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

We found 2 models of Cobalt XT HF CRT-D MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 701 adverse event reports in the FDA's MAUDE database, received between Mar 3, 2021 and Sep 29, 2026 — classified as 20 deaths, 469 injuries, 212 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (100 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 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 XT HF 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. Apr 16, 2024Class IIOpen, Classified

   Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

   Z-2192-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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 ↗

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-1777-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. 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 ↗

5. 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 · names 2 of these models · Recall details · FDA record ↗

6. 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 ↗

Most reported Cobalt XT HF CRT-D MRI SureScan problems

Cobalt XT HF CRT-D MRI SureScan models

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

• Cobalt™ XT HF CRT-D MRI SureScan™ DTPA2D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls12 deaths452 reports
• Cobalt™ XT HF CRT-D MRI SureScan™ DTPA2D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls8 deaths249 reports

Recent Cobalt XT HF 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.

• MalfunctionSep 29, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50935474 ↗
• MalfunctionSep 28, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50918505 ↗
• InjurySep 25, 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. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50901154 ↗
• InjurySep 24, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50886465 ↗
• 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 ↗
• DeathSep 22, 2026Failure to Deliver Shock/Stimulation

  It was reported by the patient's family that the patient expired. The patient's family stated the Cardiac Resynchronization Therapy Defibrillator (CRT-D) did not shock the patient and wanted to know why. It was further reported that the CRT-D was not checked after the patient expired.

  Patient problems: Insufficient Information

  MAUDE report 50861684 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Hematoma; Pain

  MAUDE report 50811506 ↗
• MalfunctionSep 16, 2026Signal Artifact/Noise; Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794129 ↗
• InjurySep 15, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device provided inappropriate therapy for detected Ventricular Tachycardia (VT) episodes that were suspected Supra Ventricular Tachycardia (SVT). 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 50776652 ↗
• InjurySep 14, 2026Migration or Expulsion of Device

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) had not been sutured during the implant procedure, and it had migrated downward in the pocket which pulled the slack out of the leads. It was further reported that the Right Ventricular (RV) lead had partially dislodged. The CRT-D and the RV lead were explanted and replaced. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756048 ↗
• MalfunctionSep 10, 2026Pacing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50723744 ↗
• InjurySep 9, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50697571 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50697523 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient experienced bacteremia leading to septicemia post generator change. The patient was hospitalized and treated with antibiotics. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system remains in use. The patient is a part icipant in a clinical study. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia

  MAUDE report 50671196 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50620069 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls