Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D… — Class II medical device recall Z-2615-2023
Ongoing recall by Abbott Medical, reported 2023-09-27, distributed nationwide. Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchron
| Recall number | Z-2615-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Medical, Sylmar, CA, United States |
| Recall initiated | 2023-08-16 |
| Classified | 2023-09-19 |
| Reported by FDA | 2023-09-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CH, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HU, IE, IN, IT, KR, KW, LB, LT, LU, LV, MY, NL, NO, NP, NZ, OM, PL, PT, QA, RO, RS, RU, SA, SE, SG, SI, SK, TH, TW |
| Quantity | 29,088 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 05415067032010, 05415067032850, 05415067034359 |
| Serial numbers | 101000003, 101000004, 101000005, 101000006, 101000007, 101000009, 101000010, 101000011, 101000012, 101000013, 101000049, 101000050, 101000052, 101000056, 101000057, 101000059, 111000119, 111000121, 111000122, 111000124, 111000126, 111000129, 111000132, 111000134, 111000135 and 475 more |
| Model numbers | CDHFA300Q, CDHFA500Q, CDHFA600Q |
Product
Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrillator: NxT HF CRT-D REF CDHFA600Q Entrant HF Cardiac Resynchronization Therapy Defibrillator : HF CRT-D REF CDHFA300Q The primary function of ICDs and CRT-Ds are to treat life-threatening ventricular tachyarrhythmias via anti-tachycardia pacing (ATP), or cardioversion/defibrillation. Implantable Cardioverter Defibrillators (ICDs) can either be a dual chamber (also known as DR if rate responsive) device that is connected to a right atrial (RA) pacing lead and right ventricular defibrillation lead or single chamber ICD (also known as VR if rate responsive) with only a defibrillation lead in the right ventricle (RV). The ICD, more generally known as an implantable pulse generator (IPG), is typically implanted in a subcutaneous device pocket located in the pectoral region and is attached to the pacing/defibrillator leads that are implanted through the transvenous technique with the distal tips positioned in the RA (dual chamber) and RV. Cardiac Resynchronization Therapy Defibrillator (CRT-D) systems consist of a right atrial (RA) pacing lead, a right ventricular (RV) defibrillation lead, as well as a third lead placed in the coronary venous system overlying the left ventricle (LV) to improve ventricular resynchronization through biventricular pacing for treatment of heart failure. CRT-D devices, more generally known as an implantable pulse generator (IPG), are typically implanted in a subcutaneous device pocket located in the pectoral region and are attached to the pacing/defibrillator leads that are implanted through transvenous technique.
Reason for recall
Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured prior to April 2022 as a result of crystal component issue within the Bluetooth Low Energy (BLE) circuit. This results in the device entering an inductive telemetry only mode with loss of Bluetooth communication. In some instances, thought BLE communication is unavailable, the circuit may remain in a state which draws excessive power affecting 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-2615-2023. 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.