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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83252

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

Open FDA event record

Event summary

Timeline bucket
June 20, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
St Jude Medical 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

6 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 6

ELLIPSE VR, REF: CD1377-36C Implantable cardioverter defibrillators (ICDs)

Z-2070-2019
Recall number
Z-2070-2019
Initiated
June 20, 2019
Classification
Class I
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
27

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Code information

Serial Number: 9831140, 9831656, 9834078, 9834079, 9834084, 9834177, 9834184, 9834187, 9834307, 9834319, 9834322, 9834323, 9835098, 9835106, 9835107, 9835351, 9835354, 9835356, 9835768, 9835769, 9835771, 9835914, 9835916, 9837174, 9837251, 9837256, 9837606

Distribution pattern

Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO

device · product 2 of 6

ELLIPSE VR, REF: CD1377-36QC Implantable cardioverter defibrillators (ICDs)

Z-2071-2019
Recall number
Z-2071-2019
Initiated
June 20, 2019
Classification
Class I
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
47

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Code information

Serial Number: 1281828, 1281840, 1282688, 1282724, 1282734, 1283113, 1283627, 1283633, 1283634, 1283639, 1283641, 1283643, 1283646, 1283648, 1283656, 1283657, 1283659, 1283660, 1283672, 1283680, 1283681, 1283683, 1283689, 1283690, 1283692, 1283695, 1283697, 1283703, 1283704, 1283708, 1283742, 1283747, 1283749, 1283766, 1283772, 1283780, 1283783, 1283784, 1283788, 1283832, 1283838, 1283845, 1283868, 1283884, 9831441, 9831445, 9831759

Distribution pattern

Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO

device · product 3 of 6

ELLIPSE VR, Tiered-therapy cardioverter/defibrillator, REF: CD1411-36Q, UDI: 05414734507738

Z-2072-2019
Recall number
Z-2072-2019
Initiated
June 20, 2019
Classification
Class I
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
52

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Code information

Serial Number: 9828978, 9829577, 9830723, 9830869, 9831468, 9831616, 9831748, 9831795, 9831810, 9831919, 9833545, 9833546, 9834026, 9834051, 9834053, 9834055, 9834059, 9834063, 9834071, 9834140, 9834145, 9834167, 9834171, 9834256, 9834258, 9834259, 9834262, 9834265, 9834271, 9834272, 9834274, 9834275, 9834277, 9834285, 9834289, 9834291, 9834296, 9834299, 9834301, 9834302, 9834329, 9834398, 9834403, 9834407, 9834409, 9834418, 9834422, 9834423, 9834428, 9834431, 9834432, 9834553

Distribution pattern

Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO

device · product 4 of 6

ELLIPSE DR, REF: CD2377-36QC Implantable cardioverter defibrillators (ICDs)

Z-2073-2019
Recall number
Z-2073-2019
Initiated
June 20, 2019
Classification
Class I
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Code information

Serial Number: 1282011, 1282019, 1282065, 1282069, 1282424, 1282458, 1282469, 1282474, 1282596, 1282602, 1282609, 1282622, 1282625, 1282638, 1282641, 1282648, 9829389, 9831310, 9831509, 9831515, 9831516

Distribution pattern

Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO

device · product 5 of 6

ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36C, UDI: 05414734507585

Z-2074-2019
Recall number
Z-2074-2019
Initiated
June 20, 2019
Classification
Class I
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
15

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Code information

Serial Number: 9836058, 9836059, 9836061, 9836062, 9836063, 9836064, 9836065, 9836066, 9836067, 9836219, 9836220, 9836221, 9838312, 9838544, 9838546

Distribution pattern

Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO

device · product 6 of 6

ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615

Z-2075-2019
Recall number
Z-2075-2019
Initiated
June 20, 2019
Classification
Class I
Status
Terminated
Recalling firm
St Jude Medical Inc.
Quantity
42

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.

Code information

Serial Number: 9829846, 9829991, 9830102, 9830495, 9830497, 9831323, 9831461, 9831788, 9831792, 9831793, 9831899, 9831902, 9833544, 9833845, 9833847, 9833852, 9833930, 9834097, 9834099, 9834102, 9834107, 9834110, 9834115, 9834117, 9834118, 9834119, 9834121, 9834124, 9834207, 9834211, 9834217, 9834357, 9834385, 9834535, 9834536, 9834669, 9834820, 9834952, 9834954, 9834955, 9835491, 9835786

Distribution pattern

Worldwide distribution. US nationwide, and countries: DE, FR, IT, ES, NL, PT, SE, HU, DK, PL, IL, GP, DZ, CH, SA, SK, LU, NZ, VN, and NO