Brand Name: HeartMate Product Name: HeartMate 3 Controller — Class II medical device recall Z-0506-2026
Ongoing recall by Thoratec LLC, reported 2025-11-26, distributed nationwide. Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup B
| Recall number | Z-0506-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec LLC, Pleasanton, CA, United States |
| Recall initiated | 2025-10-09 |
| Classified | 2025-11-14 |
| Reported by FDA | 2025-11-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DZ, EE, EG, ES, FI, FR, GB, GR, IE, IL, IN, IQ, IR, IT, JP, KR, KW, KY, LB, LT, MA, MY, NL, NO, NZ, OM, PE, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, TH, TN, TR, TW, ZA |
| Quantity | 35,376 |
| UPC / GTIN / UDI-DI | 05415067038982, 05415067039422, 05415067039446 |
| Model numbers | 106531INT, 106531LF2, 106531US |
Product
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate 3" System Controller acts as the central power and communication hub for the HeartMate 3 LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline. The HeartMate 3 System Controller constantly monitors system performance through communication with the implanted LVAD and Controller internal measurements and alerts the user to any alarm conditions by activating membrane panel LEDs and integrated audio annunciators. Further information on alarm conditions as well as system status can be attained by the user from the front panel LCD on the System Controller. When connected to a HeartMate Touch" Communication System, the System Controller sends information regarding the System Controller and Pump Status once per second to provide additional information to the user. This link also allows the clinician to set new patient operating parameters (e.g. pump speed) and provides a link for downloading trend and/or event recorder data. Component: Yes, HeartMate 3 LVAS
Reason for recall
Due to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm.
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-0506-2026. 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.