Cobalt™ XT DR MRI SureScan™ DDPA2D1Recalls & reported problems

Summary

The FDA's MAUDE database contains 241 adverse event reports that list this exact device (DI 00763000178338), received between Jun 17, 2021 and Sep 28, 2026 — classified as 3 deaths, 164 injuries, 74 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (72 reports).

5 FDA recall records name this device's identifier, 5 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-2209-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Dec 7, 2023Class IIOpen, Classified

   During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.

   Z-0779-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. 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-1721-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. 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 ↗

5. 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 241 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  Patient problems: Tachycardia

  MAUDE report 50916331 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

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

  MAUDE report 50903449 ↗
• InjurySep 18, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the patient was experiencing episodes of passing out. It was noted that the patient¿s condition had improved since reprogramming. 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 50813507 ↗
• InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted and replaced several days later due to an infection with redness. No further patient complications have been reported as a result of this event.

  Patient problems: Erythema; Unspecified Infection

  MAUDE report 50813388 ↗
• MalfunctionSep 17, 2026Pacing Problem

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AF) events resulting in unnecessary pacing at times and atrial events falling in blanking period.   The RA lead and Implantable Cardioverter Defibrillator (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 50804959 ↗
• InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed an infection. 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: Unspecified Infection

  MAUDE report 50756599 ↗
• InjurySep 3, 2026Capturing Problem

  Patient problems: Palpitations

  MAUDE report 50595366 ↗
• InjurySep 3, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50591240 ↗
• MalfunctionAug 28, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507325 ↗
• InjuryAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Right Ventricular (RV) lead exhibited tip to coil out of range impedance that was noted to be chronically near the lower limit, suspected to be slightly below the alert threshold. It was further reported, via follow up, no intervention was performed. It was also noted the patient had a pocket infection and sepsis. The Implantable Cardioverter Defibrillator (ICD) system remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection; Sepsis

  MAUDE report 50501081 ↗
• MalfunctionAug 27, 2026Electromagnetic Interference; Misconnection; Over-Sensing

  It was reported that the clinician noted an issue with over-sensing in the patient's defibrillator.  A review of device data indicated what appears to be possible Electromagnetic Interference source or lead/device connection issue as device was implanted less than a month prior.   The Implantable Cardioverter Defibrillator (ICD), Right Atrial (RA) lead and Right Ventricular (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 50483261 ↗
• MalfunctionAug 26, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50452478 ↗
• MalfunctionAug 20, 2026Pacing Problem; Device Sensing Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50355839 ↗
• MalfunctionAug 13, 2026Electromagnetic Interference

  It was reported that the Implantable Cardioverter Defibrillator (ICD) device exhibited 50/60 hertz Electromagnetic Interference (EMI). It was noted that the patient was swimming in a family member's pool when the EMI occurred. 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 50237535 ↗
• InjuryAug 3, 2026Signal Artifact/Noise; High impedance; Misconnection; Unstable Capture Threshold; Unstable Impedance

  It was reported that the Right Ventricular (RV) lead triggered an alert for RV Tip to Coil high impedance for a period of time, then impedance of dropped to nominal measurements per the current electrograms (EGM). It was also noticed RV threshold had dropped. The RV lead also exhibited a spike and high RV defibrillation impedance, and varying pacing impedance.   Additionally, it was noted that during a device generator change out, the physician had a difficult time seating the RV coil into the device header.  A chest X-ray was performed and physician concluded that the X-ray looked okay.  Additionally, a healthcare professional concluded nothing pertinent to patient's current status. A device check revealed RV lead, steady, solid impedance and threshold.  Pocket manipulation was performed that was unable to create noise. It was further reported that the patient was hospitalized for recurrent syncopal episodes. Review of the remote transmission showed a continuation of high pacing and RV coil impedances on the RV lead. Lead noise was visible with movement and RV coil impedance was variable since the device generator change. A lead revision was scheduled. During the procedure, it was

  Patient problems: Syncope/Fainting

  MAUDE report 50121936 ↗
• InjuryJul 29, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possible inappropriate high voltage therapy and Anti-Tachycardia Pacing for Supra Ventricular Tachycardia (SVT) detected as Ventricular Fibrillation (VF).  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 50077622 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25714021 ↗
• InjuryJun 25, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) INAPPROPRIATELY WITHHELD THERAPY FOR VENTRICULAR TACHYCARDIA (VT) DUE TO ONSET AND STABILITY. ADDITIONALLY, IT WAS NOTED THAT THE ICD HAD A PARTIAL ELECTRICAL RESET. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Tachycardia

  MAUDE report 25622247 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A CHRONIC HEMATOMA. A CAPSULECTOMY WAS PERFORMED AT THE SAME TIME AS AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). ONE MONTH POST CHANGEOUT, THE PATIENT PRESENTED WITH AN INFECTION AND AN ERODED POCKET. THE ICD SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Pocket Erosion

  MAUDE report 25511118 ↗
• MalfunctionJun 11, 2026High impedance; Mechanical Problem

  IT WAS REPORTED THAT SHORTLY AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CHANGEOUT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR HIGH UNDEFINED RV DEFIBRILLATION IMPEDANCES. A CONNECTION ISSUE WAS SUSPECTED. 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 25474673 ↗
• InjuryJun 8, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW PACING IMPEDANCE. 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 25430217 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS RELATED TO AN INFECTION. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25384862 ↗
• MalfunctionJun 3, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), THE DEVICE COULD NOT SUCCESSFULLY CONNECT WITH THE RELAY AND A REMOTE TRANSMISSION COULD NOT BE SENT.  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 25376804 ↗
• InjuryMay 28, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO A POCKET INFECTION. ADDITIONALLY, THE PATIENT EXPERIENCED SWELLING AND WOUND DEHISCENCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25321375 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST IMPLANT THE PATIENT EXPERIENCED A POCKET INFECTION WITH DISCOMFORT, PURULENT DISCHARGE/PUS, REDNESS, SWELLING, AND WOUND DEHISCENCE. THE LEADS WERE CUT, AND THE ICD WAS REMOVED. A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema; Wound Dehiscence

  MAUDE report 25246463 ↗