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

We found 2 models of Cobalt XT HF Quad CRT-D MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,833 adverse event reports in the FDA's MAUDE database, received between Mar 1, 2021 and Sep 30, 2026 — classified as 47 deaths, 1,236 injuries, 550 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (300 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 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. Apr 16, 2024Class IIOpen, Classified

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

   Z-2194-2024 · 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-2193-2024 · 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-1779-2023 · 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-1778-2023 · 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 Quad CRT-D MRI SureScan problems

Cobalt XT 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™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls40 deaths1,639 reports
• Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls7 deaths194 reports

Recent Cobalt XT 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.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952738 ↗
• InjurySep 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50951371 ↗
• MalfunctionSep 29, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50941286 ↗
• MalfunctionSep 29, 2026Migration or Expulsion of Device

  Patient problems: Palpitations

  MAUDE report 50938823 ↗
• 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 28, 2026Electromagnetic Interference

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50923904 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50923676 ↗
• InjurySep 28, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  Patient problems: Tachycardia

  MAUDE report 50922786 ↗
• InjurySep 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50922491 ↗
• MalfunctionSep 25, 2026High impedance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903728 ↗
• InjurySep 24, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889025 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that three months post Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a device pocket infection, discomfort, pain, purulent discharge, redness, and swelling. The CRT-D system was explanted and then replaced six days later. No further patient complications have been reported as a result of this event.

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

  MAUDE report 50888990 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately one month post replacement procedure, the patient developed a pocket infection. It was noted that the patient developed purulent discharge/pus. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a Leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 50877036 ↗
• InjurySep 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) may have provided inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy for an Supra Ventricular Tachycardia (SVT) episode detected as Ventricular Fibrillation (VF). 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 50871323 ↗
• InjurySep 23, 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 and septic shock. A leadless Implantable Pulse Generator (IPG) was implanted. No further patient complications have been reported as a result of this event.

  Patient problems: Septic Shock; Unspecified Infection

  MAUDE report 50870640 ↗

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