FDA Device recall Z-1300-2024
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS I…
- FDA Device
- Class I
- ongoing
- Published 2024-03-27
On 2024-03-27 the FDA classified a Class I recall of HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS I… by Thoratec, citing observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1300-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-02-19 |
| Published | 2024-03-27 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Thoratec |
| Distribution | US |
Product
HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II Sealed Outflow Graft with Bend Relief REF 103393 2. HeartMate II LVAS Implant Kit, US REF 106015 3. HeartMate II LVAS Implant Kit, OUS REF 106016 Update (February 14, 2024) HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II LVAS Implant Kit, OUS REF 102139 2. HeartMate II LVAS Implant Kit, US REF 1355 3. HeartMate II LVAS Implant Kit (with RSOC Controller), US REF 103695 4. HeartMate II LVAS Implant Kit (with RSOC Controller), OUS REF 103693 5. HeartMate II LVAS Implant Kit (with Sealed Graft), US REF 104911 6. HeartMate II LVAS Implant Kit (with Sealed Graft), OUS REF 104912 7. HeartMate II LVAS Implant Kit (Used for pump exchange, No Graft) REF 107801 8. HeartMate II LVAS Implant Kit, (EPC), CANADA REF 103695-CAN 9. HeartMate II LVAS Implant Kit (with Sealed Graft), JAPAN REF 104911JPN 10. HeartMate II LVAS Implant Kit (with Pocket System Controller and Sealed Grafts), for geographies outside of US & EU REF 106515OUS HeartMate II Left Ventricular Assist System: The HeartMate II LVAS is an axial-flow, rotary ventricular assist system. One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
Reason
Observed outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System.
Identifiers
| code_info | HeartMate II LVAS Model Numbers: 1. 103393 (cannot be implanted without a LVAD) 2. 106015 (US) 3. 106016 (OUS) U…HeartMate II LVAS Model Numbers: 1. 103393 (cannot be implanted without a LVAD) 2. 106015 (US) 3. 106016 (OUS) Update (February 14, 2024) HeartMate II LVAS: 1. 102139 (OUS), includes Unsealed Outflow Graft with Bend Relief 2. 1355 (US), includes Unsealed Outflow Graft with Bend Relief 3. 103695 (US), includes Unsealed Outflow Graft with Bend Relief 4. 103693 (OUS), includes Unsealed Outflow Graft with Bend Relief 5. 104911 (US) 6. 104912 (OUS) 7. 107801 (US), does not include Outflow Graft 8. 103695-CAN, includes Unsealed Outflow Graft with Bend Relief 9. 104911JPN 10. 106515OUS UDI-DI codes: HeartMate II LVAS: 1. 00813024010807 2. 00813024011224 3. 00813024011231 Update (February 14, 2024) HeartMate II LVAS: 1. N/A 2. 00813024010005 3. 00813024010616 4. 00813024010623 5. 00813024011170 6. 00813024010821 7. 00813024011996 8. N/A 9. 00813024011682 10. 00813024011682 Serial Numbers: US VAD-0357 VAD-0638 VAD-10113 VAD-10162 VAD-10198 VAD-10418 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1300-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.