Home › Device types › DSQ
Ventricular (Assist) Bypass
FDA product code DSQ · Class 3 · Unknown
349
Registered devices
158,821
Adverse events
131
Recalls
0
510(k) clearances
Devices with this code
HEARTMATE®, SYSTEM MONITOR TO POWER MODULE CABLE — Thoratec CorporationHeartWare® Battery — Heartware Inc.HeartMate II® Unshielded 14V Patient Cable — Thoratec CorporationTHORATEC® HEARTMATE® GOGEAR®, MODULAR BELT, SMALL-MEDIUM — Thoratec CorporationThoratec® HeartMate 3™ — Thoratec CorporationThoratec® HeartMate 3™ — Thoratec CorporationThoratec® HeartMate 3™ Surgical Hand Tools — Thoratec CorporationTHORATEC® HEARTMATE® GOGEAR®, HOLSTER VEST, LARGE — Thoratec CorporationHeartMate™ — Thoratec CorporationHVAD® Pump Outflow Graft — Heartware Inc.THORATEC® HEARTMATE® GOGEAR®, CONSOLIDATED BAG, BLACK — Thoratec CorporationHeartMate II®, System Controller — Thoratec CorporationHeartWare® Controller AC Adapter — Heartware Inc.HEARTMATE, 14V LI-ION RECHARGEABLE BATTERY SET (SING) — Thoratec CorporationHeartMate 3™ — Thoratec CorporationAB5000 — Abiomed, Inc.HeartWare® Controller DC Adapter — Heartware Inc.HeartMate 3™ — Thoratec CorporationCentriMag™ — Thoratec CorporationHeartWare® Monitor — Heartware Inc.HeartMate II®, System Controller — Thoratec CorporationHVAD® Pump Surgical Tools – Extended Length — Heartware Inc.EXCOR® — Berlin Heart GmbHHeartMate™ — Thoratec Corporation
Recent 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 an |
| 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 an |
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