Cobalt™ VR MRI SureScan™ DVPB3D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 00763000178512), received between Sep 3, 2020 and Sep 30, 2026 — classified as 6 deaths, 201 injuries, 80 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (88 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-2208-2024 · 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-1821-2023 · 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-1487-2022 · 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 287 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 1, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED APPROXIMATELY FOUR WEEKS AFTER IMPLANT. THE REASON FOR EXPLANT IS UNKNOWN. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059989 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTION OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. IT WAS ALSO REPORTED THAT THE MICROORGANISM RESPONSIBLE FOR THE INFECTION WAS STAPHYLOCOCCUS AUREUS, THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 25032241 ↗
• InjuryApr 2, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OFTHIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24766522 ↗
• InjuryMar 30, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 24728784 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED . NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24562854 ↗
• MalfunctionMar 6, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE EXHIBITED EXTERNAL ELECTROMAGNETIC INTERFERENCE. 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 24531848 ↗
• InjuryMar 4, 2026Signal Artifact/Noise; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD PROBLEMS BECAUSE PART OF THE RIGHT VENTRICULAR (RV) LEAD WAS STUCK INSIDE. IT WAS ALSO NOTED THAT THE PIN OF THE LEAD HAD CAME OFF. A DIFFERENT DEVICE WAS SUCCESSFULLY IMPLANTED AND THE LEAD WAS CAPPED AND REPLACED. IT WAS FURTHER REPORTED BY THE PATIENT THAT THEY HAD INITIALLY HEARD ALERT TONES AND DIDN¿T REALIZE THEY WERE COMING FROM THEIR IMPLANTED DEVICE. THE PATIENT REPORTED THAT WHEN THEY WERE OUT OF STATE, THEY RECEIVED A SHOCK AND THEN AFTER THAT, IF THEY MOVED THEIR NECK A CERTAIN WAY, THEY GOT MORE SHOCKS, RECEIVING FOUR MORE. ONCE BACK HOME, THE PATIENT SAW THEIR HEART DOCTOR AND WAS TOLD THERE WAS NOISE ON THE ICD AND IT NEEDED TO BE REPLACED. WHEN REPLACING THE DEVICE, THE SURGERY TOOK LONGER AS THE DOCTOR SAID A LEAD WAS CORRODED AND WAS BROKE IN HALF. LATER THAT EVENING, A LEAD CAME LOOSE FROM THE NEW ICD POST-SURGERY, AND THE PATIENT HAD SURGERY THE FOLLOWING MORNING TO REATTACH THE LEAD. THE PATIENT SAID THE INTRAVENOUS (IV) PLACED HAD AN OCCLUSION AND THEY WERE NEVER ¿OUT¿ FOR THE SURGERY. THE PATIENT STATED THEY GOT A BLOOD CLOT AND WERE ON MEDICATION FOR I

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24511473 ↗
• InjuryMar 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT THE PATIENT AS ON LIFE SUPPORT WITH SEVERE SEPTIC SHOCK AND ORGAN FAILURE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Multiple Organ Dysfunction Syndrome; Septic Shock

  MAUDE report 24495687 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO AN INFECTION WITH REDNESS AND PAIN AT THE DEVICE SITE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Pain; Unspecified Infection

  MAUDE report 24431437 ↗
• InjuryFeb 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS BACTEREMIA. THE SOURCE OF THE INFECTION WAS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Unspecified Infection

  MAUDE report 24279556 ↗
• InjuryFeb 5, 2026Pacing Problem; Defibrillation/Stimulation Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AND IT WAS DETERMINED THAT THEY RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR FIBRILLATION (VF) AND THE PATIENT EXPERIENCED CHEST PAIN AND DISCOMFORT FROM THE HIGH VOLTAGE THERAPY. REVIEW OF AVAILABLE DEVICE AND EPISODE DATA SHOWED AN ALERT INDICATING THAT SHORT CIRCUIT PROTECTION (SCP) WAS TRIGGERED DURING THE HIGH-VOLTAGE THERAPY DELIVERY RESULTING IN LESS THAN THE PROGRAMMED HIGH-VOLTAGE ENERGY BEING DELIVERED. IT WAS ALSO NOTED THAT MULTIPLE DIAGNOSTIC ELECTRICAL RESETS TRIGGERED DURING THE VF HIGH VOLTAGE THERAPY DELIVERY. ADDITIONALLY, IT WAS NOTED THAT THE DISPLAYED DATA APPEARS TO BE INCORRECT BECAUSE OF STALE DATA, WHICH IS THE RESULT OF AN ERROR IN SOFTWARE'S PROCESSING OF THE HIGH VOLTAGE MEASUREMENTS. THE PATIENT WAS HOSPITALIZED AND THE ICD WAS REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Chest Pain; Discomfort; Shock from Patient Lead(s)

  MAUDE report 24269307 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Purulent Discharge

  MAUDE report 24039962 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE POCKET REVISION WAS FOR A HEMATOMA EVACUATION OF THE POCKET. THE RV LEAD IMPEDANCE WARNING WAS DUE TO A HIGH IMPEDANCE MEASUREMENT FROM THE ICD ERODING OUT OF THE POCKET. THE ICD HAD COMPLETELY COME OUT OF THE POCKET.

  Patient problems: Erosion; Hematoma; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 23994900 ↗
• InjuryJan 6, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED VIA THE FOLLOWING CLINIC THAT THE PATIENT WAS HOSPITALIZED, AND IT WAS CONFIRMED THAT THE ICD DELIVERED INAPPROPRIATE SHOCK FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE PATIENT ALSO EXPERIENCED PAIN AND CONFUSION. THE ICD WAS REPROGRAMMED, AND THE PATIENT¿S MEDICATION WAS ADJUSTED.

  Patient problems: Confusion/ Disorientation; Dizziness; Pain; Presyncope; Shock from Patient Lead(s)

  MAUDE report 23972801 ↗
• MalfunctionDec 23, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECTED AS VENTRICULAR FIBRILLATION (VF). 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 23879822 ↗
• MalfunctionDec 23, 2025Over-Sensing; Over-Sensing

  IT WAS REPORTED THAT OVERSENSING WAS OBSERVED DURING MANUAL IMPEDANCE TESTING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 23878858 ↗