Cobalt XT VR MRI SureScanRecalls & reported problems across all models

We found 2 models of Cobalt XT VR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 602 adverse event reports in the FDA's MAUDE database, received between Dec 11, 2020 and Sep 30, 2026 — classified as 8 deaths, 452 injuries, 142 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (207 reports).

4 FDA recall records name at least one of these models by its device 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. 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 VR 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, 2023Open, 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-1819-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 10, 2023Open, 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-1818-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jun 22, 2022Open, 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 ↗

4. Apr 12, 2022Open, 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 VR MRI SureScan problems

Cobalt XT VR MRI SureScan models

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

• Cobalt™ XT VR MRI SureScan™ DVPA2D4

  Implantable cardioverter defibrillator (non-CRT)
  3 recalls5 deaths534 reports
• Cobalt™ XT VR MRI SureScan™ DVPA2D1

  Implantable cardioverter defibrillator (non-CRT)
  3 recalls3 deaths68 reports

Recent Cobalt XT VR 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, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951526 ↗
• InjurySep 25, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50903486 ↗
• MalfunctionSep 25, 2026Electromagnetic Interference; Over-Sensing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902436 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection with fever, bacteremia, and purulent discharge/pus. The organism was identified as Staphylococcus aureus. No further patient complications have been reported as a result of this event.

  Patient problems: Bacteremia; Bacterial Infection; Fever; Purulent Discharge

  MAUDE report 50885192 ↗
• MalfunctionSep 23, 2026Defibrillation/Stimulation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872063 ↗
• MalfunctionSep 14, 2026Pacing Problem

  It was reported the patient was not feeling well due to slow heart rates below the programmed lower rate of the Implantable Cardioverter Defibrillator (ICD). The ICD remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Bradycardia

  MAUDE report 50747992 ↗
• InjurySep 12, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50744989 ↗
• MalfunctionSep 11, 2026Migration or Expulsion of Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50741125 ↗
• InjurySep 10, 2026Inappropriate/Inadequate Shock/Stimulation

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 50721357 ↗
• InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to a pocket infection and erosion. Wound dehiscence and purulent discharge were observed. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 50697342 ↗
• MalfunctionSep 9, 2026Pacing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) was inappropriately pacing around intrinsic beats. It was also reported that there was an increase in Sensing Integrity Counter (SIC). The device remains in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696891 ↗
• MalfunctionSep 4, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50619244 ↗
• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Bacteremia; Drug Resistant Bacterial Infection

  MAUDE report 50594476 ↗
• MalfunctionSep 2, 2026Migration or Expulsion of Device

  It was reported by the Implantable Cardioverter Defibrillator (ICD) patient that their device was making them feel tired, fatigue and was causing discomfort. The discomfort that the patient experience was that the device felt big, uncomfortable and that the device was moving around in the pocket especially at night and would hurt.  The device remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Fatigue; Pain

  MAUDE report 50568820 ↗
• MalfunctionSep 1, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549678 ↗

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