FDA Device recall Z-2052-2017
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-2052-2017 |
| 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; 106015 - HMII LVAD SEALED KIT-PCTRL, NA UDI: 00813024011224 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-14810, PC-14828, PC-14843, PC-14846, and PC-14848. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2052-2017%22
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