Cobalt VR MRI SureScanRecalls & reported problems across all models

We found 2 models of Cobalt VR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 368 adverse event reports in the FDA's MAUDE database, received between Sep 3, 2020 and Sep 30, 2026 — classified as 8 deaths, 261 injuries, 99 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (102 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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 VR 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. Apr 16, 2024Open, Classified

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

   Z-2208-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. May 10, 2023Open, 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-1821-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. May 10, 2023Open, 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-1820-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. Jun 22, 2022Open, 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-1487-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

5. Apr 12, 2022Open, 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 ↗

Most reported Cobalt VR MRI SureScan problems

Cobalt VR MRI SureScan models

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

• Cobalt™ VR MRI SureScan™ DVPB3D4

  Pulse generator, permanent, implantable
  4 recalls6 deaths287 reports
• Cobalt™ VR MRI SureScan™ DVPB3D1

  Implantable cardioverter defibrillator (non-CRT)
  3 recalls2 deaths81 reports

Recent Cobalt VR MRI SureScan adverse event reports

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

• InjurySep 30, 2026Premature Discharge of Battery; Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951820 ↗
• InjurySep 30, 2026Premature Discharge of Battery

  It was reported that the Implantable Cardioverter Defibrillator (ICD) exhibited premature battery depletion. The device 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 50941776 ↗
• InjurySep 8, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) delivered possible inappropriate Anti-Tachycardia Pacing (ATP) and shocks for a detected Ventricular Fibrillation (VF) that was suspected to be Atrial Fibrillation (AF) with Rapid Ventricular Response. The ICD remains in use. No patient complications have been reported as a result of this event.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50674486 ↗
• InjurySep 8, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  It was reported that the device inappropriately withheld therapy for Supra Ventricular Tachycardia (SVT) during the patient's Ventricular Fibrillation (VF). The Implantable Cardioverter Defibrillator (ICD) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50668865 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619630 ↗
• MalfunctionAug 5, 2026Electromagnetic Interference; Over-Sensing

  It was reported that the patient presented to the emergency room due to tingling in their arms, chest pain, and an alarm. The patient had been hosing off their patio at the time. An interrogation of the Implantable Cardioverter Defibrillator (ICD) indicated a Lead Integrity Alert (LIA) triggered due to High Rate Non-Sustained episodes and short ventricular intervals. Review of the episodes indicated oversensing on the ventricular channel due to electromagnetic interference. The Implantable Cardioverter Defibrillator (ICD) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Paresthesia

  MAUDE report 50140449 ↗
• InjuryJun 26, 2026Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE HOSPICE PHYSICIAN STATED THAT THE PATIENT HAS A MAGNET ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE BUT IS HAVING SOME SKIN BREAKDOWN AND WOULD LIKE TO GET THE TACHY THERAPIES ON THE ICD DEVICE PROGRAMMED OFF PERMANENTLY. ADDITIONALLY, IT WAS STATED THAT THIS PARTICULAR MAGNET IS WORKING MUCH BETTER BUT THE PREVIOUS MAGNET WAS FINICKY AND THERE WAS AN ALLEGATION THAT THE DEVICE WAS ACTUALLY DISCHARGING. IT IS UNKNOWN IF MAGNET CONTACT WAS MAINTAINED AND WHETHER OR NOT THE ICD SHOCKED THE PATIENT OR IF THE ICD WAS JUST TONING PERIODICALLY. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25635526 ↗
• InjuryJun 24, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED PREMATURE BATTERY DEPLETION. THE ICD 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 25609438 ↗
• MalfunctionJun 2, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS NOT ¿WORKING OR DOING ANYTHING.¿ 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 25360814 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) 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 25233221 ↗
• InjuryMay 19, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEY SAT UP DURING THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT PROCEDURE AND "HAD AN OUT OF BODY EXPERIENCE". AFTER THE PROCEDURE, HE PATIENT EXPERIENCED SYNCOPE AND WAS TOLD BY THE PHYSICIAN THAT "SOMETHING HAD HAPPENED DURING THE IMPLANT SURGERY". THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Syncope/Fainting

  MAUDE report 25225578 ↗
• InjuryMay 19, 2026Electromagnetic Interference; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT THAT CAUTERY WAS USED AT A DERMATOLOGIST APPOINTMENT AND A MAGNET WAS NOT USED. DURING CAUTERY THE PATIENT WAS SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD 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 25225496 ↗
• InjuryMay 19, 2026Electromagnetic Interference

  IT WAS REPORTED BY THE PATIENT THAT CAUTERY WAS USED AT A DERMATOLOGIST APPOINTMENT AND A MAGNET WAS USED. DURING CAUTERY THE PATIENT WAS SHOCKED BY THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD 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 25225463 ↗
• InjuryMay 8, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED ATRIAL FIBRILLATION (AF) AND "DISCHARGED" WHEN IT SHOULD NOT HAVE. THE ICD 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 25130192 ↗
• MalfunctionMay 8, 2026Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED A FALSE POSITIVE RIGHT VENTRICULAR LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES DUE TO ELECTROMAGNETIC INTERFERENCE EXPOSURE. THE ALERT OCCURRED AT THE SAME TIME THE PATIENT APPLIED A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS) UNIT. THE RV LEAD IMPEDANCE TREND WAS CONFIRMED STABLE AND STEADY STATE. THE ICD 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 25124785 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• 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
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls