Cobalt™ HF CRT-D MRI SureScan™ DTPB2D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 00763000178222), received between Aug 3, 2020 and Sep 29, 2026 — classified as 3 deaths, 124 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (23 reports).

3 FDA recall records name this device's identifier, 3 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. 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-1781-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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-1488-2022 · Root cause: Device Design · Recall details · FDA record ↗

3. 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 178 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Erosion; Medical device site infection

  MAUDE report 50939941 ↗
• InjuryAug 31, 2026Premature Discharge of Battery

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted and replaced due to premature battery depletion.  No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531391 ↗
• InjuryAug 25, 2026Premature Discharge of Battery

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited premature battery depletion. The CRT-D 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 50442950 ↗
• InjuryJun 4, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT MAY HAVE RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH FAST VENTRICULAR RESPONSE THAT WAS DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR FIBRILLATION (VF). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN R REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25394395 ↗
• InjuryMay 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT "MEDICAL ISSUE TOOK PLACE" WITH HIS PREVIOUS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). "LOOSE WIRE CAME THROUGH PATIENT'S CHEST, WIRES WERE CHANGED AND IT WAS LEFT LOOSE AND IT CAME THROUGH PATIENT'S CHEST". PATIENT "WENT INTO THE EMERGENCY ROOM AND RECEIVED A NEW DEVICE. THE CRT-D WAS REMOVED". THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion

  MAUDE report 25204575 ↗
• DeathMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED BY THE PATIENT¿S FAMILY THAT THE PATIENT WAS IN THE HOSPITAL FOR THE PAST FEW WEEKS FOR CANCER. THE CARDIAC RESYNCHR ONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DEACTIVATED FOR A MAGNETIC RESONANCE IMAGING (MRI) AND THE FAMILY WAS NOT SURE IF THE CRT-D WAS TURNED BACK ON. IT WAS FURTHER REPORTED THAT THE PATIENT EXPIRED THE SAME DAY DUE TO ASPIRATION ON THE LUNGS, AND THE FAMILY THINKS THAT THE PATIENT DIED BECAUSE THE CRT-D WAS NOT TURNED BACK ON.

  Patient problems: Aspiration/Inhalation

  MAUDE report 25131101 ↗
• MalfunctionApr 27, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THERE WAS EPISODES OF POSSIBLE SUSTAINED ARRHYTHMIAS.   WITH OCCASIONAL RATE BELOW DETECTION ZONE, WHICH RESET THE DETECTION COUNTER. THE EPISODES RECORDED AS VENTRICULAR TACHYCARDIA (VT) NON SUSTAINED, BUT POSSIBLY MORE SUSTAINED DUE TO OCCASIONAL BEAT BELOW DETECTION CRITERIA.  THE CRT-D 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 24998976 ↗
• InjuryApr 20, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 24926130 ↗
• InjuryApr 17, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE.  THE RV LEAD REMAINS IN USE.  IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DOES NOT APPEAR TO BE WORKING APPROPRIATELY DUE TO PATIENT GOING IN AND OUT OF VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF).  THE CRT-D REMAINS IN USE.  NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 24910767 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24781781 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A DEVICE SITE INFECTION AND EROSION. A BACK ABSCESS WAS NOTED AS THE SOURCE OF THE INFECTION. THE PATIENT EXPERIENCED DISCOMFORT, PURULENT DISCHARGE AND WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Abscess; Discomfort; Erosion; Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 24649204 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND SUBSEQUENTLY REPLACED DUE TO AN INFECTION WITH BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 24549001 ↗
• InjuryMar 6, 2026Signal Artifact/Noise; High impedance; Mechanical Problem

  IT WAS REPORTED THAT THE LOW POWERED RIGHT VENTRICULAR (RV) LEAD PLACED IN THE LEFT BUNDLE BRANCH (LBB) EXHIBITED UNDEFINED HIGH PACING IMPEDANCE AND THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REPROGRAMMED. THE FOLLOWING DAY, THE PHYSICIAN OPENED THE DEVICE POCKET TO FIND THAT THE RV LEAD WAS NOT SEATED IN THE DEVICE HEADER AND ¿COMPLETELY CAME OUT OF THE HEADER¿ WHEN THE DEVICE WAS REMOVED FROM THE POCKET. THE RV LEAD WAS TESTED WITH AN ANALYZER, HAD NORMAL VALUES, AND WAS RE-CONNECTED TO THE DEVICE.IT WAS THEN NOTICED THAT SINCE THE PHYSICIAN HAD REMOVED THE DEVICE FROM THE POCKET, THE RIGHT ATRIAL (RA) LEAD SLACK HAD BEEN PULLED. THE RA LEAD WAS THEN DISCONNECTED FROM THE DEVICE, SLACK WAS ADDED BACK TO THE LEAD, AND PARAMETERS TESTED ON THE ANALYZER WERE NORMAL. HOWEVER, WHEN ATTEMPTING TO RE-CONNECT THE RA LEAD BACK INTO THE HEADER, THE PHYSICIAN WAS UNABLE TO ENGAGE THE SETSCREW. THE PHYSICIAN ATTEMPTED A NEW SETSCREW WHICH WAS ABLE TO CONNECT THE RA LEAD, BUT BEFORE PUTTING THE NEW SETSCREW INTO THE RA LEAD PORT, THE PHYSICIAN HAD PULLED THE GROMMET OUT OF THE DEVICE HEADER. DUE TO THE GROMMET BEING PULLED OFF, THE RA LEAD EXHIBITED NOISE. A NEW DEVICE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24537158 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO THE PATIENT EXPERIENCING SEPTIC SHOCK AND A HEART FAILURE EXACERBATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Heart Failure/Congestive Heart Failure; Sepsis; Septic Shock; Unspecified Infection

  MAUDE report 24309452 ↗
• InjuryJan 28, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE CRT-D FEATURE THAT MONITORS PACING AMPLITUDE THRESHOLD AND ADJUSTS RV LEAD OUTPUTS WAS PROGRAMMED OFF.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 24202645 ↗
• MalfunctionJan 20, 2026Electromagnetic Interference; Pacing Problem

  IT WAS REPORTED THAT UPON REVIEWING EPISODES, THERE APPEARED TO BE ELECTROMAGNETIC INTERFERENCE THAT CAUSED AND LED TO INHIBITION OF PACING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 24122955 ↗
• MalfunctionNov 14, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), IT WAS NOTED THAT THE PATIENT EXPERIENCED SLOW HEART RATES IN THE THIRTIES, THAT ARE BELOW THE PROGRAMMED LOWER RATE SETTING OF THE CRT-D. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 23555398 ↗
• InjuryNov 6, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE CRT-D SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION.

  Patient problems: Medical device site infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23489953 ↗
• InjurySep 17, 2025Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS AN EPISODE CLASSIFIED AS VENTRICULAR FIBRILLATION (VF) WHICH RESULTED IN THE DELIVERY OF SHOCK THERAPY. THE EPISODE WAS SUCCESSFULLY TREATED; HOWEVER, STORED ELECTROGRAMS SHOWED NON-PHYSIOLOGIC RATES AND MORPHOLOGIES CONSISTENT WITH ELECTROMAGNETIC INTERFERENCE (EMI). IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOLDING ONTO A CLOTHES WASHING MACHINE AT THE TIMEOF THE EVENT. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 23077257 ↗
• InjurySep 2, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP). SUBSEQUENTLY, THE RHYTHM ACCELERATED INTO VENTRICULAR FIBRILLATION (VF). THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 22937681 ↗
• InjuryAug 20, 2025Device Sensing Problem; Device Sensing Problem

  THE PATIENT WAS SEEN BY THEIR FOLLOWING PHYSICIAN AND IT WAS DETERMINED THAT THE SHOCK THE PATIENT RECEIVED WAS APPROPRIATE.

  Patient problems: Loss of consciousness; Shock from Patient Lead(s); Tachycardia

  MAUDE report 22851558 ↗
• MalfunctionAug 1, 2025Signal Artifact/Noise; Electromagnetic Interference; Signal Artifact/Noise; Electromagnetic Interference

  IT WAS REPORTED THAT THE TRANSMISSION REPORT SHOWED EVIDENCE OF NOISE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING AND LOW BUT STABLE PACING IMPEDANCE. ADDITIONALLY, THERE WAS A LEAD INTEGRITY ALERT (LIA) NOTED FOR HIGH RATE, NON-SUSTAINED EPISODES AND SHORT VENTRICULAR INTERVALS. THE DEVICE AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690990 ↗
• InjuryJul 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEPLETED EARLIER THAN EXPECTED. THE PATIENT NOTED THAT THEIR PHONE WAS NEXT TO THEIR DEVICE AND BELIEVED THAT THERE WAS AN INTERFERENCE THAT CAUSED THE TONE. THE PATIENT NOTED THAT THEIR DOCTOR SAID, "IT SHOULDN'T HAVE GONE OFF." THE PATIENT ALSO NOTED THAT THEY HAD CONFIRMED WITH THEIR PHYSICIAN THAT THE TONING WAS DEFINITELY DUE TO THE BATTERY RUNNING LOW. THE PATIENT ALSO REPORTED THAT THEIR ¿THIRD WIRE WAS SO MESSED UP THEY DIDN¿T KNOW WHAT TO DO WITH IT.¿ THE PATIENT NOTED THAT ONE LEAD IS PREVENTING THEM FROM DOING A MAGNETIC RESONANCE IMAGING (MRI). THE CRT-D AND LEAD REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22398893 ↗
• InjuryJul 3, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). GROSS UNDERSENSING WAS NOTED ON THE RIGHT ATRIAL (RA) LEAD. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Shock from Patient Lead(s)

  MAUDE report 22396029 ↗
• InjuryJun 30, 2025Premature Discharge of Battery; Delayed Charge Time; Premature Discharge of Battery; Delayed Charge Time

  IT WAS REPORTED THAT WITHIN A ONE WEEK TIME PERIOD, THE PATIENT RECEIVED OVER ONE HUNDRED APPROPRIATE SHOCKS FROM THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO HYPOKALEMIA. A REVIEW OF THE DEVICE DATA BY QUALIFIED PERSONNEL DETERMINED THAT THE DEVICE EXPERIENCED RAPID BATTERY DEPLETION AND REACHED END OF SERVICE (EOS) DUE TO EXCESSIVE CHARGE TIME. IN ADDITION, A LEAD INTEGRITY ALERT (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE CRTD WAS EXPLANTED AND REPLACED. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hypokalemia

  MAUDE report 22360080 ↗