Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Neutrino HF Cardiac Resynchronization

FDA device recall Z-2615-2023 · posted 2023-09-19 · Open, Classified

Recall details

Recalling firm

Abbott Medical

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.

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

Root cause

Component design/selection

Status

Open, Classified

Product code

NIK

Quantity affected

29,088 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, Lat

Date initiated

2023-08-16

Date posted

2023-09-19

Location

Sylmar, CA