Cobalt™ VR MRI SureScan™ DVPB3D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 81 adverse event reports that list this exact device (DI 00763000178499), received between Sep 15, 2020 and Jun 26, 2026 — classified as 2 deaths, 60 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (15 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-1820-2023 · 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-1487-2022 · 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 81 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO A POCKET INFECTION AND EROSION. THE ORGANISM WAS REPORTED AS METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Medical device site infection; Pocket Erosion

  MAUDE report 25084335 ↗
• InjuryMar 9, 2026Failure to Interrogate; Defibrillation/Stimulation Problem; Impedance Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A PARTIAL DIAGNOSTIC ELECTRICAL RESET AROUND THE SAME TIME A SHORT CIRCUIT PROTECTION (SCP) OCCURRED DURING HIGH VOLTAGE THERAPY RESULTING IN LESS THAN THE PROGRAMMED HIGH VOLTAGE ENERGY BEING DELIVERED FOR A VENTRICULAR FIBRILLATION (VF) EPISODE. IT COULD NOT BE DETERMINED IF THE SCP WAS RELATED TO THE ICD OR THE RIGHT VENTRICULAR (RV) LEAD SINCE DETAILS OF THE SHOCKS WERE UNAVAILABLE DUE TO THE ELECTRICAL RESET. IT WAS NOTED THAT THE VF EPISODE WAS NOT SUCCESSFULLY TERMINATED AND THERE WAS AN INCREASE IN RV COIL IMPEDANCE DUE TO THE SCP. THE PATIENT WAS ADMITTED AND HAD EXPERIENCED UNSTABLE VENTRICULAR TACHYCARDIA (VT) AND VF. IT WAS FURTHER REPORTED THAT THE ICD COULD NOT BE INTERROGATED VIA THE MONITOR. TROUBLESHOOTING WAS DONE AND THE ICD WAS ABLE TO BE INTERROGATED VIA NON-WIRELESS TELEMETRY. THE ICD WAS EXPLANTED AND REPLACED, AND THE RV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia; Ventricular Fibrillation

  MAUDE report 24552501 ↗
• InjuryMar 2, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AN EPISODE IN THE SUPRA VENTRICULAR TACHYCARDIA (SVT) ZONE THAT WAS SUSPECTED TO BE VENTRICULAR TACHYCARDIA (VT). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 24491255 ↗
• MalfunctionFeb 9, 2026High impedance; Misconnection; Over-Sensing

  IT WAS REPORTED THAT POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE JUMPS WITH HIGH RATE NON-SUSTAINED EPISODES AND HIGH SENSING INTEGRITY COUNTER (SIC). A CONNECTION ISSUE BETWEEN THE RV PACE/SENSE LEAD PIN AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUSPECTED. THE RV LEAD AND ICD 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 24300212 ↗
• DeathJan 28, 2026Electromagnetic Interference

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE, THAT THE PATIENT WAS DECEASED. IT WAS NOTED THAT THE PATIENT HAD TAKEN A SHOWER AND SHORTLY AFTERWARDS EXPERIENCED CARDIAC ARREST. THE CALLER INQUIRED WHETHER A MAGNETIC SHOWER HEAD COULD HAVE CONTRIBUTED TO THE PATIENT'S DEATH. INFORMATION RELATED TO ELECTROMAGNETIC INTERFERENCE (EMI) WAS DISCUSSED WITH THE CALLER. THE DISPOSITION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IS UNKNOWN. ADDITIONAL INFORMATION RELATED TO THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

  Patient problems: Cardiac Arrest

  MAUDE report 24202195 ↗
• MalfunctionOct 28, 2025Pacing Problem; Defibrillation/Stimulation Problem; Pacing Problem; Defibrillation/Stimulation Problem

  IT WAS REPORTED THAT THE PATIENT¿S RHYTHM WAS GOING IN AND OUT OF THE DETECTION ZONE, CAUSING A DELAY IN VENTRICULAR TACHYCARDIA (VT) THERAPY. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 23404514 ↗
• DeathOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT DUE TO SYNCOPE/NEAR SYNCOPE AND HEART RACING. NORMAL DEVICE FUNCTION WAS NOTED AT THAT TIME, HOWEVER THE PATIENT PASSED AWAY TWO DAYS LATER. CAUSE OF DEATH INFORMATION WAS REQUESTED BUT HAS NOT BEEN RECEIVED.

  Patient problems: Arrhythmia; Syncope/Fainting

  MAUDE report 23322652 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND HAD DEVELOPED A SCAB AT THE POCKET SITE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WHICH WAS THERE FOR A COUPLE OF WEEKS. PER THE PATIENT, WHEN THE SCAB FELL OFF THEY COULD SEE THE DEVICE. THE ICD WAS EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS PULLED, CUT, ABANDONED AND REMAINS IN THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 23291488 ↗
• InjuryAug 21, 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 POSSIBLY INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR SUPRA VE NTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 22865295 ↗
• InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LEAD VEGETATION WAS PRESENT.  THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 22774775 ↗
• MalfunctionAug 5, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT'S ELECTRIC HEDGE TRIMMER COULD HAVE CAUSE THE EXTERNAL ELECTROMAGNETIC INTERFERENCE, SINCE THE PATIENT WAS USING THE TRIMMER AT THE TIME OF THE EPISODE. 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 22716721 ↗
• InjuryJun 3, 2025Pacing Problem; Unable to Obtain Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Unable to Obtain Readings; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR FIBRILLATION (VF). THERE WAS ALSO UNSUCCESSFUL SHOCK FOR VENTRICULAR TACHYCARDIA (VT) / VF COUNTER THAT INCREMENTED EVEN THOUGH NO SHOCK THERAPY WAS DELIVERED. 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 22135543 ↗
• InjuryMay 19, 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 MULTIPLE ROUNDS OF ANTI-TACHYCARDIA PACING (ATP) AND A SHOCK FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) WHICH WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 22043939 ↗
• InjuryMay 5, 2025Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Signal Artifact/Noise; Mechanical Problem; Over-Sensing

  IT WAS REPORTED THAT POST IMPLANT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD, OVERSENSING OF NOISE WAS OBSERVED AND CAUSED INAPPROPRIATE EPISODE DETECTION. THE DEVICE WAS REPROGRAMMED, AND THE PATIENT WAS BROUGHT BACK TO THE LAB. UPON POCKET OPENING, IT WAS FOUND THAT THE DEVICE SET SCREW WAS LOOSE. THE LEAD WAS REINSERTED INTO THE HEADER, PASSED A TUG TEST, AND ALL LEAD TESTING RESULTS WERE STABLE WITH NO FURTHER NOISE. THE LEAD AND DEVICE 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 21961100 ↗
• InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXTRACTED DUE TO A BACTEREMIA INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 21470664 ↗
• InjuryJan 15, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND AN UNSUCCESSFUL SHOCK FOR 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 21158296 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION AT THE DEVICE POCKET. PURULENT DISCHARGE/PUS WAS NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 21154477 ↗
• InjuryDec 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST REVISION PROCEDURE, THE PATIENT EXPERIENCED A POCKET INFECTION WITH OOZING NOTED AT THE WOUND SITE. IT WAS ADDITIONALLY NOTED THAT AN ABSORBABLE ANTIBACTERIAL ENVELOPE HAD BEEN PLACED AT THE TIME OF THE REVISION. THE PATIENT'S INFECTION WAS LATER DIAGNOSED AS AN ESCHERICHIA COLI INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD WERE EXPLANTED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 20821381 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND THEN REPLACED A WEEK LATER DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 20195771 ↗