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.
Recall
- Recall Number
- Z-2615-2023
- Event Number
- 92923
- Firm
- Abbott Medical
- FEI Number
- 2017865
- Product Code
- NIK
- Status
- Open, Classified
- Root Cause
- Component design/selection
- Initiated
- August 16, 2023
- Posted
- September 19, 2023
- Address
- 15900 Valley View Ct, Sylmar, CA, 91342-3577
Description
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.
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.
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
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
29,088 devices