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AB5000
Abiomed, Inc. · Model AB Pump Set 12mm/32 Apical (Sil) · UDI-DI 00813502010381
DSQ
Prescription
0
510(k) clearances
158,082
Adverse events (23,108 deaths)
131
Recalls
23
Facilities
Description
Ventricular (Assist) Bypass
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-13 | Thoratec LLC | Due to 11 volt Backup Battery failures. |
| 2026-05-13 | Thoratec LLC | Due to 11 volt Backup Battery failures. |
| 2026-05-13 | Thoratec LLC | Due to 11 volt Backup Battery failures. |
| 2026-04-24 | BERLIN HEART GMBH | Blood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. |
| 2025-10-09 | Thoratec LLC | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. |
| 2025-10-09 | Thoratec LLC | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. |
| 2025-10-09 | Thoratec LLC | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. |
| 2025-10-09 | Thoratec LLC | Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. |
| 2025-06-23 | Thoratec LLC | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintend |
| 2025-06-23 | Thoratec LLC | Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintend |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.