Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q — Class II medical device recall Z-0990-2022
Ongoing recall by St. Jude Medical, Cardiac Rhythm Management Division, reported 2022-04-27, distributed nationwide. Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an induct
| Recall number | Z-0990-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | St. Jude Medical, Cardiac Rhythm Management Division, Sylmar, CA, United States |
| Recall initiated | 2022-03-10 |
| Classified | 2022-04-21 |
| Reported by FDA | 2022-04-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | CZ, FR |
| Quantity | 1 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05415067032010 |
| Model numbers | 111004346, CDHFA500Q |
| Expiration dates | 2022-06-30 |
Product
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
Reason for recall
Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.
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-0990-2022. 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.