Recall Z-2614-2023
Abbott Medical · initiated August 16, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 111020960 111011436 111020992 810015820 810015794 111009835 111004271 111003046 111024175 111022969 111009840 810019313 810018954 111021002 111009844 810008620 111010818 810018999 111021710 810016110…
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.
FDA-determined cause: Component design/selection
Action taken
On 08/16/2023, the firm sent to U.S. customers an "URGENT MEDICAL DEVICE CORRECTION" Letter (via mail, email or hand-delivery) informing physicians and healthcare professionals that there is a potential for a Bluetooth (BLE) circuit component issue on a subset of Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators manufactured prior to April 2022. The issue is associated with a risk of loss of Bluetooth communication (and therefore a loss of remote monitoring), higher-than-normal current consumption, and reduced device battery longevity. Patient Management Recommendations: 1. Prophylactic device replacement is not recommended as new firmware version pr00.10.87.04 eliminates the potential for loss of therapy between follow-up due to unrecognized decreased device longevity. 2. Determine the firmware version of devices followed at clinics by reviewing the instructions in Appendix A and the device list in Appendix B. 3. Patients with firmware version pr00.10.87.00 or firmware version undetermined, upgrade devices to firmware version pr00.10.87.04: -Prioritize in-clinic firmware upgrade for the specific devices from the 1,500 device sub-group (listed in Appendix B) -For remaining patients, schedule the next follow-up in clinic to complete firmware upgrade. 3. Following firmware upgrade, continue to follow patients routinely 4. If device experience a loss of Bluetooth communication, contact Abbott Technical Support at 1-800-722-3774 (U.S.). In addition, a list of Abbott advisories is available at https://www.cardiovascular.abbott/us/en/hcp/product-advisories.html Abbott has also include a web version of the Customer Notification Letter at https://www.cardiovascular.abbott/content/dam/cv/cardiovascular/pdf/reports/US-Abbott-Communication-BLE-Communication-Final-FDA-v2.pdf
Details
- Recall number
- Z-2614-2023
- Initiated
- August 16, 2023
- Posted by FDA
- September 19, 2023
- Product code
- LWS – Implantable Cardioverter Defibrillator (Non-Crt)
- Quantity
- 38,033 devices
- Distribution
- 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…
- Recalling firm
- Abbott Medical, Sylmar, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2615-2023 Class II | Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q…Due to Bluetooth malfunction on a subset of Implantable Cardioverter Defibrillator (ICD) and Cardia… | 08/16/2023Open, Classified |