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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77810

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

Open FDA event record

Event summary

Timeline bucket
June 29, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sorin Group USA, 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

SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA

Z-2783-2017
Recall number
Z-2783-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
50 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1625200040, 1635400048, 1704700039, 1706700087, 1711400055, 1717200038

Distribution pattern

Nationwide

device · product 2 of 16

SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA

Z-2784-2017
Recall number
Z-2784-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
98 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1620000123, 1622800056, 1623500052m 1627700083, 1631200074, 1700300040, 1701000065, 1703700061, 1706500063, 1708000068, 1717000057

Distribution pattern

Nationwide

device · product 3 of 16

SORIN GROUP, SMART PERFUSION PACK, SMA PRIMO2X OPTI PACK, REF 088512900, STERILE EO, Rx Only, 1 EA

Z-2785-2017
Recall number
Z-2785-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
524 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1620700048, 1621600063, 1623700039, 1624500038, 1625900047, 1626500084, 1627800066, 1628500062, 1630000040, 1630500055, 1631400035, 1633300052, 1635400049, 1700600038, 1702500069, 1704500039, 1706600107, 1707400082, 1708600072, 1710800102, 1711700034, 1713600045, 1715000038, 1717000046

Distribution pattern

Nationwide

device · product 4 of 16

SORIN GROUP, SMART PERFUSION PACK, INSPIRE 6FS, REF 044008204, STERILE EO, Rx Only, 1 EA

Z-2786-2017
Recall number
Z-2786-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
52 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1626400126, 1628100032, 1631900034, 1632800034, 1703300043, 1707400063, 1708000042, 1710000040, 1716500018

Distribution pattern

Nationwide

device · product 5 of 16

SORIN GROUP, SMART PERFUSION PACK, SMART VENOUS VACUUM, REF 084118102, STERILE EO, Rx Only, 1 EA

Z-2787-2017
Recall number
Z-2787-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
632 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot numbers: 1620200038, 1621700037, 1622800048, 1623100036, 1623700036, 1625700047, 1627900048, 1630500054, 1630600077, 1631900048, 1632700043, 1633500024, 1701000056, 1701600055, 1701800042 1704500037, 1705300070, 1706100042, 1707600055, 1706600103, 1707900056, 1708900035, 1710700038, 1712400062, 1713600042, 1714400058, 1715200088, 1715800067

Distribution pattern

Nationwide

device · product 6 of 16

SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS S5 PACK W/CARDIOPLEGIA-3D, (a) REF 044042600 AND (b) REF 044011200, STERILE EO, Rx Only, 1 EA

Z-2788-2017
Recall number
Z-2788-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
733 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: (a) 1703100033, 1703200057, 1705400037, 1707900050, 1708200042, 1710200084, 1713700057, 1715900028 (b) 1619500015, 1620300020, 1623000025, 1623700026, 1624400017, 1625100125, 1626500068, 1627900033, 1628600023, 1629400030, 1632800035, 1634200023, 1634900050, 1635600025, 1700300019, 1700500032, 1702300048, 1703200053, 1703900069

Distribution pattern

Nationwide

device · product 7 of 16

SORIN GROUP, SMART PERFUSION PACK, PUMP AND TABLE PACK, REF 627374101, STERILE EO, Rx Only, 1 EA

Z-2789-2017
Recall number
Z-2789-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
5 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Number 1703300074

Distribution pattern

Nationwide

device · product 8 of 16

SORIN GROUP, SMART PERFUSION PACK, SMART 3/16" PEDS PACK, REF 627263601, STERILE EO, Rx Only, 1 EA

Z-2790-2017
Recall number
Z-2790-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
32 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1621400046, 1623100048, 1706100049, 1706500064

Distribution pattern

Nationwide

device · product 9 of 16

STERILE SAMPLE SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127703, STERILE EO, Rx Only, 1 EA

Z-2791-2017
Recall number
Z-2791-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
1 unit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Number 1709500117

Distribution pattern

Nationwide

device · product 10 of 16

SORIN GROUP, SMART PERFUSION PACK, NEONATE/PEDIATRIC PACK, REF 627127702, STERILE EO, Rx Only, 1 EA

Z-2792-2017
Recall number
Z-2792-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
54 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1620000113, 1622400049, 1624300090, 1631200072, 1632100059, 1632800059, 1633300054, 1705100057, 1711500053

Distribution pattern

Nationwide

device · product 11 of 16

SORIN GROUP, SMART PERFUSION PACK, TOTAL VISION SYSTEM-SMA, REF 084510101, STERILE EO, Rx Only, 1 EA

Z-2793-2017
Recall number
Z-2793-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
8 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1622100055, 1625200039, 1629800049

Distribution pattern

Nationwide

device · product 12 of 16

SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8S, REF 044036101, STERILE EO, Rx Only, 1 EA

Z-2794-2017
Recall number
Z-2794-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
1 unit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Number 1717300032

Distribution pattern

Nationwide

device · product 13 of 16

SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA

Z-2795-2017
Recall number
Z-2795-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
4 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Numbers: 1621400045, 1628600043

Distribution pattern

Nationwide

device · product 14 of 16

NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, INSPIRE 8FS, REF 044043700, 1 EA, NOT FOR CLINICAL USE

Z-2796-2017
Recall number
Z-2796-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
1 unit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Number 1627300090

Distribution pattern

Nationwide

device · product 15 of 16

NON-STERILE SAMPLE, SORIN GROUP, SMART CARDIOPLEGIA, CARDIOPLEGIA PACK, REF 627366901, 1 EA, NOT FOR CLINICAL USE

Z-2797-2017
Recall number
Z-2797-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
1 unit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Number 1623100001

Distribution pattern

Nationwide

device · product 16 of 16

NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE

Z-2798-2017
Recall number
Z-2798-2017
Initiated
June 29, 2017
Classification
Class II
Status
Terminated
Recalling firm
Sorin Group USA, Inc.
Quantity
1 unit

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
sterile barrier breach

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customers.

Code information

Lot Number 1703700067

Distribution pattern

Nationwide