FDA Device recall Z-2614-2023

Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA…

FDA Device
Class II
ongoing
Published 2023-09-27

On 2023-09-27 the FDA classified a Class II recall of Gallant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA… 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-2614-2023
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 VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA500Q Gallant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA500Q Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD REF CDVRA600Q Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD REF CDDRA600Q Entrant VR Implantable Cardioverter Defibrillator: VR ICD REF CDVRA300Q Entrant DR Implantable Cardioverter Defibrillator: DR ICD REF CDDRA300Q 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: VR ICD REF CDVRA500Q UDI-DI Code: 05415067031990 Serial Numbers: 111033498 810000696 810002524 1… Gallant: Model Number: VR ICD REF CDVRA500Q UDI-DI Code: 05415067031990 Serial Numbers: 111033498 810000696 810002524 111031208 111025117 111030959 111006327 111028481 111014296 111033775 810021414 810001946 810001996 810002011 810001942 810007459 111036536 810019608 810019393 810019581 111042257 810026722 810028531 810028585 810027003 111011936 810021423 111025530 111015227 111036960 810026790 111036957 111036933 111036964 111007506 810021413 810021445 810021449 111033604 111000553 111000558 111000567 111000472 111000706 111000667 111006793 111000664 111000678 111018664 111018644 111018802 111012460 111006783 111006791 111006789 111000786 111000582 111000550 111000721 111001035 111001025 111014950 111021456 111021461 111021703 111021722 111021450 111036417 111012272 111011597 810001013 810001011 810006759 810001046 810001021 810019014 111024417 810002439 111024415 810006774 111024454 810022318 111036914 810013066 810015963 111002002 810021662 810013192 810011364 111003380 810011481 11

code_info

Gallant: Model Number: VR ICD REF CDVRA500Q UDI-DI Code: 05415067031990 Serial Numbers: 111033498 810000696 810002524 1…

Gallant: Model Number: VR ICD REF CDVRA500Q UDI-DI Code: 05415067031990 Serial Numbers: 111033498 810000696 810002524 111031208 111025117 111030959 111006327 111028481 111014296 111033775 810021414 810001946 810001996 810002011 810001942 810007459 111036536 810019608 810019393 810019581 111042257 810026722 810028531 810028585 810027003 111011936 810021423 111025530 111015227 111036960 810026790 111036957 111036933 111036964 111007506 810021413 810021445 810021449 111033604 111000553 111000558 111000567 111000472 111000706 111000667 111006793 111000664 111000678 111018664 111018644 111018802 111012460 111006783 111006791 111006789 111000786 111000582 111000550 111000721 111001035 111001025 111014950 111021456 111021461 111021703 111021722 111021450 111036417 111012272 111011597 810001013 810001011 810006759 810001046 810001021 810019014 111024417 810002439 111024415 810006774 111024454 810022318 111036914 810013066 810015963 111002002 810021662 810013192 810011364 111003380 810011481 11

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-2614-2023%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.