Crome HF Quad CRT-D MRI SureScanRecalls & reported problems across all models

We found 2 models of Crome HF Quad CRT-D MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 85 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2020 and Sep 4, 2026 — classified as 1 death, 58 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (12 reports).

5 FDA recall records name at least one of these models by its device identifier, 5 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

Crome HF Quad CRT-D 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. Apr 16, 2024Class IIOpen, Classified

   Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

   Z-2195-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. 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-1788-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. 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-1787-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

4. 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-1490-2022 · Root cause: Device Design · names 2 of these models · Recall details · FDA record ↗

5. 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-1268-2022 · Root cause: Software design · names 2 of these models · Recall details · FDA record ↗

Most reported Crome HF Quad CRT-D MRI SureScan problems

Crome HF Quad CRT-D MRI SureScan models

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

• Crome™ HF Quad CRT-D MRI SureScan™ DTPC2QQ

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  4 recalls1 death76 reports
• Crome™ HF Quad CRT-D MRI SureScan™ DTPC2Q1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls9 reports

Recent Crome HF Quad CRT-D MRI SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Abscess; Fever; Unspecified Infection

  MAUDE report 50618528 ↗
• InjuryAug 21, 2026Premature Discharge of Battery

  It was reported that there was high Left Ventricular (LV) lead threshold and premature battery depletion on the Cardiac Resynchronization Therapy Defibrillator (CRT-D). No intervention was taken with the LV lead and it remains in use. The device was 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 50375228 ↗
• InjuryAug 17, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that approximately one month post generator changeout, the patient experienced a pocket infection with Methicillin-resistant Staphylococcus aureus (MRSA). The Cardiac Resynchronization Therapy Defibrillator (CRT-D) system was explanted. No further patient complications have been reported as a result of this event.

  Patient problems: Bacterial Infection; Endocarditis; Unspecified Infection

  MAUDE report 50286762 ↗
• InjuryMay 29, 2026Premature Discharge of Battery

  IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT ALTHOUGH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS BRAND NEW, IT ONLY HAD A CERTAIN AMOUNT OF BATTERY LIFE REMAINING. THE PATIENT'S SURGEON WAS ALSO REPORTEDLY CONCERNED ABOUT THE ESTIMATED REMAINING LONGEVITY. PLACEMENT OF ONE OF THE PATIENT'S LEADS WAS REPORTEDLY CAUSING THE SITUATION. PROGRAMMING CHANGES WERE ATTEMPTED BUT SETTINGS WERE ULTIMATELY LEFT AS THEY WERE. THE CRT-D AND 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 25329073 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO THE PATIENT DEVELOPING ENDOCARDITIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS A PARTICIPANT IN A CLINICAL STUDY.

  Patient problems: Endocarditis

  MAUDE report 25230642 ↗
• InjuryMay 15, 2026Misconnection

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD, IT WAS NOTED THAT THERE WAS A DEVICE CONNECTOR PORT PROBLEM AND THAT THE RV LEAD PIN ENCOUNTERED AN INSERTION ISSUE THAT THE LEAD HAD UNSEATED FROM THE CONNECTOR PORT AND PULLED BACK. THE POCKET WAS RE-OPENED, AND IT WAS FOUND THE RV LEAD WAS NOT FULLY SEATED IN THE HEADER. THE RV LEAD WAS REMOVED AND REINSERTED AND FIXED INTO THE HEADER. THE CRT-D AND RV 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 25189540 ↗
• MalfunctionApr 8, 2026Signal Artifact/Noise

  IT WAS REPORTED THAT DURING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT ATTEMPT, SENSING ONLY NOISE ON THE HEADER IN THE RIGHT VENTRICULAR PORT OCCURRED. THE CRT-D WAS NOT IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820544 ↗
• InjuryMar 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST POCKET REVISION PROCEDURE AND ANTIBACTERIAL ABSORBABLE ENVELOPE IMPLANT, THE PATIENT EXPERIENCED POCKET EROSION WITH METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS INFECTIVE ENDOCARDITIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, THE SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Drug Resistant Bacterial Infection; Endocarditis; Pocket Erosion

  MAUDE report 24706432 ↗
• InjuryMar 17, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED FOUR DAYS LATER. THE REASON FOR EXPLANT WAS NOT PROVIDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24622184 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE MONTHS POST-CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM IMPLANT WITH AN ANTIBACTERIAL ABSORBABLE ENVELOPE, THE PATIENT DEVELOPED A POCKET INFECTION. THE PATIENT EXPERIENCED DISCOMFORT, PAIN, REDNESS AND SWELLING. THE CRT-D SYSTEM WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Swelling/ Edema

  MAUDE report 24548997 ↗
• InjuryMar 3, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS FURTHER REPORTED THAT THE THERAPIES WERE CONFIRMED TO BE INAPPROPRIATE. THE PATIENT WAS IN ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VF. INTERVENTION WAS PERFORMED ON THE CRT-D.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 24498854 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS INFECTION. ADDITIONALLY, THE PATIENT EXPERIENCED BACTEREMIA AND VEGETATION OF THE TRICUSPID VALVE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Medical device site infection

  MAUDE report 24315034 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM EXHIBITED INFECTION. THE SYSTEM WAS EXPLANTED WITHOUT REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24069793 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO YEARS AFTER IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM, THE PATIENT EXPERIENCED AN INFECTION. THE DEVICE AND LEADS WERE WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23586155 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. THE RIGHT VENTRICULAR (RV) LEAD AND LEFT VENTRICULAR (LV) LEAD EXHIBITED HIGH THRESHOLDS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23586011 ↗

Other Medtronic, Inc. products

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