Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2QQRecalls & reported problems

Summary

The FDA's MAUDE database contains 868 adverse event reports that list this exact device (DI 00763000178178), received between Aug 20, 2020 and Sep 30, 2026 — classified as 19 deaths, 537 injuries, 312 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (145 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. 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-1784-2023 · 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. Nov 5, 2020Class IIOpen, Classified

   Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

   Z-1480-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 868 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 50953550 ↗
• MalfunctionSep 30, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951224 ↗
• MalfunctionSep 28, 2026Pacing Problem; Under-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925250 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  It was reported by the patient that experienced symptoms of chest tightness and discomfort since adjustments were made to the Cardiac Resynchronization Therapy Defibrillator (CRT-D) settings. The patient also noted a significant decrease in battery life and expressed feeling unwell, particularly when active. The CRT-D remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Chest Pain; Discomfort

  MAUDE report 50920742 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacterial Infection; Fungal Infection; Medical device site infection

  MAUDE report 50904054 ↗
• InjurySep 24, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Right Atrial (RA) lead exhibited undersensing of Atrial Fibrillation (AF) noted on a stored episode. The clinician stated that the patient received Anti-Tachycardia Pacing (ATP) and high-voltage therapy for Atrial Fibrillation (AF) with Rapid Ventricular Response that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) classified as Ventricular Tachycardia (VT). The clinician further stated that the patient was experiencing the inappropriate shocks due to AF and undersensing issues. The lead and device 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 50889104 ↗
• InjurySep 24, 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 mobile echogenic mass/vegetation attached to the Right Atrial (RA) lead. It was noted that the patient also experienced discomfort. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Medical device site infection

  MAUDE report 50881989 ↗
• InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia

  MAUDE report 50868542 ↗
• InjurySep 17, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) inappropriately withheld therapy for Ventricular Tachycardia (VT) detected as Supra Ventricular Tachycardia (SVT). Reprogramming was done to turn off a discriminator and the CRT-D remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Tachycardia

  MAUDE report 50807368 ↗
• InjurySep 10, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Right Atrial (RA) lead exhibited undersensing during Atrial Tachycardia/Atrial Fibrillation (AT/AF) stored episodes resulting in termination of AT/AF detected event(s) in progress. It was further reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) treated an episode for Atrial Fibrillation (AF) with Rapid Ventricular Response versus Ventricular T achycardia/Ventricular Fibrillation (VT/VF). The RA lead and CRT-D 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 50718441 ↗
• InjurySep 9, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698311 ↗
• InjurySep 9, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Right Ventricular (RV) lead exhibited intermittent T-Wave Oversensing (TWOS). Additionally, the patient received inappropriate therapy for Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR) that was detected as Ventricular Fibrillation (VF). The Cardiac Resynchronization Therapy Defibrillator (CRT-D) and RV lead remain in use. No further patient complications have been reported as a result of this event.

  Patient problems: Ventricular Fibrillation

  MAUDE report 50693326 ↗
• InjurySep 3, 2026Pacing Problem

  It was reported that the patient experienced syncope and bradycardic episodes where their heart rate was below the lower programmed rate of the Cardiac Resynchronization Therapy Defibrillator (CRT-D) on external telemetry, and no pacing spikes were noted. It was noted that the episodes were around the time that the patient was having Premature Ventricular Contractions (PVC), bigeminy, and trigeminy. The CRT-D remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia; Syncope/Fainting

  MAUDE report 50590538 ↗
• MalfunctionSep 2, 2026Signal Artifact/Noise; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50571670 ↗
• InjuryAug 31, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device system was explanted and replaced die to an unspecified reason. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50533156 ↗
• InjuryAug 27, 2026Electromagnetic Interference; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received a shock when attempting to start a grill. Upon further review; a Lead Integrity Alert (LIA) was triggered due to Sensing Integrity Counter (SIC) and High-Rate Non-Sustained episodes. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) exhibited Oversensing of Electromagnetic Interference resulting in non-physiologic intervals resulting in arrhythmia misclassification and inappropriate therapies delivered. 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 50483108 ↗
• InjuryAug 27, 2026Device Sensing Problem

  It was reported by a patient representative that the patient's Cardiac Resynchronization Therapy Defibrillator (CRT-D) device "started failing" and delivered 16 shocks in a row. The patient was in the Intensive Care Unit (ICU) for 2 weeks. 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 50482784 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a leadless pacemaker due to infection with bacteremia. The source of the infection was reported as Fungemia & Endocarditis. Additionally, the patient may have been septic. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Endocarditis; Fungal Infection; Sepsis

  MAUDE report 50460828 ↗
• InjuryAug 21, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a Leadless implantable pulse generator (IPG). No additional details were provided. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50382662 ↗
• MalfunctionAug 7, 2026Signal Artifact/Noise; Electromagnetic Interference

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50175076 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Right Atrial (RA) lead exhibited high capture thresholds. When the RA lead was being extracted, purulent fluid and pus was observed. It was decided that the entire Cardiac Resynchronization Therapy Defibrillator (CRT-D) system would be explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50136730 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) patient was in the hospital for a back fracture and blood infection. It was noted that the device was toning for Out of Range (OOR) low Right Ventricular (RV) lead pacing impedance and high RV lead thresholds were also observed. It was noted that the lead trends appeared stable however the recent decrease in pacing impedance was suspected to be related to the blood infection and medical issues going on. Several days later the CRT-D system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50037280 ↗
• MalfunctionJul 10, 2026Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) RESULTING IN MISCLASSIFICATION OF EPISODES AND UNNECESSARY PACING AT TIMES. THE RA LEAD ALSO EXHIBITED HIGH CAPTURE THRESHOLDS. ADDITIONALLY, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED EPISODES OF SUPRA VENTRICULAR TACHYCARDIA (SVT) AS VENTRICULAR TACHYCARDIA (VT). THE RA LEAD AND CRT-D 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 25787661 ↗
• MalfunctionJul 8, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS THAT INDUCED AN ATRIAL ARRHYTHMIA. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Atrial Fibrillation; Shock from Patient Lead(s); Tachycardia

  MAUDE report 25752778 ↗
• InjuryJun 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 INFECTION. IT WAS NOTED THAT THE PATIENT EXPERIENCED EROSION AND WOUND DEHISCENCE. ANTIBIOTICS WERE PROVIDED TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 25661980 ↗