Cobalt™ XT HF CRT-D MRI SureScan™ DTPA2D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 249 adverse event reports that list this exact device (DI 00763000178147), received between Mar 3, 2021 and Sep 29, 2026 — classified as 8 deaths, 168 injuries, 73 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (32 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-2191-2024 · 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-1774-2023 · 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-1486-2022 · 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 249 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935474 ↗
• InjurySep 23, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that high-voltage therapy was delivered in the Ventricular Fibrillation (VF) zone for a possible dual-arrhythmia that may have been Atrial Fibrillation (AF) with Fast Ventricular Rates. It was also noted that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) resulting in unnecessary pacing at times causing pre-termination in AT/AF in progress. Additionally, the Right Ventricular (RV) lead exhibited undersensing resulting in unnecessary ventricular pacing at times. The Implantable Cardioverter Defibrillator (ICD), Right Atrial (RA) lead and Right Ventricular (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 50871235 ↗
• MalfunctionSep 16, 2026Signal Artifact/Noise; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794129 ↗
• InjurySep 9, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50697571 ↗
• MalfunctionSep 3, 2026Mechanical Problem; Misconnection; Damaged Thread

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50593937 ↗
• InjurySep 3, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possibly inappropriate high-voltage therapy for Atrial Tachycardia/Atrial Fibrillation (AT/AF) with Rapid Ventricular Response that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) detected as Ventricular Fibrillation (VF). It was also noted that a AT/AF with Fast Ventricular Response or Supra Ventricular Tachycardia (SVT) or Ventricular Tachycardia (VT) episode was misclassified as a monitored High Rate Non-Sustained episode. 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 50590953 ↗
• MalfunctionSep 3, 2026Device Alarm System; Signal Artifact/Noise; Electromagnetic Interference; Over-Sensing

  It was reported that while the patient was using a corded hedge trimmer, the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device exhibited noise, oversensing on both the right atrial and right ventricle channels, and 60 hertz Electromagnetic Interference. The patient expressed frustration that there were no alerts triggered while they were using the corded hedge trimmer. 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 50588208 ↗
• MalfunctionAug 31, 2026Data Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) device was programmed at implant to provide a secondary lower heart rate level for night hours at 50 beats per minute (BPM) versus daytime rate of 70 BPM.  At implant the vendor representative did not change the device clock to Eastern standard time (EST) causing the patient to be symptomatic and had to report to the Emergency Department (ED) for care. The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Insufficient Information

  MAUDE report 50533637 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to pocket infection. No further patient complications have been reported as a result of this event..

  Patient problems: Medical device site infection

  MAUDE report 50487564 ↗
• MalfunctionAug 24, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50421476 ↗
• InjuryAug 13, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) may have inappropriately classified Ventricular Tachycardia (VT) episodes as Supra Ventricular Tachycardia (SVT) and delayed therapy due to stability and onset discriminators. It was also reported that there was Right Ventricular (RV) lead oversensing and undersensing observed which may have resulted in over pacing and delayed episode detection at times. A Lead Integrity Alert (LIA) triggered for the RV lead due to High Rate Non-Sustained episodes and elevated Sensing Integrity Counter (SIC). The CRT-D and RV lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50237815 ↗
• InjuryJun 24, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE SHOCKS AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). 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: Shock from Patient Lead(s)

  MAUDE report 25613016 ↗
• InjuryJun 24, 2026Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THERAPY WAS DELAYED FOR VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) DUE TO THE ATRIAL FIBRILLATION (AF)/AFLUTTER DISCRIMINATOR. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE CRT-D 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 25611574 ↗
• InjuryJun 1, 2026Failure to Deliver Shock/Stimulation

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT WAS HOSPITALIZED DUE TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FAILING TO PROVIDE THERAPY DURING AN EPISODE. THEY MENTIONED THAT THE PATIENT REQUIRED EXTERNAL SHOCK AND AFTERWARDS THEIR HEART RATE AND BLOOD PRESSURE BECAME ERRATIC. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia

  MAUDE report 25350066 ↗
• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT EXPERIENCED AN INFECTION WITH VEGETATION NOTED IN THE RIGHT ATRIUM AND TRICUSPID VALVE. THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND THE REMAINDER OF THE SYSTEM REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 25219063 ↗
• InjuryMay 11, 2026Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT OVERSENSING WAS OBSERVED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DURING A RADIOFREQUENCY ABLATION (RFA) PROCEDURE THAT WAS DONE WITHOUT DEVICE MANAGEMENT. THE OVERSENSING RESULTED IN INAPPROPRIATE HIGH VOLTAGE THERAPY AND A LEAD INTEGRITY ALERT (LIA) FOR ELEVATED SENSING INTEGRITY COUNTER (SIC) AND HIGH RATE NON-SUSTAINED EPISODES. THE CRT-D REMAINS 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 25142223 ↗
• MalfunctionMay 8, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN CONNECTING THE RIGHT VENTRICULAR (RV) LEAD INTO THE RV PORT OF THE CARDIAC R ESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THERE WAS A CONNECTOR ISSUE AND THE SET SCREW COULD NOT BE ENGAGED. THE CRT-D WAS NOT IMPLANTED AND A DIFFERENT CRT-D WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123833 ↗
• MalfunctionMay 7, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) EPICARDIAL LEADS EXHIBITED LOSS OF CAPTURE ON THE CURRENT ELECTROGRAMS (EGM), OVERSENSING WITH SENSED EVENTS NOTED POST VENTRICULAR BLANKING, AND OVERSENSING OF NOISE RESULTING IN INHIBITION OF PACING. IT WAS NOTED THAT THE PATIENT HAD AN ALTERED MENTAL STATUS AND WAS UNRESPONSIVE. IT WAS FURTHER REPORTED THAT APPROXIMATELY A MONTH PRIOR, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED ELECTROMAGNETIC INTERFERENCE FROM AN EXTERNAL, UNKNOWN SOURCE. THE CRT-D REMAINS IN USE. THE CRT-D AND RV EPICARDIAL LEADS REMAINS 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 25116105 ↗
• InjuryApr 28, 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 AND PATIENT DICOMFORT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 25016361 ↗
• MalfunctionApr 27, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A CONNECTOR ISSUE AND THE SETSCREW DISENGAGED FROM THE THREADS. THE CRT-D WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000436 ↗
• MalfunctionApr 24, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE MISDETECTED SUPRA VENTRICULAR TACHYCARDIA (SVT) 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 24984133 ↗
• InjuryApr 16, 2026Signal Artifact/Noise; Over-Sensing; Device-Device Incompatibility

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED ASYNCHRONOUS WITH TACHYCARDIA DETECTION OFF DUE TO OVERSENSING OF NOISE FROM THE PATIENT¿S LEFT VENTRICULAR ASSIST DEVICE (LVAD). 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 24905210 ↗
• MalfunctionApr 16, 2026Communication or Transmission Problem; Reset Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHEN THE PHYSICIAN WAS CONNECTING THE LEADS TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MANY IMPEDANCES WERE BEING RAN. TELEMETRY WAS SUDDENLY LOST AND WHEN TELEMETRY RESUMED AN AUDIBLE ALERT WAS HEART AND A NOTIFICATION APPEARED THAT A RESET OCCURRED. PARAMETERS WERE UNCHANGED; HOWEVER, THE BATTERY GAUGE WAS GREY WHEN IT HAD PREVIOUSLY BEEN GREEN AND THERE WAS NOT REPORTED BATTERY VOLTAGE AVAILABLE. A DIFFERENT 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 24897690 ↗
• InjuryApr 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) POCKET HAD WOUND DEHISCENCE AND WAS OOZING WITH PUS. THE PATIENT EXPERIENCED INFECTION, DISCOMFORT, EROSION, REDNESS AND SWELLING. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A TEMPORARY EXTERNAL IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM SO THE PATIENT COULD RECOVER FROM THE INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pocket Erosion; Purulent Discharge; Wound Dehiscence

  MAUDE report 24837934 ↗
• InjuryApr 6, 2026Mechanical Problem; Capturing Problem; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT APPROXIMATELY NINE DAYS AFTER A DEVICE EXCHANGE , THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED RISING THRESHOLDS AND PACING IMPEDANCE. ADDITIONALLY, THE RV LEAD TRIGGERED AN ALERT FOR HIGH THRESHOLDS. A CONNECTION ISSUE WAS SUSPECTED AND THE PATIENT WAS BROUGHT IN OR EVALUATION. UPON OPENING THE POCKET, IT WAS NOTED THAT THE LEAD CONNECTOR PIN WAS NOT FULLY SEATED INTO THE HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). DURING THE REVISION, IT WAS NOTED THAT THERE WAS CALCIFICATION IN THE HEADER OF THE DEVICE AND ON THE LEAD CONNECTOR PIN THAT PREVENTED THE LEAD FROM BEING DEEPLY SEATED IN THE HEADER OF THE DEVICE. THE CONNECTION WAS REVISED AND THE CRT-D 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 24794620 ↗