Crome™ HF Quad CRT-D MRI SureScan™ DTPC2QQRecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00763000178253), received between Nov 14, 2020 and Sep 4, 2026 — classified as 1 death, 54 injuries, 21 malfunctions.

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

Recalls naming this device

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. 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 · Recall details · FDA record ↗

4. 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 76 reports, 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 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 ↗
• InjuryOct 24, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH THRESHOLDS AND DRAINED THE BATTERY OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SUBSTANTIALLY. THE DEVICE AND LEAD WERE 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 23383662 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS REVISED DUE TO EROSION. THE DEVICE WAS INITIALLY IMPLANTED SUBCUTANEOUS AND WAS REVISED TO BE PLACED SUBMUSCULAR. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erosion; Pocket Erosion

  MAUDE report 22680530 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 4 MONTHS POST IMPLANT PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22301688 ↗
• MalfunctionJun 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT'S REPRESENTATIVE THAT THE PATIENT WAS TO REPORT TO THE EMERGENCY DEPARTMENT AFTER HEARING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) TONING TWO DAYS IN A ROW IN THE AFTERNOON. THE PATIENT'S REPRESENTATIVE NOTED THAT THE CLINICIANS AT THE HOSPITAL EXAMINED THE DATA AND THERE WAS NOTHING OBSERVED. THE CLINICIAN NOTED THAT "NOTHING TRIGGERED". THE PATIENT'S REPRESENTATIVE WAS CONCERNED AS TO WHY THE CRT-D WOULD EMIT A HIGH/LOW TONE BUT NOT MAKE ANY OBSERVATIONS AS TO WHY IT WAS ALERTING. THE REPRESENTATIVE WAS CONCERNED "SOMETHING MAY NOT BE WORKING PROPERLY". THE DEVICE 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 22286962 ↗
• MalfunctionMay 30, 2025Electromagnetic Interference; Device-Device Incompatibility; Electromagnetic Interference; Device-Device Incompatibility

  IT WAS REPORTED THAT MULTIPLE LEAD INTEGRITY ALERTS (LIA) TRIGGERED ON THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH RATE NON-SUSTAINED (HRNS) EPISODES AND SHORT VENTRICULAR INTERVALS. SHORT RUNS OF OVERSENSING WERE NOTED AND APPEARED CONSISTENT OVER THE COURSE OF THE LIAS. INTERFERENCE WAS REPORTEDLY NOTED WITH THE PATIENT'S CARDIAC CONTRACTILITY MODULATION (CCM) DEVICE WHICH WAS SUBSEQUENTLY DEACTIVATED; HOWEVER, THE HRNS EPISODES WERE NOTED TO HAVE OCCURRED PRIOR TO CCM IMPLANT AND POST-DEACTIVATION OF THE DEVICE. STABLE IMPEDANCE AND SENSING TRENDS AND THE ABSENCE OF A RISE IN THE FREQUENCY OF SHORT VENTRICULAR INTERVALS SUGGESTED AN ELECTROMAGNETIC INTERFERENCE (EMI) SOURCE OR MYOPOTENTIALS. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (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 22112972 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO ARRHYTHMIA NOTED AT THEIR FOLLOW-UP VISIT. THE PATIENT WAS DISCHARGED HOME AND THEN FELT THE DEVICE VIBRATING. THE PATIENT HAD ALSO BEEN EXPERIENCING TIREDNESS. THE PATIENT WAS ON HOSPICE FOR EXTRA CARE WHILE WAITING FOR A FUTURE LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Arrhythmia; Fatigue

  MAUDE report 21881552 ↗
• InjuryMar 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT MORE THAN A MONTH AFTER IMPLANT, THE PATIENT EXPERIENCED AN INFECTION WITH SWELLING, PURULENT DISCHARGE/PUS, PAIN AND DISCOMFORT. 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: Discomfort; Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 21652022 ↗
• InjuryMar 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE EXPLANTED AND THE RIGHT VENTRICULAR (RV) LEAD WAS CAPPED DUE TO A POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 21519001 ↗
• MalfunctionJan 23, 2025Pacing Problem; Device Sensing Problem; Pacing Problem; Device Sensing Problem

  IT WAS REPORTED THAT ATRIAL EVENTS APPEARED TO BE FALLING IN BLANKING AT TIMES POSSIBLY TRIGGERING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) DEVICE CLASSIFIED TERMINATION OF AT/AF DETECTED EVENT(S) AND OCCASIONAL INAPPROPRIATE ATRIAL PACING. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) 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 21225873 ↗
• InjuryJan 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT PROCEDURE, THE PATIENT DEVELOPED AN INFECTION. 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 21208424 ↗
• InjuryJan 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH LEFT VENTRICULAR (LV) LEAD THRESHOLDS. DURING THE LV LEAD EXTRACTION, THE SUPERIOR VENA CAVA (SVC) DISSECTED WHICH WAS NOTED TO BE CONTAINED. THE LV LEAD AND CRT-D WERE EXPLANTED AND REPLACED. AFTER CONNECTING THE LEADS TO THE NEW DEVICE AND PERFORMING AN AUTOMATED PACING POLARITIES TEST, THE PATIENT WENT INTO VENTRICULAR FIBRILLATION (VF) AND REQUIRED TO BE EXTERNALLY SHOCKED, WHICH WAS SUCCESSFUL. THE NEW CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Ventricular Fibrillation

  MAUDE report 21106404 ↗