HeartMate¿ II LVAS with Pocket Controller — Class I medical device recall Z-2053-2017
Terminated recall by Thoratec Corporation, reported 2017-05-31. St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with new software an
| Recall number | Z-2053-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corporation, Pleasanton, CA, United States |
| Recall initiated | 2017-03-30 |
| Classified | 2017-05-24 |
| Reported by FDA | 2017-05-31 |
| Terminated | 2019-03-20 |
| Countries outside the US | AE, AT, BE, BR, CA, CH, CL, CZ, DE, DK, EE, EG, ES, FR, GB, GR, HK, HR, HU, IE, IL, IN, IR, IT, KW, KY, LB, LT, LV, MY, NL, PL, QA, RS, SA, SE, SG, SI, SK, TH, TR |
| Quantity | 24,077 active |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00813024011286 |
| 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 and 475 more |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2053-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.