFC101540-V - 1903045WV, 1903185WV, 1904265WV, 1905025WV, 1905035WV, and 1905225WV; VFC152040-V - 1903135RV; and VFC152060-V - 1903085RV, 1904265RV, and 1905135RV.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.

device · product 16 of 16

MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft Helical, Sterile, Rx, REF numbers 100101HS-V, 100102HS-V, 100103HS-V, 100104HS-V, 100151HS-V, 100152HS-V, 100153HS-V, 100154HS-V, 100201HS-V, 100202HS-V, 100203HS-V, 100204HS-V, 100206HS-V, 100254HS-V, 100256HS-V, 100304HS-V, 100306HS-V, 100308HS-V, 100406HS-V, 100408HS-V, and 100508HS-V. Product Usage: The MCS is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolizations in the peripheral vasculature. The firm name on the label is MicroVention, Inc., Tustin, CA.

Z-1407-2020
Recall number
Z-1407-2020
Initiated
November 22, 2019
Classification
Class II
Status
Terminated
Recalling firm
Microvention, Inc.
Quantity
5,777 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The devices may be missing the implant coil.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The devices may be missing the implant coil.

Code information

Catalog/lot numbers: 100101HS-V - 1903045UH, 1903065UH, 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1905025UH, 1905085UH, 1905105ZH, 1905135UH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1903135WH, 1904175WH, 1905085WH, 1905105PH, and 1905135WH; 100102HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1903225ZH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905205ZH, 1905225UH, 1905225ZH, 1904035WH, and 1905155WH; 100103HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1904105UH, 1904155UH, 1904175UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, and 1905085WH; 100104HS-V - 1903115UH, 1903135UH, 1903225UH, 1904085UH, 1904105UH, 1904155UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1904175WH, 1904225WH, and 1905155WH; 100151HS-V - 1905025UH, 1903135TH, 1903085WH, 1903205WH, 1904015WH, 1904265WH, 1904295WH, 1905085WH, 1905155WH, and 1905225PH; 100152HS-V - 1903155UH, 1903185UH, 1903205UH, 1904085UH, 1904105UH, 1904155UH, 1904225UH, 1904245UH, 1905025UH, 1905025ZH, 1905035UH, 1905035ZH, 1905065UH. 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205ZH, 1903065NH, 1904175TH, 1904225NH, 1905065NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904085WH, 1904155WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155WH, and 1905225WH; 100153HS-V - 1903225UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1905225UH, 1905225ZH, 1903015NH, 1903065WH, 1903085WH, 1903205WH, 1904015WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225PH, 1904225WH, 1904245WH, 1904265WH, 1905025WH, 1905035PH, 1905065WH, 1905085WH, 1905155WH, 1905205PH, 1905225PH, and 1905225WH. 100154HS-V - 1903155UH, 1903185UH, 1903205UH, 1903225UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905155ZH, 1905175UH, 1905205UH, 1905225UH, 1903115TH, 1903015WH, 1903045WH, 1903065WH, 1904035WH, 1904055WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035PH, 1905035WH, 1905065WH, 1905085WH, 1905155PH, 1905155WH, 1905175WH, and 1905205WH; 100201HS-V - 1903135UH 100202HS-V - 1904085UH, 1904105UH, 1904175UH, 1904245UH, 1904225NH, 1905065NH, 1905205NH, 1903085WH, 1904015WH, 1904055WH, 1904175WH, 1904245WH, 1904265WH, 1904295WH, 1905085WH, 1905225PH, and 1905225WH; 100203HS-V - 1903155UH, 1903185UH, 1903225UH, 1904225NH, 1905135NH, 1903015WH, 1903065WH, 1904035WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905035WH, 1905155WH, and 1905225WH; 100204HS-V - 1904085UH, 1904105UH, 1904225UH, 1904245UH, 1905065UH, 1905085UH, 1905105UH, 1905135UH, 1905135ZH, 1905155UH, 1905175UH, 1905205UH, 1903045WH, 1903065WH, 1904015WH, 1904035WH, 1904155WH, 1904175WH, 1904225PH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035WH, 1905085WH, 1905155WH, and 1905225WH; 100206HS-V - 1904085UH, 1904105UH, 1904155UH, 1904175UH, 1904265UH, 1905065UH, 1905085UH, 1905105UH, 1905105ZH, 1905135UH, 1905155UH, 1905175UH, 1905205UH 1905205ZH, 1905225UH, 1903065WH, 1903085WH, 1903185WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, 1905065WH, 1905155WH, 1905175WH, and 1905225WH; 100254HS-V - 1903205WH, 1904015WH, 1904225WH, 1904265WH, 1904295WH, 1905025WH, 1905085WH, and 1905225PH; 100256HS-V - 1903065WH, 1903185WH, 1904015WH, and 1905155WH; 100304HS-V - 1903085NH, 1903135TH, 1904035TH, 1903065WH, 1905035PH, and 1905065WH; 100306HS-V - 1903115UH, 1903135UH, 1903155UH, 1903185UH, 1904085UH, 1903065WH, 1904035WH, 1904055WH, 1904155WH, 1904175WH, 1904225WH, 1904245WH, 1905035PH, 1905065WH, 1905205PH, and 1905225PH; 100308HS-V - 1903185UH, 1903225UH, 1905135UH, 1905175UH, 1905205UH, 1903085NH, 1903015WH, 1903065WH, 1903185WH, 1904015WH, 1904035WH, 1904055WH, 1904175WH, 1904225WH, 1904245WH, 1904265WH, 1904295WH, 1905025WH, 1905035PH, 1905035WH, and 1905065WH; 100406HS-V - 1903085WH, 1903185WH, 1904035WH, 1904225WH, and 1905205WH; 100408HS-V - 1905085UH, 1905105UH, 1905135UH, 1905155UH, 1903115TH, 1903015WH, 1903065WH, 1904265WH, 1904295WH, 1905085WH, 1905135WH, 1905155WH, and 1905205PH; 100508HS-V - 1903225TH, 1905205NH, 1903015WH, 1903085WH, 1903135WH, 1903185WH, 1904265WH, 1905105WH, and 1905205WH.

Distribution pattern

All distribution was OUS. The countries receiving affected product are: Albania, Austria, Belarus, Belgium, Brazil, Bulgaria, China, Cyprus, Czech Republic, Denmark, Egypt, Finalnd, France, Georgia, Germany, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Malta, Morocco, Netherlands, Norway, Poland, Portugal, Republic of Serbia, Romania, Russian Federation, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Turkey, Ukraine, United Arab Emirates, and United Kingdom.