HeartMate 3 System Controllers provided within the following… — Class II medical device recall Z-2583-2024
Ongoing recall by Thoratec LLC, reported 2024-08-21, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing
| Recall number | Z-2583-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec LLC, Pleasanton, CA, United States |
| Recall initiated | 2024-06-25 |
| Classified | 2024-08-13 |
| Reported by FDA | 2024-08-21 |
| Distributed | AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CO, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IQ, IR, IT, KR, KW, KY, LB, LT, MA, NL, NO, NZ, OM, PL, PT, QA, RO, RS, SA, SE, SI, TN, TR, TW, ZA |
| Quantity | 694 |
| UPC / GTIN / UDI-DI | 00813024011712, 00813024011842, 00813024013235, 00813024013297, 05415067031105 |
| Serial numbers | HSC-134244, HSC-134245, HSC-134246, HSC-134247, HSC-134252, HSC-134253, HSC-134254, HSC-134255, HSC-134256, HSC-134257, HSC-134258, HSC-134259, HSC-134260, HSC-134261, HSC-134263, HSC-134264, HSC-134265, HSC-134266, HSC-134267, HSC-134268, HSC-134269, HSC-134270, HSC-134271, HSC-134272, HSC-134274 and 475 more |
| Model numbers | 106524INT, 106524US, 106531INT, 106531LF2, 106531US |
Product
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System (LVAS) Implant Kits or distributed separately: HeartMate 3 LVAS Implant Kit, US, Model: 106524US; HeartMate 3 LVAS Implant Kit, OUS, Model: 106524INT; HeartMate 3 System Controller, US, Model: 106531US; HeartMate 3 System Controller, OUS, Model: 106531INT; HeartMate 3 System Controller Low Flow 2.0, Global, Model: 106531LF2
Reason for recall
Left ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to fluid, ingress may occur, which may damage printed circuit board assemblies, which could result in unexpected and false positive alarms, loss of visual alarms, loss of user interface(use of buttons, loss of visual alarms,etc.), loss of power, and pump stop
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-2583-2024. 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.