Cobalt™ XT HF Quad CRT-D MRI SureScan™ DTPA2QQRecalls & reported problems
Medtronic, Inc. · CRTD DTPA2QQ COBALT XT HF QUAD MRI DF4 · Class 3 · Implant
All models of Cobalt XT HF Quad CRT-D MRI SureScan (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
4 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This is the Medtronic Cobalt XT HF Quad CRT-D, an implanted defibrillator with heart resynchronization pacing. The 1,618 reports often describe the device misreading heart signals, pacing problems, and inappropriate or inadequate shocks, and many mention infections. The records include 38 deaths, 1,098 injuries and 482 malfunctions. There are 4 open recalls, covering reduced shock energy, a telemetry error and a manufacturing weld crack.
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
- 1,639
- Deaths reported
- 40
- Injuries reported
- 1,112
- Recalls naming it
- 4
Summary
The FDA's MAUDE database contains 1,639 adverse event reports that list this exact device (DI 00763000178093), received between Mar 1, 2021 and Sep 30, 2026 — classified as 40 deaths, 1,112 injuries, 487 malfunctions.
The most frequently reported specific device problem is “Device Sensing Problem” (266 reports).
4 FDA recall records name this device's 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, 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
- Apr 16, 2024Class IIOpen, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Z-2194-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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-1779-2023 · 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-1486-2022 · 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
- Adverse Event Without Identified Device or Use Problem660
- Device Sensing Problem266
- Pacing Problem232
- Inappropriate/Inadequate Shock/Stimulation182
- Appropriate Device Problem Term/Code Not Available133
- Mechanical Problem104
- Premature Discharge of Battery86
- Electromagnetic Interference68
Patient problems
- No Clinical Signs, Symptoms or Conditions561
- Unspecified Infection446
- Shock from Patient Lead(s)184
- Erythema113
- Purulent Discharge89
- Discomfort75
- Erosion70
- Pain68
Recent adverse event reports
The 25 most recent of 1,639 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952738 ↗InjurySep 30, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
Patient problems: Shock from Patient Lead(s)
MAUDE report 50951371 ↗MalfunctionSep 29, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941286 ↗MalfunctionSep 29, 2026Migration or Expulsion of Device
Patient problems: Palpitations
MAUDE report 50938823 ↗MalfunctionSep 28, 2026Electromagnetic Interference
Patient problems: Shock from Patient Lead(s)
MAUDE report 50923904 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50923676 ↗InjurySep 28, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem
Patient problems: Tachycardia
MAUDE report 50922786 ↗InjurySep 28, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
Patient problems: Shock from Patient Lead(s)
MAUDE report 50922491 ↗MalfunctionSep 25, 2026High impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903728 ↗InjurySep 24, 2026Premature Discharge of Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889025 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that three months post Cardiac Resynchronization Therapy Defibrillator (CRT-D) implant, the patient experienced a device pocket infection, discomfort, pain, purulent discharge, redness, and swelling. The CRT-D system was explanted and then replaced six days later. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Swelling/ Edema
MAUDE report 50888990 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
It was reported that approximately one month post replacement procedure, the patient developed a pocket infection. It was noted that the patient developed purulent discharge/pus. The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted and replaced with a Leadless Implantable Pulse Generator (IPG). No further patient complications have been reported as a result of this event.
Patient problems: Purulent Discharge; Unspecified Infection
MAUDE report 50877036 ↗InjurySep 23, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) may have provided inappropriate Anti-Tachycardia Pacing (ATP) and high voltage therapy for an Supra Ventricular Tachycardia (SVT) episode detected as Ventricular Fibrillation (VF). The CRT-D 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 50871323 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to infection and septic shock. A leadless Implantable Pulse Generator (IPG) was implanted. No further patient complications have been reported as a result of this event.
Patient problems: Septic Shock; Unspecified Infection
MAUDE report 50870640 ↗InjurySep 23, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacteremia; Bacterial Infection; Erosion; Hematoma; Muscle Weakness/Atrophy
MAUDE report 50870057 ↗MalfunctionSep 18, 2026Mechanical Problem; Low impedance; Unstable Impedance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829288 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50828186 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Unspecified Infection
MAUDE report 50810932 ↗InjurySep 17, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809256 ↗MalfunctionSep 16, 2026Appropriate Device Problem Term/Code Not Available
Patient problems: Confusion/ Disorientation; Low Blood Pressure/ Hypotension
MAUDE report 50794119 ↗MalfunctionSep 16, 2026Failure to Deliver Shock/Stimulation; Device Sensing Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) inappropriately withheld detection and therapy due to Supra Ventricular Tachycardia (SVT) that was identified as sustained Ventricular Tachycardia (VT). The CRT-D remains in use. No patient complications have been reported as a result of this event.
Patient problems: Tachycardia
MAUDE report 50793021 ↗InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) device system was explanted due to a pocket infection with purulent discharge. No further patient complications have been reported as a result of this event.
Patient problems: Medical device site infection; Purulent Discharge
MAUDE report 50787145 ↗InjurySep 15, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Bacterial Infection
MAUDE report 50780920 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Erythema; Purulent Discharge; Unspecified Infection
MAUDE report 50762489 ↗InjurySep 14, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted due to pocket infection with erosion, redness and discomfort. No further patient complications have been reported as a result of this event.
Patient problems: Discomfort; Erosion; Erythema; Medical device site infection
MAUDE report 50757530 ↗
Other Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) devices
- Gallant™ CDHFA500QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)2 recalls58 deaths8,401 reports
- Quartet™ 1458Q-86St. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)207 deaths6,631 reports
- QUADRA ASSURA MP™ CD3369-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)103 deaths6,084 reports
- VIGILANT™ X4 CRT-D G247Boston Scientific Corporation · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)17 deaths2,066 reports
- Quadra Assura™ CD3365-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)53 deaths2,056 reports
- Unify Assura™ CD3357-40QSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)54 deaths1,784 reports
- Unify Assura™ CD3357-40CSt. Jude Medical, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)56 deaths1,588 reports
- Claria MRI™ Quad CRT-D SureScan™ DTMA1QQMedtronic, Inc. · Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)22 deaths1,479 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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