Abbott HeartMate Touch Communication System — Class II medical device recall Z-0308-2022
Ongoing recall by Thoratec Corp., reported 2021-12-08, distributed nationwide. If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device
| Recall number | Z-0308-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thoratec Corp., Pleasanton, CA, United States |
| Recall initiated | 2021-10-22 |
| Classified | 2021-11-26 |
| Reported by FDA | 2021-12-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, CH, CZ, DE, DK, ES, FR, GB, IE, IL, IT, KW, LT, NL, NZ, PL, SA, SE, SG, SI, ZA |
| Quantity | 988 |
| Model numbers | HMT1100 |
Product
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Reason for recall
If LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth connection, the Bluetooth connectivity interference may cause the system App to close or fail to open. Once Bluetooth adaptor is connected, barring disconnection, all functionality is unaffected; the device will continue to operate as expected.
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-0308-2022. 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.