Cobalt™ XT HF CRT-D MRI SureScan™ DTPA2D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 452 adverse event reports that list this exact device (DI 00763000178130), received between Mar 18, 2021 and Sep 28, 2026 — classified as 12 deaths, 301 injuries, 139 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (68 reports).

4 FDA recall records name this device's identifier, 4 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 16, 2024Class IIOpen, Classified

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

   Z-2192-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. May 10, 2023Class IOpen, Classified

   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.

   Z-1777-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jun 22, 2022Class IOpen, Classified

   There is the potential for reduced shock energy (~79% of programmed energy) during high-voltage (HV) therapy for Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

   Z-1486-2022 · Root cause: Device Design · Recall details · FDA record ↗

4. Apr 12, 2022Class IIOpen, Classified

   Telemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).

   Z-1267-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 452 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918505 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50901154 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886465 ↗
• DeathSep 22, 2026Failure to Deliver Shock/Stimulation

  It was reported by the patient's family that the patient expired. The patient's family stated the Cardiac Resynchronization Therapy Defibrillator (CRT-D) did not shock the patient and wanted to know why. It was further reported that the CRT-D was not checked after the patient expired.

  Patient problems: Insufficient Information

  MAUDE report 50861684 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma; Pain

  MAUDE report 50811506 ↗
• InjurySep 15, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device provided inappropriate therapy for detected Ventricular Tachycardia (VT) episodes that were suspected Supra Ventricular Tachycardia (SVT). The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50776652 ↗
• InjurySep 14, 2026Migration or Expulsion of Device

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) had not been sutured during the implant procedure, and it had migrated downward in the pocket which pulled the slack out of the leads. It was further reported that the Right Ventricular (RV) lead had partially dislodged. The CRT-D and the RV lead were explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756048 ↗
• MalfunctionSep 10, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50723744 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50697523 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia leading to septicemia post generator change. The patient was hospitalized and treated with antibiotics. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system remains in use. The patient is a part icipant in a clinical study. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50671196 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50620069 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50575178 ↗
• MalfunctionSep 2, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50567515 ↗
• MalfunctionSep 1, 2026Pacing Problem; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) had atrial event that were failing in the blanking period with observed device classified termination of Atrial Tachycardia/Atrial Fibrillation (AT/AF) detected events with  inappropriate atrial pacing noted at times. The device remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547931 ↗
• InjuryAug 28, 2026Device Sensing Problem

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times and false terminating of events. The patient was stated to have been post cardiac arrest.  Per remote monitoring transmission report the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited  misdetection for monitored episodes  of Supra Ventricular Tachycardia (SVT) versus Ventricular Tachycardia (VT). The device and lead remains in use. No patient complications have been reported as a result of this event

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507286 ↗
• MalfunctionAug 25, 2026Pacing Problem

  Patient problems: Bradycardia

  MAUDE report 50440349 ↗
• InjuryAug 25, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) Supra Ventricular Tachycardia (SVT) discriminator i nappropriately detected Ventricular Tachycardia (VT) as SVT and therapies were not delivered. The device was reprogrammed and remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50434061 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient experienced a pocket infection. The device was revised  and revision location div into sub pectoral left side removal. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50371060 ↗
• InjuryAug 12, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50226626 ↗
• MalfunctionAug 11, 2026Electromagnetic Interference

  Patient problems: Electric Shock

  MAUDE report 50216279 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a septic pocket infection approximately one month post-system implant. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a leadless pacemaker. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Sepsis

  MAUDE report 50175431 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported a pocket infection occurred with Purulent Discharge/Pus, Swelling and Wound Dehiscence. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 50070489 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION THAT PRESENTED WITH PURULENT DISCHARGE, PUS, AND SWELLING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 25786109 ↗
• InjuryJul 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED THREE MONTHS POST-IMPLANT DUE TO WOUND DEHISCENCE AND INFECTION WITH PURULENT DISCHARGE AND REDNESS NOTED. A NEW SYSTEM WAS IMPLANTED A FEW DAYS LATER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 25781028 ↗
• MalfunctionJul 9, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT THERE WAS SETSCREW STUCK. THE DEVICE WAS NOT IMPLANT AND WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25772448 ↗