Cobalt DR MRI SureScanRecalls & reported problems across all models

We found 2 models of Cobalt DR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 773 adverse event reports in the FDA's MAUDE database, received between Jul 1, 2020 and Sep 30, 2026 — classified as 16 deaths, 499 injuries, 258 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (204 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 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. 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-1726-2023 · 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-1725-2023 · 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-1487-2022 · 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 DR MRI SureScan problems

Cobalt DR MRI SureScan models

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

• Cobalt™ DR MRI SureScan™ DDPB3D4

  Implantable cardioverter defibrillator (non-CRT)
  3 recalls14 deaths648 reports
• Cobalt™ DR MRI SureScan™ DDPB3D1

  Pulse generator, permanent, implantable
  3 recalls2 deaths125 reports

Recent Cobalt 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.

• MalfunctionSep 30, 2026Signal Artifact/Noise; Electromagnetic Interference; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) experienced a partial electrical reset where diagnostic data such as pacing percentages and rate histograms were cleared, however parameter values remained unchanged. Additionally, an episode was noted to be Electromagnetic Interference/noise that was detected as Atrial Tachycardia/Atrial Fibrillation (AT/AF). It was further reported that the Right Atrial (RA) lead exhibited Far Field R-Wave (FFRW) oversensing. The ICD and RA lead remain in use. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949336 ↗
• MalfunctionSep 25, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904380 ↗
• InjurySep 25, 2026Signal Artifact/Noise; Misconnection; Over-Sensing; Pacing Problem

  It was reported that the Right Ventricular (RV) lead triggered Lead Integrity Alert (LIA) for Sensing Integrity Counter (SIC) and High Rate Non-Sustained episodes and had exhibited noise and oversensing resulting in inhibition of pacing. It was also stated that the Implantable Cardioverter Defibrillator (ICD) exhibited connection issue. A chest Xray indicated that the device and RV lead exhibited connection issue as the RV lead was not inserted past the setscrew. The Lead was reposition in device connector port and the Device and lead 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 50902720 ↗
• InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50891882 ↗
• InjurySep 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received Anti-Tachycardia Pacing (ATP) and high voltage therapy from the Implantable Cardioverter Defibrillator (ICD) on multiple episodes of possible Supra Ventricular Tachycardia (SVT) that the device classified as Ventricular Fibrillation (VF). The ICD remains in use. It was also reported that the Right Atrial (RA) lead exhibited  undersensing during atrial events resulting in unnecessary pacing at times. The lead 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 50819489 ↗
• InjurySep 14, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50762744 ↗
• MalfunctionSep 10, 2026Inappropriate or Unexpected Reset; Reset Problem

  It was further reported that the patient had an in-office interrogation done and the device was programmed back to pre-reset parameters. The device remains in use.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50718108 ↗
• MalfunctionSep 4, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50616697 ↗
• MalfunctionSep 1, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: Dizziness

  MAUDE report 50545259 ↗
• MalfunctionAug 25, 2026Pacing Problem; Device Sensing Problem

  It was reported that the patient presented to the emergency department with chest discomfort and vomiting. It was noted that stored episodes noted atrial events falling in the blanking period during Atrial Tachycardia/Atrial Fibrillation (AT/AF) events resulting in unnecessary pacing at times. The Implantable Cardioverter Defibrillator (ICD) remains in use. No further patient complications have been reported as a result of this event.

  Patient problems: Discomfort; Vomiting

  MAUDE report 50436968 ↗
• InjuryAug 23, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) may have delivered inappropriate defibrillation therapy for Atrial Fibrillation (AF) with Rapid Ventricular Response detected as Ventricular Fibrillation (VF). It was also noted that the patient experienced syncope. The 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 50397597 ↗
• InjuryAug 17, 2026Mechanical Problem

  It was reported that two days post implant, the Right Atrial (RA) lead dislodged. During the revision procedure, the RA lead was explanted and replaced. However, when attempting to connect the new RA lead back to the existing Implantable Cardioverter Defibrillator (ICD), the setscrew would not reengage. The ICD was also 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 50286700 ↗
• InjuryAug 17, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  It was reported that the patient received possible inappropriate therapy for Atrial Fibrillation (AF) with Rapid Ventricular Response (RVR) that the device detected as Ventricular Fibrillation (VF). 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 50279742 ↗
• MalfunctionAug 11, 2026Signal Artifact/Noise; Electromagnetic Interference; Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212404 ↗
• InjuryAug 6, 2026Intermittent Capture; High impedance; Mechanical Problem; Pacing Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) had exhibited connection issues as the setscrew was loose and caused pacing problems and no capture. An X-Ray indicated that the Right Atrial (RA) lead pin was not properly set in the header. The device interrogation indicated that there was intermitted capture and Out of Range (OOR) high atrial pacing impedance. The lead was removed from the header and tested with no noise noted. The ICD was explanted and replace, the Lead was reposition and re-implanted into the new device and 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 50166008 ↗

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