Cobalt HF CRT-D MRI SureScanRecalls & reported problems across all models

We found 2 models of Cobalt HF CRT-D MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 357 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2020 and Sep 30, 2026 — classified as 8 deaths, 241 injuries, 108 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (44 reports).

5 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cobalt HF CRT-D MRI SureScan recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-1782-2023 · Root cause: Under Investigation by firm · 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-1781-2023 · 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-1488-2022 · Root cause: Device Design · names 2 of these models · 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 · names 2 of these models · Recall details · FDA record ↗

5. Apr 7, 2021Class IITerminated

   The device may contain a manufacturing defect of a missing resistance spot weld (RSW).

   Z-1650-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported Cobalt HF CRT-D MRI SureScan problems

Cobalt HF CRT-D MRI SureScan models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cobalt™ HF CRT-D MRI SureScan™ DTPB2D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls5 deaths179 reports
• Cobalt™ HF CRT-D MRI SureScan™ DTPB2D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls3 deaths178 reports

Recent Cobalt HF CRT-D MRI SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Appropriate Device Problem Term/Code Not Available

  It was reported by the patient that the defibrillator is leaking inside the patient.  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: Insufficient Information

  MAUDE report 50945036 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Erosion; Medical device site infection

  MAUDE report 50939941 ↗
• InjurySep 17, 2026Failure to Deliver Shock/Stimulation

  It was reported by a physician that the patient was in cardiac arrest.  The patient was externally shocked.  The implanted Cardiac R esynchronization Therapy Defibrillator (CRT-D) did not deliver shocks to rescue patient.  The CRT-D remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Arrest

  MAUDE report 50804343 ↗
• MalfunctionSep 4, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) also exhibited functional undersensing due to the refractory/blanking period on the atrial channel resulting in overpacing. The lead 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 50607017 ↗
• 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 ↗
• InjuryAug 5, 2026Misconnection

  It was reported that by the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient that the the Right Ventricular (RV) lead had disconnected from the CRTD. The lead was explanted and replaced and 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 50149840 ↗
• InjuryJun 5, 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. IT WAS NOTED THAT THE PATIENT EXPERIENCED SEPSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25418018 ↗
• 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 ↗
• MalfunctionMay 21, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR FIBRILLATION (VF). 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 25250377 ↗
• InjuryMay 18, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE CRT-D DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). THE CRT-D 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 25210858 ↗
• 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 ↗
• MalfunctionMay 12, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PALPITATIONS. IT WAS NOTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND INAPPROPRIATE ATRIAL PACING. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DETECTED AT/AF WITH RAPID VENTRICULAR RESPONSE/SUPRA VENTRICULAR TACHYCARDIA (SVT) AS MONITORED VENTRICULAR TACHYCARDIA (VT). THE RA AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153288 ↗
• InjuryMay 11, 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 25144991 ↗
• 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 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
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• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
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