Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2024-06-26Open, ClassifiedNonconforming Material/Component

  COBALT HF QUAD CRT-D MRI SureScan, Model Number DTPB2QQ, Implantable Cardioverter Defibrillator

  Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

• 2024-06-26Open, ClassifiedNonconforming Material/Component

  COBALT XT HF CRT-D MRI SureScan, Model Number: DTPA2D1, Implantable Cardioverter Defibrillator

  Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

• 2024-06-26Open, ClassifiedNonconforming Material/Component

  Cobalt XT HF CDT-D MRI SureScan, Model Number: DTPA2D4, Implantable Cardioverter Defibrillator

  Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

• 2024-06-26Open, ClassifiedNonconforming Material/Component

  COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator

  Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

• 2024-06-26Open, ClassifiedNonconforming Material/Component

  COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2QQ, Implantable Cardioverter Defibrillator

  Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

• 2024-06-26Open, ClassifiedNonconforming Material/Component

  CROME HF QUAD CRT-D MRI SureScan, Model Number DTPC2QQ, Implantable Cardioverter Defibrillator

  Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

• 2023-09-19Open, ClassifiedComponent design/selection

  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.

• 2023-06-16Open, ClassifiedUnder Investigation by firm

  CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; Implantable Cardioverter Defibrillators

  There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

• 2023-06-16Open, ClassifiedUnder Investigation by firm

  CRT-D DTBA1D1G DF1 VIVA XT US GOLD CTD, Model Number DTBA1D1G; Implantable Cardioverter Defibrillators

  There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

• 2023-06-16Open, ClassifiedUnder Investigation by firm

  CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; Implantable Cardioverter Defibrillators

  There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.