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Gallant HF Cardiac Resynchronization Therapy Defibrillator: HF CRT-D REF CDHFA500Q Recalled by Abbott Medical Due to Due to Bluetooth malfunction on a subset of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Abbott Medical directly.
Affected Products
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.
Quantity: 29,088 devices
Why Was This Recalled?
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.
Where Was This Sold?
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
About Abbott Medical
Abbott Medical has 42 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report