Cobalt™ XT VR MRI SureScan™ DVPA2D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 00763000178451), received between Feb 25, 2021 and Sep 30, 2026 — classified as 3 deaths, 44 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (17 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-1818-2023 · 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-1485-2022 · 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 68 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951526 ↗
• MalfunctionSep 23, 2026Defibrillation/Stimulation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872063 ↗
• MalfunctionSep 2, 2026Migration or Expulsion of Device

  It was reported by the Implantable Cardioverter Defibrillator (ICD) patient that their device was making them feel tired, fatigue and was causing discomfort. The discomfort that the patient experience was that the device felt big, uncomfortable and that the device was moving around in the pocket especially at night and would hurt.  The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Fatigue; Pain

  MAUDE report 50568820 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced a systemic infection with fever. The patient was hospitalized and the device system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Fever; Unspecified Infection

  MAUDE report 50530969 ↗
• MalfunctionAug 20, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50354367 ↗
• MalfunctionMay 22, 2026Under-Sensing; Device Sensing Problem

  IT WAS REPORTED THAT THERE WAS UNDERSENSING POST PREMATURE VENTRICULAR CONTRACTIONS (PVC) DUE TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FEATURE THAT AUTOMATICALLY ADJUSTS RIGHT VENTRICULAR (RV) LEAD SENSITIVITY. 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 25256205 ↗
• MalfunctionApr 7, 2026Electrical /Electronic Property Problem; Reset Problem

  IT WAS REPORTED THAT DURING DEVICE IMPLANTATION, THE PHYSICIAN "FLICKED THE DEVICE TO RELEASE THE SET SCREW". FOLLOWING THIS ACTION, THE DEVICE EXHIBITED A RESET; HOWEVER, IT WAS NOT CLARIFIED WHETHER THE RESET WAS DIAGNOSTIC OR A POWER-ON RESET. SUBSEQUENTLY, THE DEVICE DISPLAYED A GRAY BAR ON THE SCREEN. THE DEVICE HAD BEEN PLACED INTO THE POCKET; HOWEVER LATER THE PHYSICIAN ELECTED TO USE A DIFFERENT DEVICE FOR IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24803495 ↗
• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. DURING THE PROCEDURE; AFTER REMOVAL OF THE ANTERIOR EPICARDIAL RIGHT VENTRICULAR (RV) PATCH LEAD, THE PHYSICIAN HAD TO CLOSE A HOLE LEFT BY THE RV ANTERIOR PATCH LEAD. THE OTHER EPICARDIAL LEFT VENTRICULAR (LV) PATCH LEAD REMAINS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24627436 ↗
• InjuryMar 3, 2026Appropriate Device Problem Term/Code Not Available

  FOLLOW UP WITH THE CLINIC INDICATED THAT THE FAINTING WAS NOT RELATED TO A PRODUCT PERFORMANCE ISSUE. IT WAS NOTED THE PATIENT HAD AN ARRHYTHMIA. NO FURTHER ACTIONS WERE TAKEN.

  Patient problems: Syncope/Fainting

  MAUDE report 24497686 ↗
• InjuryFeb 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR). THE ICD DETECTED THE EPISODE 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 24412659 ↗
• InjuryFeb 16, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING AND MULTIPLE SHOCKS FOR VENTRICULAR FIBRILLATION (VF) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 24349850 ↗
• MalfunctionFeb 6, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A CONNECTOR ISSUE AND COULD NOT ENGAGE WITH THE SETSCREW. THE ICD WAS NOT IMPLANTED AND A DIFFERENT ICD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279530 ↗
• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STAPHYLOCOCCUS AUREUS INFECTION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection

  MAUDE report 24251320 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE WEEK POST AN RIGHT VENTRICULAR (RV) LEAD REPLACEMENT, 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 24039379 ↗
• MalfunctionDec 12, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH RATE NON-SUSTAINED (HRNS) AND SENSING INTEGRITY COUNTER (SIC) WITH FOUR HUNDRED AND SEVEN SHORT V-V INTERVALS. IT WAS FURTHER REPORTED THAT THE LEAD EXHIBITED A SHARP INCREASE IN THRESHOLD AND SHARP DECREASE IN R-WAVE AMPLITUDE IN ADDITION TO UNDERSENSING DURING VENTRICULAR. IT WAS SUBSEQUENTLY REPORTED THAT OVERSENSING ELECTROMAGNETIC INTERFERENCE (EMI) ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS OBSERVED DUE TO A LEFT VENTRICULAR ASSIST DEVICE (LVAD) WHICH ALSO TRIGGERED A LIA. THE RV LEAD WAS PREVIOUSLY REPROGRAMMED AND REMAINS IN USE AND 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 23791467 ↗
• InjuryDec 2, 2025Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset; Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED A PARTIAL ELECTRICAL RESET. APPROXIMATELY ONE WEEK LATER, DURING A PATIENT SKIN GRAFT PROCEDURE, THE PATIENT RECEIVED INAPPROPRIATE SHOCKS DUE TO THE USE OF CAUTERY DIRECTLY OVER THE DEVICE. A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SENSING INTEGRITY COUNTER (SIC), AND THERE WAS OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD RESULTING IN MISCLASSIFICATION OF EPISODES. IN ADDITION, THERE WAS A SLIGHT DECREASE IN THE RV LEAD IMPEDANCES. THE ICD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23693880 ↗
• InjuryNov 21, 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. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23621747 ↗
• InjuryNov 13, 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) PATIENT EXPERIENCED AN INFECTION AS THERE WAS A FOREIGN BODY GRANULOMA ON THE COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. THE DEVICE SYSTEM WAS EXPLANTED AND LATER REPLACED.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Granuloma; Unspecified Infection

  MAUDE report 23548988 ↗
• InjuryOct 24, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DETECTED AS VENTRICULAR FIBRILLATION (VF) DUE TO THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR ( ICD) FEATURE THAT OVERRIDES SVT DISCRIMINATION FOR ANY VENTRICULAR TACHYARRHYTHMIA THAT CONTINUES BEYOND A PROGRAMMED LENGTH OF TIME. 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 23380524 ↗
• DeathOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT¿S FAMILY MEMBER THAT THE PATIENT HAD THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXPLANTED APPROXIMATELY 5 WEEKS POST IMPLANT BECAUSE THE PATIENT¿S BODY WAS "REJECTING" THE ICD SYSTEM. THE PATIENT¿S FAMILY MEMBER DESCRIBED THE INFECTION AS THE WHOLE AREA WAS INFECTED, GROSS LOOKING, AND TURNING BLACK. THEY ALSO NOTED THAT THE INFECTION WAS IN THE PATIENT¿S BLOOD STREAM BUT THE PATIENT ALSO HAD AN INFECTION POSSIBLE PRIOR TO DEVELOPING THE DEVICE RELATED INFECTION. ADDITIONALLY, THE PATIENT¿S FAMILY MEMBER STATED THAT THE PATIENT IS DECEASED AND HAD PASSED AWAY ON (B)(6)2025, WHICH WAS APPROXIMATELY 6 WEEKS POST EXPLANT OF THE PATIENT¿S ICD SYSTEM. THE PATIENT¿S CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

  Patient problems: Insufficient Information; Unspecified Infection

  MAUDE report 23322417 ↗
• InjuryJul 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT FIVE DAYS POST IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO INFECTION. THE PATIENT EXPERIENCED PAIN, REDNESS, SWELLING, DISCOMFORT AND FEVER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Fever; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 22552118 ↗
• InjuryJul 16, 2025Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

  IT WAS REPORTED THAT POST-IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IMPLANT, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH DEFIBRILLATION AND PACING IMPEDANCE. AN X-RAY WAS PERFORMED AND IT APPEARED THAT THE LEAD PIN CAME BACK SLIGHTLY IN THE HEADER. THE PHYSICIAN RE-OPENED THE POCKET, REMOVED THE DEVICE AND PERFORMED THE TUG TEST AND NOTED THAT THE CONNECTION WAS LOOSE. THE LEAD WAS REINSERTED INTO THE HEADER AND THE SETSCREW WAS TIGHTENED. THE LEAD MEASUREMENTS WERE THEN NORMAL. THE ICD AND RV 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 22522438 ↗
• InjuryJul 2, 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 ANTIARRHYTHMIC PACING THERAPY AND A SHOCK FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT 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 22383462 ↗
• InjuryJun 18, 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 REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS INACTIVATED AND REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) FOR UNKNOWN REASONS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 22284369 ↗
• InjuryJun 2, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22125156 ↗