Cobalt™ XT VR MRI SureScan™ DVPA2D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 534 adverse event reports that list this exact device (DI 00763000178468), received between Dec 11, 2020 and Sep 25, 2026 — classified as 5 deaths, 408 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (190 reports).

3 FDA recall records name this device's identifier, 3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

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-1819-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 534 reports, in the reporter's own words as published by the FDA.

• 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 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 1, 2026Communication or Transmission Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549678 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an infection. It was noted that the infection growth was seen on the Right Ventricular (RV) lead and there was also vegetation on the RV lead. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50483124 ↗
• InjuryAug 24, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that three weeks after implant, the patient experienced bleeding from their device pocket. A pocket revision was done with cautery, and the Implantable Cardioverter Defibrillator (ICD) remains in use. No patient complications have been reported as a result of this event.

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

  MAUDE report 50419946 ↗
• InjuryAug 21, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that there was oversensing, undersensing, and a Lead Integrity Alert (LIA) due to High Rate Non-Sustained episodes and short ventricular intervals on the Right Ventricular (RV) lead. It was also noted the Implantable Cardioverter Defibrillator (ICD) detected Supra Ventricular Tachycardia (SVT) as Ventricular Fibrillation (VF) and the patient received inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy. The lead remains in use. The device was reprogrammed and remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50380129 ↗
• InjuryAug 19, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50325659 ↗
• InjuryAug 16, 2026Appropriate Device Problem Term/Code Not Available

  It was reported that more than three weeks post implant, the Implantable Cardioverter Defibrillator (ICD) system was explanted due to an unknown reason. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50264873 ↗
• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that one month post implant, the Implantable Cardioverter Defibrillator (ICD) system was explanted due to a pocket i nfection. No further patient complications have been reported as a result of this event.

  Patient problems: Medical device site infection

  MAUDE report 50256144 ↗
• InjuryAug 11, 2026Device-Device Incompatibility

  It was reported that during a Magnetic Resonance Imaging (MRI) procedure the Implantable Cardioverter Defibrillator (ICD) started to vibrate even when it was in MRI mode. All therapies were turned it off completely, but the patient still felt a vibration as the scan was continued.  The MRI scan was unable to be completed.  The ICD 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 50211404 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted and replaced due to an endocarditis infection. No further patient complications have been reported as a result of this event.

  Patient problems: Endocarditis; Unspecified Infection

  MAUDE report 50201975 ↗
• InjuryAug 7, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) was visible from the incision area two months post-generator replacement procedure and the device pocket was infected with pus around the area. The ICD was removed and the Right Ventricular (RV) lead was capped. A new system was implanted on the patient's opposite side several days later. No further patient complications have been reported as a result of this event.

  Patient problems: Purulent Discharge; Unspecified Infection; Wound Dehiscence

  MAUDE report 50175918 ↗
• MalfunctionAug 5, 2026Pacing Problem; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150410 ↗
• InjuryJul 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient was possibly inappropriately shocked for Atrial Fibrillation (AF) with Rapid Ventricular Response detected as Ventricular Tachycardia (VT). The Implantable Cardioverter Defibrillator (ICD) 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 50090968 ↗
• InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) system was explanted due to infection. Additionally, there was vegetation observed on the lead. No further patient complications have been reported as a result of this event.

  Patient problems: Unspecified Infection

  MAUDE report 50090953 ↗
• InjuryJul 29, 2026Failure to Deliver Shock/Stimulation

  It was reported that the patient commented that "I was in the hospital but did not shock. My heart stopped and nothing happened with the Implantable Cardioverter Defibrillator (ICD). Is it even working?  I have not seen a doctor since (b)(6) 2025, only the app is monitoring. On (b)(6) 2027 they said everything was ok with the transmission, when I just got out of the hospital for two months. I do not know if it is working. I do not get it. The heart clinic sent me an appointment for September but they did not  know I was in the hospital for two months. Tomorrow I am going to see a new Cardiologist."  The ICD remains in use.  No further patient complications have been reported as a result of this event.

  Patient problems: Cardiac Arrest

  MAUDE report 50077572 ↗