Cobalt HF Quad CRT-D MRI SureScanRecalls & reported problems across all models

We found 2 models of Cobalt HF Quad CRT-D MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 995 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2020 and Sep 30, 2026 — classified as 28 deaths, 613 injuries, 354 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (158 reports).

5 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Cobalt HF Quad CRT-D MRI SureScan recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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. 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-1783-2023 · 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-1488-2022 · Root cause: Device Design · names 2 of these models · 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 · names 2 of these models · Recall details · FDA record ↗

5. 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 Cobalt HF Quad CRT-D MRI SureScan problems

Cobalt HF Quad CRT-D MRI SureScan models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls19 deaths868 reports
• Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls9 deaths127 reports

Recent Cobalt HF Quad CRT-D MRI SureScan adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionSep 2, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568325 ↗

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