FDA Device recall Z-2053-2017
HeartMate¿ II LVAS with Pocket Controller
- FDA Device
- Class I
- terminated
- Published 2017-05-31
On 2017-05-31 the FDA classified a Class I recall of HeartMate¿ II LVAS with Pocket Controller by Thoratec, citing st. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller eas….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2053-2017 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2017-03-30 |
| Published | 2017-05-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Thoratec |
| Distribution | n/a |
Product
HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER, NA; UDI: 00813024011286 Intended to provide hemodynamic support in patients with end-stage, refractory left ventricular heart failure; intended for use inside or outside the hospital.
Reason
St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software and updates to hardware to make the exchange to a backup controller easier. This is related to recall Z-1227/1230-2014.
Identifiers
| code_info | Serial Numbers PC-10255-B, PC-10329-B, PC-10357-B, PC-10476-B, PC-10478-B, PC-10486-B, PC-10518-B, PC-10519-B, PC-1052…Serial Numbers PC-10255-B, PC-10329-B, PC-10357-B, PC-10476-B, PC-10478-B, PC-10486-B, PC-10518-B, PC-10519-B, PC-10524-B, PC-10525-B, PC-10538-B, PC-10540-B, PC-10544-B, PC-10626-B, PC-10629-B, PC-10973-C, PC-10976-C, PC-10977-C, PC-10986-C, PC-10988-C, PC-11017-C, PC-11018-C, PC-11019-C, PC-11027-C, PC-11041-C, PC-11044-C, PC-11050-C, PC-11055-C, PC-11056-C, PC-11063-C, PC-11068-C, PC-11073-C, PC-11077-C, PC-11082-C, PC-11083-C, PC-11085-C, PC-11086-C, PC-11090-C, PC-11104-C, PC-11105-C, PC-11106-C, PC-11136-C, PC-11142-C, PC-11150-C, PC-11151-C, PC-11152-C, PC-11156-C, PC-11163-C, PC-11164-C, PC-11168-C, PC-11200-C, PC-11209-C, PC-11228-C, PC-11231-C, PC-11233-C, PC-11234-C, PC-11236-C, PC-11237-C, PC-11239-C, PC-11240-C, PC-11246-C, PC-11248-C, PC-11249-C, PC-11251-C, PC-11253-C, PC-11255, PC-11256-C, PC-11258, PC-11261-C, PC-11262-C, PC-11263-C, PC-11264-C, PC-11265-C, PC-11268-C, PC-11270-C, PC-11272-C, PC-11273-C, PC-11275-C, PC-11276-C, PC-11278-C, PC-11279-C, PC-11282-C, PC-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 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-2053-2017%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.