Reported Sep 27, 2023 · Ongoing
Gallant VR Implantable Cardioverter Defibrillator
Abbott Medical
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott Medical · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
Gallant VR Implantable Cardioverter Defibrillator
6 of 6 products
| Model / number | Product as published |
|---|---|
CDVRA500Q | Gallant DR Implantable Cardioverter Defibrillator: DR ICD |
CDDRA500Q | Neutrino VR Implantable Cardioverter Defibrillator: NxT VR ICD |
CDVRA600Q | Neutrino DR Implantable Cardioverter Defibrillator: NxT DR ICD |
CDDRA600Q | Entrant VR Implantable Cardioverter Defibrillator: VR ICD |
CDVRA300Q | Entrant DR Implantable Cardioverter Defibrillator: DR ICD |
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. |
- Lot codes and dates
- GallantModel
- NumberVR
- ICD REF CDVRA500Q UDI-DI Code05415067031990
- Serial Numbers81
3,251 of 3,251 codes
111033498810000696810002524111031208111025117111030959111006327111028481111014296111033775810021414810001946810001996810002011810001942810007459111036536810019608810019393810019581111042257810026722810028531810028585810027003111011936810021423111025530111015227111036960810026790111036957111036933111036964111007506810021413810021445810021449111033604111000553111000558111000567111000472111000706111000667111006793111000664111000678111018664111018644111018802111012460111006783111006791111006789111000786111000582111000550111000721111001035
- Amount recalled
- 38,033 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Abbott Medical recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.