Cobalt™ DR MRI SureScan™ DDPB3D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 00763000178376), received between Sep 10, 2020 and Sep 25, 2026 — classified as 2 deaths, 83 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (32 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-1725-2023 · 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 125 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Signal Artifact/Noise; Misconnection; Over-Sensing; Pacing Problem

  It was reported that the Right Ventricular (RV) lead triggered Lead Integrity Alert (LIA) for Sensing Integrity Counter (SIC) and High Rate Non-Sustained episodes and had exhibited noise and oversensing resulting in inhibition of pacing. It was also stated that the Implantable Cardioverter Defibrillator (ICD) exhibited connection issue. A chest Xray indicated that the device and RV lead exhibited connection issue as the RV lead was not inserted past the setscrew. The Lead was reposition in device connector port and the Device and 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 50902720 ↗
• MalfunctionSep 10, 2026Inappropriate or Unexpected Reset; Reset Problem

  It was further reported that the patient had an in-office interrogation done and the device was programmed back to pre-reset parameters. The device remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718108 ↗
• MalfunctionJul 10, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 25785036 ↗
• InjuryJun 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) FOR POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE DEVICE DETECTED AS VENTRICULAR TACHYCARDIA (VT). 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 25605859 ↗
• InjuryJun 12, 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 25483924 ↗
• MalfunctionMay 29, 2026Pacing Problem; 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 ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT) TWICE. THE PATIENT ALSO EXPERIENCED CHEST PAIN. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 25340776 ↗
• InjuryMay 21, 2026Reset Problem

  IT WAS REPORTED THAT TWO DAYS AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS IMPLANTED USING THE MOBILE PROGRAMMER, THE ICD EXHIBITED A FULL ELECTRICAL RESET. THE ELECTRICAL RESET WAS REPORTED TO HAVE OCCURRED BECAUSE OF THE DEVICE FIRMWARE DETECTING AN ERROR IN THE WAVELET TEMPLATE AND DEVICE MEMORY. THE RESET WAS CLEARED AND THE DEVICE PARAMETERS WERE SET TO RESET VALUES. 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 25242332 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH SYNCOPE AROUND THE TIME OF A VENTRICULAR FIBRILLATION (VF) EVENT, WITH AN APPROPRIATE SHOCK BEING DELIVERED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 25149809 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION AND THE ORGANISM WAS REPORTED AS STAPHYLOCOCCUS AUREUS. ADDITIONALLY, THE PATIENT EXPERIENCED PURULENT DISCHARGE/PUS AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 25044931 ↗
• InjuryApr 28, 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). THE ICD DETECTED THE EPISODE AS FAST VENTRICULAR TACHYCARDIA (FVT). 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 25022900 ↗
• InjuryFeb 26, 2026High impedance; Misconnection; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED RISING AND OUT OF RANGE (OOR) HIGH PACING IMPEDANCE. IT WAS FURTHER REPORTED THAT THE PATIENT WAS BROUGHT TO THE CATHETERIZATION LAB WHERE IT WAS FOUND THAT THE RV LEAD PIN WAS NOT PAST THE SET SCREW IN THE HEADER OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE LEAD WAS REINSERTED INTO THE DEVICE. 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 24461965 ↗
• MalfunctionFeb 26, 2026Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT ISOLATED NOISE OVERSENSING WAS NOTED ON THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICD) RIGHT VENTRICULAR CHANNEL ONLY DURING IMPEDANCE TESTING. THE NOISE COULD NOT BE REPRODUCED WITH ISOMETRICS AND ARM MOVEMENTS. STABLE THRESHOLDS, IMPEDANCE AND SENSING WERE NOTED. 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 24453041 ↗
• MalfunctionJan 14, 2026Over-Sensing

  IT WAS REPORTED THAT THERE WAS A BEAT OF OVERSENSING ON THE ATRIAL CHANNEL DURING MANUAL LEAD IMPEDANCE TESTING. THE IMPLANTABLE CAR DIOVERTER 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 24069373 ↗
• MalfunctionNov 18, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD A PARTIAL RESET WHERE THE DIAGNOSTIC DATA WAS CLEARED BUT THE PROGRAMMED PARAMETERS REMAINS UNCHANGED. IT WAS FURTHER REPORTED THAT THE ICD HAD A MULTIPLE PARTIAL ELECTRICAL RESETS BEFORE HAVING FULL ELECTRICAL RESET. IT WAS NOTED THAT THE PATIENT SHOOTS RIFLES ON THE LEFT SHOULDER AND ALL THE RESETS CORRELATED TO TIMES THE PATIENT WAS SHOOTING. 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 23584005 ↗
• InjuryNov 14, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT DID RECEIVE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WHICH WAS NOTED TO BE APPROPRIATE BASED ON RATE PARAMETERS THAT WERE SET. THE PATIENT'S ARRHYTHMIA WAS TREATED WITH MEDICATION.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23556456 ↗
• InjuryNov 14, 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 ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 23555931 ↗
• InjuryNov 11, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT "AROUND 7:30AM FELT A "TINGLING, SHOCKING SENSATION" ONCE A SECOND EVERY SECOND FOR ABOUT 15-20 SECONDS. THE PATIENT HAD NO OTHER SYMPTOMS. THE PATIENT WAS REFERRED TO THE HEART DOCTOR TO DISCUSS. IT WAS FURTHER REPORTED THAT ABOUT A MONTH AFTER THE CALL, THE PATIENT HAD AN OFFICE VISIT AND THE SENSATION WAS NOT REPRODUCIBLE DURING THE INTERROGATION. THE REMAINING SUTURE WAS REMOVED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS REPROGRAMMED PER DEVICE CLINIC PROTOCOL AND 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

  MAUDE report 23525247 ↗
• InjuryNov 7, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE CRT-D HIGH VOLTAGE THERAPY AND ATP WAS APPROPRIATE.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 23496838 ↗
• InjuryNov 3, 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 A SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR AN EPISODE DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE THAT WAS SUSPECTED O BE ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF). 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 23459919 ↗
• InjurySep 19, 2025Failure to Deliver Shock/Stimulation; Device Sensing Problem; Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN RV LEAD NOISE WARNING. IN ADDITION, OVERSENSING NOISE EPISODES WERE NOTED AS WELL AS INTERMITTENT T-WAVE OVERSENSING (TWOS). THE RV LEAD HAD ALSO EXHIBITED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH-RATE NON-SUSTAINED EPISODES. AFTER FURTHER REVIEW, IT WAS DETERMINED THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) APPEARED TO SHOW THE LEAD NOISE DISCRIMINATOR WITHHOLDING THERAPY; HOWEVER, IT WAS BELIEVED THE PATIENT WAS ONLY EXPERIENCING ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE ICD AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation

  MAUDE report 23095890 ↗
• MalfunctionSep 12, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) WAS TRIGGERED DUE TO HIGH RATE NON-SUSTAINED EPISODES AND ELEVATED SENSING INTEGRITY COUNTER (SIC). IT WAS NOTED THAT THE PATIENT WAS SWIMMING IN A POOL AT THE TIME OF THE LIA. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED ELECTROMAGNETIC INTERFERENCE THAT WAS LIKELY FROM THE POOL. THE EMI RESULTED IN THE LEAD INTEGRITY ALERT (LIA). 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 23039804 ↗
• InjurySep 5, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SUPRA VENTRICULAR TACHYCARDIA (SVT) DISCRIMINATORS INAPPROPRIATELY DELAYED THERAPY DURING A VENTRICULAR TACHYCARDIA (VT) EPISODE. THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 22977867 ↗
• InjuryAug 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH PACING IMPEDANCE. THE PACING PORTION OF THE RV LEAD WAS REMOVED AND REPLACED WITH AN ATRIAL LEAD, AND THE DEVICE SYSTEM WAS UPGRADED TO A DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. BEFORE THE PROCEDURE, THE PATIENT WAS NOTED TO BE IN A SINUS RHYTHM WITH COMPLETE HEART BLOCK. THE POCKET WAS CLOSED AFTER THE PROCEDURE, AND WHEN THEY TRIED TO WAKE THE PATIENT, THE PATIENT WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS INITIATED AND THE EXTERNAL DEFIBRILLATION WAS PROVIDED. THE PATIENT STABILIZED AND WAS MONITORED OVERNIGHT. THE ICD SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 22872541 ↗
• MalfunctionAug 15, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816413 ↗
• InjuryJul 24, 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 REMOVED DUE TO INFECTION APPROXIMATELY TWO MONTHS P OST-GENERATOR REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22585475 ↗