FDA Device recall Z-2615-2023

Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrilla…

FDA Device
Class II
ongoing
Published 2023-09-27

On 2023-09-27 the FDA classified a Class II recall of Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization Therapy Defibrilla… by Abbott Medical, citing due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia Resynchronization Therapy Defibrillator *CRT-D) devices that were manufactured….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2615-2023
Classification	Class II
Status	ongoing
Initiated	2023-08-16
Published	2023-09-27
Last updated	2026-09-13 11:56 UTC
Company	Abbott Medical
Distribution	n/a

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

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.

Identifiers

code_info	Gallant: Model Number: HF CRT-D REF CDHFA500Q UDI-DI Code: 05415067032010 Serial Numbers: 111023714 111033397 111026077… Gallant: Model Number: HF CRT-D REF CDHFA500Q UDI-DI Code: 05415067032010 Serial Numbers: 111023714 111033397 111026077 111008528 810007304 810023031 111009077 810007164 111036262 111026540 111013180 810020124 111040419 111042048 810022176 111029687 111006406 111017718 810008795 111012956 111016597 810022867 810018823 810006029 810027443 810000072 810016983 111011034 111015410 810006013 111009628 111018199 111030383 810026178 111037835 111038995 111039205 111039169 111039213 111039103 111039227 111039172 111039154 111039298 111038919 111040351 111037720 111037178 111037142 111005031 810019888 810007234 111028528 111001728 111001715 111000681 111000233 111000202 111000235 111001707 111001777 111000294 111015428 111000224 111000494 111016493 111015792 111001752 111001687 111021218 111021101 111009661 111010339 111010612 111010599 111010615 111036821 111043197 111037844 111014472 111005935 111014496 111006045 111006001 111016094 810027416 810000369 810003198 111028551 111028566 111028556

code_info

Gallant: Model Number: HF CRT-D REF CDHFA500Q UDI-DI Code: 05415067032010 Serial Numbers: 111023714 111033397 111026077…

Gallant: Model Number: HF CRT-D REF CDHFA500Q UDI-DI Code: 05415067032010 Serial Numbers: 111023714 111033397 111026077 111008528 810007304 810023031 111009077 810007164 111036262 111026540 111013180 810020124 111040419 111042048 810022176 111029687 111006406 111017718 810008795 111012956 111016597 810022867 810018823 810006029 810027443 810000072 810016983 111011034 111015410 810006013 111009628 111018199 111030383 810026178 111037835 111038995 111039205 111039169 111039213 111039103 111039227 111039172 111039154 111039298 111038919 111040351 111037720 111037178 111037142 111005031 810019888 810007234 111028528 111001728 111001715 111000681 111000233 111000202 111000235 111001707 111001777 111000294 111015428 111000224 111000494 111016493 111015792 111001752 111001687 111021218 111021101 111009661 111010339 111010612 111010599 111010615 111036821 111043197 111037844 111014472 111005935 111014496 111006045 111006001 111016094 810027416 810000369 810003198 111028551 111028566 111028556

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2615-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.