Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2Q1Recalls & reported problems

Summary

The FDA's MAUDE database contains 194 adverse event reports that list this exact device (DI 00763000178109), received between Mar 30, 2021 and Sep 29, 2026 — classified as 7 deaths, 124 injuries, 63 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (34 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-2193-2024 · 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-1778-2023 · 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 194 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to an infection resulting in discomfort, erosion, redness, swelling and wound dehiscence. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Erosion; Erythema; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 50934505 ↗
• MalfunctionSep 3, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50595267 ↗
• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient developed a pocket infection approximately one month post-Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant. The patient had also experienced purulent discharge/pus, redness and swelling. The organism was identified as Staphylococcus aureus. The CRT-D system was removed and a leadless pacemaker was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema

  MAUDE report 50530195 ↗
• MalfunctionAug 6, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161633 ↗
• InjuryAug 5, 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 pocket infection and discomfort. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Unspecified Infection

  MAUDE report 50147918 ↗
• MalfunctionAug 3, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50118148 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient experienced a Methicillin-resistant Staphylococcus aureus infection with vegetation on the leads.  The device system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Drug Resistant Bacterial Infection; Medical device site infection; Unspecified Infection

  MAUDE report 50085402 ↗
• InjuryJul 29, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the "device quit working and patient almost died". The Cardiac Resynchronization Therapy Defibrillator (CRT-D) remains in use. No 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 50074686 ↗
• InjuryJul 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCAR DIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE (RVR) 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 25781669 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 25394276 ↗
• MalfunctionMay 22, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD EXHIBITED INCREASED TO HIGH CAPTURE CAPTURE THRESHOLDS. IN ADDITION, STORED EPISODES SHOWED NOISE ON THE RIGHT ATRIAL (RA) LEAD. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED VIA FOLLOW UP THAT THE RA LEAD NOISE WAS DUE TO ELECTROMAGNETIC INTERFERENCE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE CRT-D REMAINS IN USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25260966 ↗
• InjuryMay 22, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM CONSISTING OF S AID DEVICE, A RIGHT VENTRICULAR (RV) LEAD WHOSE DEFIBRILLATION PORTION WAS CONNECTED BUT WHOSE PACE/SENSE PORTION WAS NOT UTILIZED , A LEAD IN THE LEFT BUNDLE BRANCH (LBB) THAT WAS CONNECTED FOR RV PACE/SENSE CAPACITY, AND A LEFT VENTRICULAR (LV) LEAD. AFTER THE CRT-D WAS PLACED IN THE POCKET, NOISE WAS BEING SENSED. THE POCKET WAS RE-OPENED AND THE LEADS WERE DISCONNECTED AND RECONNECTED BUT THE NOISE CONTINUED. THE CRT-D WAS REPLACED. THE NOISE CONTINUED ON THE NEW CRT-D. THE PHYSICIAN OPTED TO PUT THE LBB LEAD PREVIOUSLY BEING USED FOR RV PACE/SENSE CAPACITY INTO THE CRT-D'S ATRIAL PORT. THE SYSTEM 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 25260099 ↗
• MalfunctionMay 22, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM CONSISTING OF S AID DEVICE, A RIGHT VENTRICULAR (RV) LEAD WHOSE DEFIBRILLATION PORTION WAS CONNECTED BUT WHOSE PACE/SENSE PORTION WAS NOT UTILIZED , A LEAD IN THE LEFT BUNDLE BRANCH (LBB) THAT WAS CONNECTED FOR RV PACE/SENSE CAPACITY, AND A LEFT VENTRICULAR (LV) LEAD. AFTER THE CRT-D WAS PLACED IN THE POCKET, NOISE WAS BEING SENSED. THE POCKET WAS RE-OPENED AND THE LEADS WERE DISCONNECTED AND RECONNECTED BUT THE NOISE CONTINUED. THE CRT-D WAS REPLACED. THE NOISE CONTINUED ON THE NEW CRT-D. THE PHYSICIAN OPTED TO PUT THE LBB LEAD PREVIOUSLY BEING USED FOR RV PACE/SENSE CAPACITY INTO THE CRT-D'S ATRIAL PORT. THE SYSTEM 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 25259922 ↗
• InjuryMay 13, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING WITH NO OBSERVED IMPACT TO OVERALL DEVICE FUNCTION OR PE RFORMANCE. THE RV LEAD REMAINS IN USE. IT WAS ALSO REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE THERAPY AND ANTI-TACHYCARDIA PACING (ATP) FOR SUSPECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR TACHYCA RDIA (VT). 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 25163215 ↗
• DeathMay 12, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PASSED AWAY BECAUSE THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOCKED THEM. NO FURTHER INFORMATION COULD OBTAINED THROUGH FOLLOW UP.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 25148689 ↗
• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. IT WAS NOTED THAT VEGETATION WAS ON THE RIGHT VENTRICULAR (RV) LEAD DISTAL TO THE TRICUSPID VALVE. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25047746 ↗
• MalfunctionApr 3, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS NOT IMPLANTED FOR AN UNKNOWN REASON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776846 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION, AND THE SOURCE OF INFECTION WAS STATED TO BE POSSIBLY FROM THE BLOOD IN ADDITION TO BACTEREMIA. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Sepsis; Unspecified Infection

  MAUDE report 24735292 ↗
• InjuryMar 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SOMETIMES SYMPTOMATIC WITH A FEELING OF THEIR HEART RACING WHEN THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FEATURE THAT MONITORS THE PACING AMPLITUDE THRESHOLD AND ADJUSTS THE OUTPUTS WAS RUNNING. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2026: IT WAS FURTHER REPORTED THAT THE BASE PACING RATE WAS INCREASED AND AUTOCAPTURE WAS PROGRAMMED OFF.

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

  MAUDE report 24690334 ↗
• InjuryMar 18, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE WAS POSSIBLY A VENTRICULAR TACHYCARDIA (VT) EPISODE NEEDING DETECTION AND THERAPY.  IT WAS NOTED THAT DETECTION AND THERAPY WERE WITHHELD DUE TO DISCRIMINATORS.  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 24627514 ↗
• InjuryMar 13, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). IT WAS NOTED THAT THE CRT-D DELIVERED ONE ROUND OF ATP WHICH DID NOT BREAK THE VENTRICULAR RATE AND THE RHYTHM THEN SELF-TERMINATED. IT WAS ALSO NOTED THAT THE PATIENT WAS HAVING ATRIAL TACHYCARDIA AT THE TIME OF THE EVENT. LASTLY, IT WAS NOTED THAT A NEW WAVELET TEMPLATE WAS COLLECTED. 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; Shock from Patient Lead(s)

  MAUDE report 24594600 ↗
• InjuryMar 3, 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). THE RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED OVERSENSING RESULTING IN T-WAVE OVERSENSING (TWOS) OVERSENSING. THE DEVICE AND LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED VIA FOLLOW-UP WITH THE CLINIC THAT THE PATIENT HAD BEEN HOSPITALIZED AND THEIR MEDICATIONS WERE ADJUSTED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24497246 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT EROSION WAS ALSO OBSERVED.

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

  MAUDE report 24470060 ↗
• MalfunctionFeb 18, 2026Signal Artifact/Noise; High impedance; Misconnection

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, UPON INSERTING THE LEAD PIN INTO THE DEVICE'S RIGHT VENTRICULAR (RV) PACE-SENSE PORT, NOISE AND UNDEFINED HIGH PACING IMPEDANCE WAS OBSERVED. WHEN THE LEAD WAS RETURNED TO THE ANALYZER FOR TESTING, IMPEDANCE WAS STABLE WITH A CLEAN SIGNAL. THE RIGHT ATRIAL (RA) LEAD WAS ALSO PLUGGED INTO THE DEVICE RV PACE-SESE PORT, AND AGAIN THERE WAS NOISE AND HIGH IMPEDANCE OBSERVED. THE PHYSICIAN REMOVED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE AND ELECTED TO IMPLANT A NEW DEVICE TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379840 ↗
• InjuryFeb 17, 2026Defibrillation/Stimulation Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY WERE IN THE HOSPITAL BECAUSE OF A FAINTING SPELL AND "PASSED OUT" THE DAY PRIOR. THE PATIENT STATED THAT "THEY SHOWED A TACHYCARDIA OR SOMETHING IN MY HEART THING". ADDITIONALLY, THE PATIENT MENTIONED THE PHYSICIAN THAT IMPLANTED THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SAID ONE OF THE LEADS WAS NOT PLACED RIGHT IN THEIR "FIRST ONE" AND WHEN THE PATIENT FAINTED, THE DEFIBRILLATION "DID NOT GO OFF". THE PATIENT ALSO STATED THE LEFT VENTRICULAR (LV) LEAD WAS NOT PLACED PROPERLY SO INSTEAD OF GOING IN TO RECONNECT THE LEAD, "IT WAS HARD FOR THEM TO SYNC BETWEEN THE RIGHT VENTRICULAR (RV) LEAD AND THE LV LEAD". IN ADDITION, THE PATIENT SAID THAT WHEN THEY WERE IN THE HOSPITAL, THE STAFF TOLD THEM THAT THE REASON THEY FAINTED WAS BECAUSE OF ATRIAL FIBRILLATION (AF) AND THAT THEIR DEVICE SHOULD HAVE GONE OFF. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Syncope/Fainting; Tachycardia

  MAUDE report 24368820 ↗