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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94674

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

Open FDA event record

Event summary

Timeline bucket
April 16, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic 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

23 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 23

COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator

Z-2190-2024
Recall number
Z-2190-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
14

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178192, Serial Numbers: RTK624593S, RTK624594S, RTK624595S, RTK624596S, RTK624597S, RTK624599S, RTK624601S, RTK624602S, RTK624603S, RTK624604S, RTK624606S, RTK624607S; GTIN: 00763000711207, Serial Numbers: RTK624400S, RTK624405S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 2 of 23

COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator

Z-2191-2024
Recall number
Z-2191-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
8 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178147, Serial Numbers: RTH608902S, RTH608907S, RTH608911S, RTH608923S, RTH608935S, RTH608966S; GTIN: 00763000711191, Serial Numbers: RTH609509S, RTH609510S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 3 of 23

Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

Z-2192-2024
Recall number
Z-2192-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
14 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178130, Serial Numbers: RTG612496S, RTG612497S, RTG612498S, RTG612499S, RTG612502S, RTG612503S, RTG612504S, RTG612505S, RTG612509S, RTG612512S, RTG612513S, RTG612549S, RTG612553S, RTG612556S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 4 of 23

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator

Z-2193-2024
Recall number
Z-2193-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
11 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178109, Serial Numbers: RTD607545S, RTD607549S, RTD607551S; GTIN 00763000711177, Serial Numbers: RTD607363S, RTD607364S, RTD607367S, RTD607369S, RTD607370S, RTD607374S, RTD607404S, RTD607405S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 5 of 23

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator

Z-2194-2024
Recall number
Z-2194-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
58 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178093, Serial Number: RTC656756S; GTIN: 00763000178116, Serial Numbers: RTC656044S, RTC656047S, RTC656049S, RTC656061S, RTC656065S, RTC656070S, RTC656072S, RTC656099S, RTC656100S, RTC656102S, RTC656103S, RTC656104S, RTC656105S, RTC656106S, RTC656107S; GTIN: 00763000711160, Serial Numbers: RTC655925S, RTC655928S, RTC655930S, RTC655931S, RTC655932S, RTC655938S, RTC655945S, RTC655947S, RTC655950S, RTC655964S, RTC655971S, RTC656073S, RTC656074S, RTC656076S, RTC656077S, RTC656078S, RTC656080S, RTC656082S, RTC656087S, RTC656090S, RTC656093S, RTC656095S, RTC656096S, RTC656587S, RTC656589S, RTC656590S, RTC656592S, RTC656602S, RTC656603S, RTC656606S, RTC656607S, RTC656608S, RTC656609S, RTC656610S, RTC656615S, RTC656616S, RTC656619S, RTC656625S, RTC656626S, RTC656627S, RTC656628S, RTC656630S

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 6 of 23

CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator

Z-2195-2024
Recall number
Z-2195-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
26 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178253, Serial Number: RTS605244S; GTIN: 00763000178277, Serial Numbers: RTS604876S, RTS604877S, RTS604879S, RTS604885S; GTIN: 00763000711245, Serial Numbers: RTS604695S, RTS604698S, RTS604700S, RTS604703S, RTS604704S, RTS604714S, RTS604716S, RTS604717S, RTS604718S, RTS604721S, RTS604722S, RTS604723S, RTS604724S, RTS604726S, RTS604727S, RTS604728S, RTS604729S, RTS604730S, RTS604731S, RTS604732S, RTS604733S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 7 of 23

EVERA S VR, Model Number DVBC3D1, Implantable Cardioverter Defibrillator

Z-2196-2024
Recall number
Z-2196-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
1 unit

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000740559, Serial Number: BWM614493S

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 8 of 23

EVERA MRI S VR SureScan, Model Number DVMC3D4, Implantable Cardioverter Defibrillator

Z-2197-2024
Recall number
Z-2197-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
14 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000206208, Serial Number: PMZ646287S, PMZ646288S, PMZ646289S, PMZ646291S, PMZ646292S, PMZ646295S, PMZ646299S, PMZ646300S, PMZ646302S, PMZ646303S, PMZ646304S, PMZ646305S, PMZ646306S, PMZ646307S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 9 of 23

EVERA MRI S DR SureScan, Model Number DDMC3D1, Implantable Cardioverter Defibrillator

Z-2198-2024
Recall number
Z-2198-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
5 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000206192, Serial Number: CWC613698S, CWC613700S, CWC613713S, CWC613715S, CWC613717S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 10 of 23

EVERA MRI S DR SureScan, Model Number DDMC3D4, Implantable Cardioverter Defibrillator

Z-2199-2024
Recall number
Z-2199-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
40 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000206185, Serial Numbers: PHZ659606S, PHZ659607S, PHZ659610S, PHZ659611S, PHZ659612S, PHZ659666S, PHZ659667S, PHZ659693S, PHZ659694S, PHZ659696S, PHZ659707S, PHZ659729S, PHZ659745S, PHZ659749S, PHZ659750S, PHZ659753S, PHZ659754S, PHZ659755S, PHZ659803S, PHZ659804S, PHZ659805S, PHZ659806S, PHZ659807S, PHZ659884S, PHZ659886S, PHZ659890S, PHZ659892S, PHZ659907S, PHZ659908S, PHZ659996S, PHZ660020S; GTIN: 00763000612023, Serial Numbers: PHZ659058S, PHZ659064S, PHZ659065S, PHZ659066S, PHZ659069S, PHZ659075S, PHZ659077S, PHZ659078S; GTIN: 00763000740443, Serial Number: PHZ659565S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 11 of 23

PRIMO MRI DR SureScan, Model Number DDMD3D1, Implantable Cardioverter Defibrillator

Z-2200-2024
Recall number
Z-2200-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
2 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000611910, Serial Numbers: CWM605634S, CWM605635S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 12 of 23

MIRRO MRI DR SureScan, Model Number DDME3D1, Implantable Cardioverter Defibrillator

Z-2201-2024
Recall number
Z-2201-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
3 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000001568, Serial Numbers: CWS604689S, CWS604691S, CWS604694S

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 13 of 23

MIRRO MRI DR SureScan, Model Number DDME3D4, Implantable Cardioverter Defibrillator

Z-2202-2024
Recall number
Z-2202-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
26 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000611941, Serial Numbers: CWT611927S, CWT611929S, CWT611932S, CWT611933S, CWT611934S, CWT611935S, CWT611936S, CWT611937S, CWT611938S, CWT611939S, CWT611940S, CWT611941S, CWT611950S, CWT611951S, CWT612011S, CWT612012S, CWT612013S, CWT612014S, CWT612015S, CWT612016S, CWT612017S, CWT612022S, CWT612044S, CWT612045S; GTIN: 00763000740368, Serial Numbers: CWT611893S, CWT611908S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 14 of 23

PRIMO MRI VR SureScan, Model Number DVMD3D4, Implantable Cardioverter Defibrillator

Z-2203-2024
Recall number
Z-2203-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
46 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000611965, Serial Numbers: CWL619625S, CWL619626S, CWL619627S, CWL619631S, CWL619632S, CWL619633S, CWL619634S, CWL619635S, CWL619636S, CWL619637S, CWL619638S, CWL619639S, CWL619640S, CWL619641S, CWL619642S, CWL619645S, CWL619648S, CWL619649S, CWL619650S, CWL619652S, CWL619678S, CWL619683S, CWL619700S, CWL619733S, CWL619735S, CWL620413S, CWL620414S, CWL620415S, CWL620416S, CWL620417S, CWL620421S, CWL620422S, CWL620423S, CWL620424S, CWL620425S, CWL620426S, CWL620432S, CWL620477S, CWL620480S, CWL620483S, CWL620496S, CWL620500S, CWL620501S, CWL620502S, CWL620633S, CWL620652S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 15 of 23

MIRRO MRI VR SureScan, Model Number DVME3D1, Implantable Cardioverter Defibrillator

Z-2204-2024
Recall number
Z-2204-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
6 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000611972, Serial Numbers: CWP605601S, CWP605619S, CWP605620S, CWP605653S, CWP605654S, CWP605658S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 16 of 23

MIRRO MRI VR SureScan, Model Number DVME3D4, Implantable Cardioverter Defibrillator

Z-2205-2024
Recall number
Z-2205-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
13 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000611989, Serial Numbers: CWR621520S, CWR621521S, CWR621522S, CWR621523S, CWR621524S, CWR621525S, CWR621526S, CWR621527S, CWR621528S, CWR621529S, CWR621530S, CWR621531S, CWR621532S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 17 of 23

COBALT DR MRI SureScan, Model Number DDPB3D1, Implantable Cardioverter Defibrillator

Z-2206-2024
Recall number
Z-2206-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
9

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000711306, Serial Numbers: RSN604373S, RSN604374S, RSN604375S, RSN604376S, RSN604378S, RSN604380S, RSN604383S, RSN604385S, RSN604386S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 18 of 23

COBALT DR MRI SureScan, Model Number DDPB3D4, Implantable Cardioverter Defibrillator

Z-2207-2024
Recall number
Z-2207-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
36 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178406, Serial Numbers: RSO618526S, RSO618555S, RSO618559S; GTIN: 00763000711313, Serial Numbers: RSO618395S, RSO618396S, RSO618399S, RSO618400S, RSO618401S, RSO618402S, RSO618403S, RSO618405S, RSO618408S, RSO618409S, RSO618410S, RSO618412S, RSO618415S, RSO618416S, RSO618417S, RSO618419S, RSO618420S, RSO618421S, RSO618422S, RSO618439S, RSO618440S, RSO618443S, RSO618444S, RSO618580S, RSO618581S, RSO618582S, RSO618585S, RSO618586S, RSO618587S, RSO618588S, RSO618589S, RSO618590S, RSO618593S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 19 of 23

COBALT VR MRI SureScan, Model Number DVPB3D4, Implantable Cardioverter Defibrillator

Z-2208-2024
Recall number
Z-2208-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
4 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178512, Serial Numbers: RSF612135S, RSF612143S; GTIN: 00763000711375, Serial Numbers: RSF612097S, RSF612098S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 20 of 23

Cobalt XT DR MRI SureScan, Model Number DDPA2D1, Implantable Cardioverter Defibrillator

Z-2209-2024
Recall number
Z-2209-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
5 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178338, Serial Numbers: RSL607245S, RSL607881S, RSL607883S, RSL607884S, RSL607888S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 21 of 23

COBALT XT VR MRI SureScan, Model Number DVPA2D1, Implantable Cardioverter Defibrillator

Z-2210-2024
Recall number
Z-2210-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
8 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000711344, Serial Numbers: RSC604641S, RSC604642S, RSC604643S, RSC604644S, RSC604647S, RSC604653S, RSC604654S, RSC604655S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 22 of 23

CROME VR MRI SureScan, Model Number DVPC3D1, Implantable Cardioverter Defibrillator

Z-2211-2024
Recall number
Z-2211-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
9 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

GTIN: 00763000178543, Serial Numbers: RSG601442S, RSG601443S, RSG601445S, RSG601446S, RSG601449S, RSG601461S, RSG601467S, RSG601478S; GTIN: 00763000711382, Serial Number: RSG601428S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.

device · product 23 of 23

Product not distributed in the US. Implantable Cardioverter Defibrillators: a. VIVA QUAD XT CRT-D, Model Number DTBA2QQ. b. CLARIA MRI CRT-D SureScan, Model Number DTMA2D1. c. CLARIA MRI QUAD CRT-D SureScan, Model Number DTMA2QQ. d. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D1. e. AMPLIA MRI CRT-D SureScan, Model Number DTMB2D4. f. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2Q1. g. AMPLIA MRI QUAD CRT-D SureScan, Model Number DTMB2QQ. h. COMPIA MRI QUAD CRT-D SureScan, Model Number DTMC2QQ. i. EVERA MRI XT DR SureScan, Model Number DDMB2D4. j. VISIA AF MRI XT VR SureScan, Model Number DVFB2D1. k. VISIA AF MRI S VR SureScan, Model Number DVFC3D4. l. VISIA AF MRI XT VR SureScan, Model Number DVFB2D4.

Z-2212-2024
Recall number
Z-2212-2024
Initiated
April 16, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Inc.
Quantity
82 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
manufacturing defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Code information

a. GTIN: 00763000612269, Serial Numbers: BLG628370S, BLG628372S, BLG628373S. b. GTIN: 00763000206284, Serial Number: RPO606047S. c. GTIN: 00763000206222, Serial Numbers: RPB629895S, RPB629900S, RPB629902S, RPB629906S, RPB629909S, RPB629912S. d. GTIN: 00763000206307, Serial Number: RPQ610208S. e. GTIN: 00763000206291, Serial Numbers: RPK614721S, RPK614728S. f. GTIN: 00763000206253, Serial Numbers: RPP607499S, RPP607504S, RPP607517S, RPP607518S, RPP607522S, RPP607586S. g. GTIN: 00763000206246, Serial Numbers: RPG643295S, RPG643318S; GTIN 00763000611835, Serial Numbers: RPG643198S, RPG643199S, RPG643200S, RPG643203S, RPG643206S, RPG643209S, RPG643211S, RPG643213S, RPG643218S, RPG643219S, RPG643220S, RPG643221S, RPG643231S, RPG643251S. h. GTIN: 00763000206260, Serial Numbers: RPF648668S, RPF648672S, RPF648674S, RPF648675S, RPF648676S, RPF648677S, RPF648681S, RPF648684S, RPF648685S, RPF648686S, RPF648691S, RPF648693S, RPF648702S, RPF648758S, RPF648760S, RPF648761S, RPF648762S, RPF648763S, RPF648768S, RPF648769S, RPF648770S, RPF648771S, RPF648844S, RPF648846S, RPF648847S. i. GTIN: 00763000206147, Serial Numbers: PGZ663023S, PGZ663203S, PGZ663208S, PGZ663211S, PGZ663216S, PGZ663219S, PGZ663241S, PGZ663264S. j. GTIN: 00763000612191, Serial Numbers: CWH606546S, CWH606548S, CWH606551S, CWH606552S, CWH606553S. k. GTIN: 00763000206352, Serial Numbers: PMX622050S, PMX622052S, PMX622055S, PMX622056S, PMX622057S, PMX622059S. l. GTIN: 00763000206338, Serial Numbers: PLX622054S, PLX622056S, PLX622072S.

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.