Home › Device types › DSQ
Ventricular (Assist) Bypass
FDA product code DSQ · Class 3 · Unknown
345
Registered devices
157,430
Adverse events
131
Recalls
0
510(k) clearances
Devices with this code
Thoratec® VAD, Cannula Attachment Tool — Thoratec CorporationEXCOR® — Berlin Heart GmbHTHORATEC® HEARTMATE® GOGEAR®, CONSOLIDATED BAG, BEIGE — Thoratec CorporationTHORATEC® HEARTMATE® GOGEAR®, HOLSTER VEST, LARGE — Thoratec CorporationTHORATEC® HEARTMATE®, SYSTEM MONITOR — Thoratec CorporationTHORATEC® VAD, RVAD PNEUMATIC LEAD 5FT — Thoratec CorporationTHORATEC®, HEARTTOUCH® TABLET LI-ION BATTERY — Thoratec CorporationHeartMate™ GoGear™ — Thoratec CorporationHeartMate®, 14V Rechargeable Li-ion Battery — Thoratec CorporationHeartMate 3™ — Thoratec CorporationHeartMate II®, System Controller — Thoratec CorporationData Cable — Heartware Inc.HeartMate™ — Thoratec CorporationEXCOR® — Berlin Heart GmbHEXCOR® — Berlin Heart GmbHTHORATEC® PVAD™, ATRIAL CANNULA - SHORT, BEVELED TIP WITH SIDE HOLES — Thoratec CorporationEXCOR® — Berlin Heart GmbHHVAD® Pump Outflow Graft — Heartware Inc.HeartWare® Controller AC Adapter — Heartware Inc.Explant Kit — Heartware Inc.HeartWare® Controller AC Adapter — Heartware Inc.HVAD® Pump Implant Kit (Enhanced) — Heartware Inc.EXCOR® — Berlin Heart GmbHTHORATEC® HEARTMATE® XVE AND HEARTMATE II®, HEARTMATE TO POWER BASE UNIT CABLE — 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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