Exact FDA event identifier

Event 92923

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 16, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Abbott Medical

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

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.

Z-2614-2023

Recall number: Z-2614-2023
Initiated: August 16, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Abbott Medical
Quantity: 38,033 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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 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Distribution pattern

U.S.: Nation-wide O.U.S.: Australia, Austria, Bahrain, Belgium, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Malaysia, Nepal, Netherlands, New Zealand, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom. Latin America - Pending

device · product 2 of 2

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.

Z-2615-2023

Recall number: Z-2615-2023
Initiated: August 16, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Abbott Medical
Quantity: 29,088 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

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Code information

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 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