Cobalt™ DR MRI SureScan™ DDPB3D4Recalls & reported problems

Summary

The FDA's MAUDE database contains 648 adverse event reports that list this exact device (DI 00763000178390), received between Jul 1, 2020 and Sep 30, 2026 — classified as 14 deaths, 416 injuries, 218 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (172 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-1726-2023 · 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-1487-2022 · 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 648 reports, 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 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 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 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Implantable Cardioverter Defibrillator (ICD) and Right Atrial (RA) lead were explanted and the Right Ventricular (RV) lead was capped due to an infection and erosion. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 50130109 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a dual-chamber Implantable Cardioverter Defibrillator (ICD) patient experienced pocket erosion. The ICD system was explanted and replaced. No further patient complications have been reported as a result of this event.

  Patient problems: Erosion

  MAUDE report 50101661 ↗
• MalfunctionJul 30, 2026Pacing Problem

  It was further reported that the RV lead was reprogrammed. It was noted that the bradycardia was a result of the TWOS and had resolved.

  Patient problems: Bradycardia

  MAUDE report 50085328 ↗
• MalfunctionJul 1, 2026Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE SUPRA VENTRICULAR TACHYCARDIA (SVT).  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 25679453 ↗
• InjuryJun 26, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR AN EPISODE DETECTED AS VENTRICULAR TACHYCARDIA (VT) THAT WAS SUSPECTED TO BE A SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 25633145 ↗
• InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION WITH EROSION, PURULENT DISCHARGE/PUS, REDNESS, AND SWELLING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Erythema; Medical device site infection; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 25611872 ↗
• InjuryJun 22, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED AN INAPPROPRIATE SHOCK AND ANTI-TACHYCARDIA PACING (ATP) FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE AS VENTRICULAR TACHYCARDIA (VT). 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 25588759 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH SEPTIC SHOCK. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS SUBSEQUENTLY EXPLANTED DUE TO INFECTION WITH SEPTICEMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacterial Infection; Sepsis; Septic Shock

  MAUDE report 25512520 ↗
• MalfunctionJun 2, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT TELEMETRY COULD NOT BE ESTABLISHED WITH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). 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 25368659 ↗
• InjuryMay 22, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED BY THE PATIENT'S FAMILY MEMBER THAT THE PATIENT HAD "UGLY SHOCKS" AND IMPLIED THE SHOCKS WERE INAPPROPRIATE FOR MIS-DETECTED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. 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 25257131 ↗
• InjuryMay 22, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT POSSIBLY RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND HIGH VOLTAGE THERAPY FOR SUPRA VENTRICULAR TACHYCARDIA (SVT) AND ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS VENTRICULAR TACHYCARDIA (VT) AND 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 25256951 ↗
• InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING USE OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THERE WAS A CONCERN FOR POSSIBLE ICD POCKET INFECTION DUE TO REPORTED TENDERNESS AND DRAINAGE. THE PATIENT WAS TREATED WITH ANTIBIOTIC MEDICATION. HOWEVER, COMPUTED TOMOGRAPHY CHEST SCAN SHOWED NO FLUID COLLECTION, BLOOD CULTURES WERE NEGATIVE AND SERIAL EXAMINATIONS NOT CONSISTENT WITH ACTIVE INFECTION. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Fluid Discharge; Medical device site infection

  MAUDE report 25255318 ↗