FDA Device recall Z-1227-2014
HeartMate II Implant Kit with Pocket Controller
- FDA Device
- Class I
- terminated
- Published 2014-04-02
On 2014-04-02 the FDA classified a Class I recall of HeartMate II Implant Kit with Pocket Controller by Thoratec, citing discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket S….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1227-2014 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-03-04 |
| Published | 2014-04-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Thoratec |
| Distribution | US |
Product
HeartMate II Implant Kit with Pocket Controller; with sealed grafts (NAm) with sealed grafts (EU) Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
Reason
Discovery of serious injuries and deaths associated with the process of changing from a primary System controller to their back-up System controller in patients using the Pocket System controller model.
Identifiers
| code_info | Catalog number 106015 (NAm) 106016 - EU all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Thoratec
- Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US Software Version: N/A Product Description…
FDA Device · Class II · 2026-06-24 · Thoratec - Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US Software Version: N/A Pr…
FDA Device · Class II · 2026-06-24 · Thoratec - Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128 Software Version: N/A Product Descriptio…
FDA Device · Class II · 2026-06-24 · Thoratec - CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016
FDA Device · Class II · 2026-01-21 · Thoratec - Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US
FDA Device · Class II · 2025-11-26 · Thoratec
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1227-2014%22
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