Cobalt™ HF CRT-D MRI SureScan™ DTPB2D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 179 adverse event reports that list this exact device (DI 00763000178215), received between Aug 21, 2020 and Sep 30, 2026 — classified as 5 deaths, 117 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (21 reports).

4 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-1782-2023 · 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-1488-2022 · 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 ↗

4. Apr 7, 2021Class IITerminated

   The device may contain a manufacturing defect of a missing resistance spot weld (RSW).

   Z-1650-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 179 reports, in the reporter's own words as published by the FDA.

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

  It was reported by the patient that the defibrillator is leaking inside the patient.  The Cardiac Resynchronization Therapy Defibrillator (CRT-D) remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50945036 ↗
• InjurySep 17, 2026Failure to Deliver Shock/Stimulation

  It was reported by a physician that the patient was in cardiac arrest.  The patient was externally shocked.  The implanted Cardiac R esynchronization Therapy Defibrillator (CRT-D) did not deliver shocks to rescue patient.  The CRT-D remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Arrest

  MAUDE report 50804343 ↗
• MalfunctionSep 4, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing triggering false Atrial Tachycardia/Atrial Fibrillation (AT/AF) detections. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) also exhibited functional undersensing due to the refractory/blanking period on the atrial channel resulting in overpacing. The 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 50607017 ↗
• InjuryAug 5, 2026Misconnection

  It was reported that by the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient that the the Right Ventricular (RV) lead had disconnected from the CRTD. The lead was explanted and replaced and 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 50149840 ↗
• InjuryJun 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. IT WAS NOTED THAT THE PATIENT EXPERIENCED SEPSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 25418018 ↗
• MalfunctionMay 21, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODES DETECTED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AS VENTRICULAR FIBRILLATION (VF). THE CRT-D 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 25250377 ↗
• InjuryMay 18, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE CRT-D DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). THE CRT-D 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 25210858 ↗
• MalfunctionMay 12, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PALPITATIONS. IT WAS NOTED THAT THERE WAS RIGHT ATRIAL (RA) LEAD UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENTS IN PROGRESS AND INAPPROPRIATE ATRIAL PACING. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POSSIBLY DETECTED AT/AF WITH RAPID VENTRICULAR RESPONSE/SUPRA VENTRICULAR TACHYCARDIA (SVT) AS MONITORED VENTRICULAR TACHYCARDIA (VT). THE RA AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153288 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25144991 ↗
• InjuryMay 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25100813 ↗
• MalfunctionApr 1, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY A CLINICIAN THAT THERE WAS A SUSPECTED CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MALFUNCTION. THE CRT-D 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 24760459 ↗
• MalfunctionMar 30, 2026Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE RV LEAD ALSO EXHIBITED OVERSENSING. IN ADDITION, NOISE WAS NOTED ON BOTH THE RV AND RIGHT ATRIAL (RA) ELECTROGRAMS (EGM). IT WAS FURTHER CONFIRMED THAT THE PATIENT WAS USING A TRANSCUTANEOUS ELECTRICAL NERVE STIMULATION (TENS) UNIT AT THE TIME OF THE LIA AND NOISE/OVERSENSING EPISODES. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED ELECTROMAGNETIC INTERFERENCE (EMI). THE CRT-D 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 24729970 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. WOUND DEHISCENCE WAS NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Wound Dehiscence

  MAUDE report 24715227 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION WITH THE ORGANISM IDENTIFIED AS ENTEROCOCCUS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Endocarditis

  MAUDE report 24547563 ↗
• InjuryFeb 4, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT COMPLAINED OF THE "DEVICE BUZZING". THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 24260200 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT EXPERIENCED A LARGE HEMATOMA AND THEN A POCKET INFECTION. THE PATIENT ALSO EXPERIENCED DISCOMFORT, PURULENT DISCHARGE OR PUS, REDNESS AND SWELLING. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Hematoma; Medical device site infection; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 23707237 ↗
• MalfunctionNov 6, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED CHRONICALLY HIGH THRESHOLD MEASUREMENTS. THE LEAD WAS CAPPED AND REPL ACED. DURING THE REPLACEMENT PROCEDURE, THE PHYSICIAN COULD NOT ENGAGE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SETSCREW. IT WAS NOTED THAT THE PHYSICIAN COULD NOT RE-ENGAGE THE SETSCREW. THE DEVICE WAS NOT USED, AND ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23491112 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE SYSTEM WAS REMOVED AND REPLACED WITH A LEADLESS PACEMAKER DUE TO POCKET EROSION. THERE WAS ERYTHEMA AND SWELLING NEAR THE POCKET. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Inflammation; Pocket Erosion

  MAUDE report 23464269 ↗
• InjuryOct 31, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD PREMATURE BATTERY DEPLETION. IN ADDITION, IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD HAD HIGH THRESHOLDS. THE DEVICE WAS EXPLANTED AND REPLACED, WHILE THE 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 23439268 ↗
• InjuryOct 27, 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 INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH-VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) VERSUS ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) AND THE PATIENT WAS HOSPITALIZED. MEDICATION MANAGEMENT WAS PERFORMED FOR THE PATIENT'S UNDERLYING CONDITION AND ARRHYTHMIA. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD INCREASED ANXIETY WITH DIFFICULTY SLEEPING SINCE THE SHOCKS. THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Anxiety; Shock from Patient Lead(s); Sleep Dysfunction

  MAUDE report 23392234 ↗
• InjuryOct 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST IMPLANT THE PATIENT EXPERIENCED DISCOMFORT, PURULENT DISCHARGE/PUS, AND SWELLING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 23384120 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO INFECTION. IN ADDITION, VEGETATION WAS OBSERVED ON THE RIGHT ATRIAL (RA) LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23360556 ↗
• InjurySep 16, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (A TP) AND SHOCKED FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED 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 23064878 ↗
• MalfunctionSep 3, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR THE DETECTION OF SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT WAS CLASSIFIED AS VENTRICULAR TACHYCARDIA (VT). 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 22954968 ↗
• InjuryAug 25, 2025Inappropriate/Inadequate Shock/Stimulation; Protective Measures Problem; Inappropriate/Inadequate Shock/Stimulation; Protective Measures Problem

  IT WAS REPORTED BY THE PATIENT'S RELATIVE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS SOUNDING THE MAGNET TONE WHEN THERE WAS NO MAGNET. THEY ALSO REPORTED THAT THERE HAD BEEN SOME PROBLEMS WITH THE LEADS, AND THE CRT-D DELIVERED MULTIPLE INAPPROPRIATE SHOCKS. THE CRT-D SYSTEM 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 22888877 ↗