Cobalt XT DR MRI SureScanRecalls & reported problems across all models

We found 2 models of Cobalt XT DR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 1,844 adverse event reports in the FDA's MAUDE database, received between Jan 21, 2021 and Sep 30, 2026 — classified as 33 deaths, 1,375 injuries, 436 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (657 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 DR 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-2209-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Dec 7, 2023Class IIOpen, Classified

   During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting after a failure. Some batteries were therefore retested and passed.

   Z-0779-2024 · 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-1723-2023 · 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-1721-2023 · 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-1485-2022 · 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 DR MRI SureScan problems

Cobalt XT DR MRI SureScan models

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

• Cobalt™ XT DR MRI SureScan™ DDPA2D4

  Implantable cardioverter defibrillator (non-CRT)
  3 recalls30 deaths1,603 reports
• Cobalt™ XT DR MRI SureScan™ DDPA2D1

  Implantable cardioverter defibrillator (non-CRT)
  5 recalls3 deaths241 reports

Recent Cobalt XT DR 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: Unspecified Infection; Wound Dehiscence

  MAUDE report 50955149 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50954540 ↗
• MalfunctionSep 30, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953666 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Unspecified Infection

  MAUDE report 50951206 ↗
• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Medical device site infection

  MAUDE report 50949719 ↗
• InjurySep 29, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50938848 ↗
• MalfunctionSep 29, 2026Migration or Expulsion of Device

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

  MAUDE report 50935984 ↗
• MalfunctionSep 28, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50924330 ↗
• InjurySep 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50916632 ↗
• InjurySep 28, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem

  Patient problems: Tachycardia

  MAUDE report 50916331 ↗
• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 50916318 ↗
• InjurySep 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Erythema; Medical device site infection; Swelling/ Edema

  MAUDE report 50903449 ↗
• MalfunctionSep 25, 2026Misconnection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899817 ↗
• InjurySep 25, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy for Supra Ventricular Tachycardia (SVT) that the Implantable Cardioverter Defibrillator (ICD) detected as Ventricular Fibrillation (VF). 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 50897106 ↗
• InjurySep 24, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: Ventricular Fibrillation

  MAUDE report 50892459 ↗

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