Cobalt™ XT DR MRI SureScan™ DDPA2D4Recalls & reported problems
Medtronic, Inc. · ICD DDPA2D4 COBALT XT DR MRI DF4 USA · Class 3 · Implant
All models of Cobalt XT DR MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Medtronic Cobalt XT DR MRI SureScan is an implantable defibrillator that also paces the heart. Its 1,568 reports describe many cases of the device misreading heart rhythms and giving inappropriate shocks or pacing, and some mention infections. The reports mention 30 deaths and 1,185 injuries. There are 3 recalls, all open, about possible weakened shock energy and a communication error.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 1,603
- Deaths reported
- 30
- Injuries reported
- 1,211
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 1,603 adverse event reports that list this exact device (DI 00763000178345), received between Jan 21, 2021 and Sep 30, 2026 — classified as 30 deaths, 1,211 injuries, 362 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (585 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.
Reports received per month
Recalls naming this device
- 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 ↗
- 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 ↗
- 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
Device problems
- Device Sensing Problem585
- Adverse Event Without Identified Device or Use Problem564
- Inappropriate/Inadequate Shock/Stimulation405
- Pacing Problem354
- Failure to Deliver Shock/Stimulation103
- Mechanical Problem72
- Appropriate Device Problem Term/Code Not Available68
- Over-Sensing51
Patient problems
- No Clinical Signs, Symptoms or Conditions412
- Shock from Patient Lead(s)402
- Unspecified Infection326
- Tachycardia110
- Erythema75
- Discomfort72
- Bacteremia67
- Medical device site infection65
Recent adverse event reports
The 25 most recent of 1,603 reports, 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, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 50916318 ↗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 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Medical device site infection; Purulent Discharge
MAUDE report 50891003 ↗MalfunctionSep 24, 2026Pacing Problem; Device Sensing Problem
It was reported that the Right Ventricular (RV) lead exhibited ventricular undersensing resulting in inappropriate pacing. The RV lead remains in use. It was also reported that the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) for a Ventricular Fibrillation (VF) episode that was detected as Supra Ventricular Tachycardia (SVT). The Implantable Cardioverter Defibrillator (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 50884036 ↗InjurySep 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
Patient problems: Shock from Patient Lead(s)
MAUDE report 50870893 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pocket Erosion
MAUDE report 50828546 ↗InjurySep 18, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that one day post implant, the patient received possible inappropriate Anti-Tachycardia Pacing (ATP) and a shock for episodes of Supra Ventricular Tachycardia (SVT) detected as Ventricular Tachycardia (VT). Ventricular rates were at 188 beats per minute. 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); Tachycardia
MAUDE report 50823419 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Discomfort; Erosion; Erythema; Medical device site infection; Pain; Swelling/ Edema
MAUDE report 50821888 ↗InjurySep 18, 2026Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) device provided inappropriate therapy for detected Ventricular Fibrillation (VF) that was suspected Atrial Tachycardia/Atrial Fibrillation (AT/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 50819676 ↗InjurySep 18, 2026Mechanical Problem; Misconnection
It was reported that after inserting the Right Ventricular (RV) lead the electrical measurements were stable; however, after a few minutes noise was observed which inhibited pacing. When the lead was reconnected to the can, the same issue occurred. All electrical measurements of the RV lead were stable when testing through the analyzer. The Implantable Cardioverter Defibrillator (ICD) was attempted/not used and a new ICD was implanted without issue. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819382 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Purulent Discharge; Swelling/ Edema; Unspecified Infection; Wound Dehiscence
MAUDE report 50810106 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Implantable Cardioverter Defibrillator (ICD) patient experienced a pocket infection with redness and bacter emia. The device system was explanted. No further patient complications have been reported as a result of this event.
Patient problems: Bacteremia; Erythema; Medical device site infection
MAUDE report 50804931 ↗InjurySep 17, 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) for what appeared to be atrial tachycardia with 1:1 conduction that was detected as Ventricular Fibrillation (VF). The patient also received ATP only on multiple prior episodes that appeared to be atrial tachycardia with 1:1 conduction that were detected as Ventricular Tachycardia (VT). The ICD remains in use. It was also reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS). 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 50800545 ↗MalfunctionSep 16, 2026Electrical /Electronic Property Problem; Reset Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50796433 ↗
Other Implantable cardioverter defibrillator (non-CRT) devices
- EMBLEM™ MRI S-ICD A219Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)2 recalls36 deaths15,404 reports
- EMBLEM™ S-ICD A209Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)1 recall7 deaths6,788 reports
- EMBLEM™ S-ICD 3501Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)7 deaths4,936 reports
- ENDOTAK RELIANCE® G 0185Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,632 reports
- VIGILANT™ EL ICD DR D233Boston Scientific Corporation · Implantable cardioverter defibrillator (non-CRT)9 deaths1,563 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall35 deaths1,426 reports
- Durata™ 7122St. Jude Medical, Inc. · Implantable cardioverter defibrillator (non-CRT)27 deaths1,377 reports
- Evera MRI™ XT DR SureScan® DDMB1D4Medtronic, Inc. · Implantable cardioverter defibrillator (non-CRT)1 recall24 deaths1,241 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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