Recall Z-2614-2023 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
Abbott Medical
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 Cardi
| Date | Sep 19, 2023 (initiated Aug 16, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | 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 Manag |
| 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, Polan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.