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

We found 2 models of Crome HF CRT-D MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2021 and Jun 9, 2026 — classified as 1 death, 28 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (8 reports).

4 FDA recall records name at least one of these models by its device 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. 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 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. 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-1786-2023 · Root cause: Under Investigation by firm · 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-1785-2023 · 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 · names 2 of these models · 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 · names 2 of these models · Recall details · FDA record ↗

Most reported Crome HF CRT-D MRI SureScan problems

Crome HF 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 CRT-D MRI SureScan™ DTPC2D4

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls1 death28 reports
• Crome™ HF CRT-D MRI SureScan™ DTPC2D1

  Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
  3 recalls13 reports

Recent Crome HF 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.

• InjuryJun 9, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION. 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: Unspecified Infection

  MAUDE report 25448860 ↗
• 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 POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Medical device site infection

  MAUDE report 24314306 ↗
• MalfunctionJan 20, 2026Failure to Interrogate

  IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO SEND A REMOTE TRANSMISSION, AND TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE PATIENT WAS REFERRED TO THEIR CLINIC FOR A DEVICE CHECK. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO PA TIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120420 ↗
• MalfunctionJan 13, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED A TONE AND NOTED IT COULD BE A ¿BATTERY LIFE CONCERN OR A LEAD MIGHT HAVE BEEN MISALIGNED.¿ THE CRT-D AND LEFT VENTRICULAR (LV) 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 24056953 ↗
• InjuryNov 20, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED POSSIBLE INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) CLASSIFIED VENTRICULAR TACHYCARDIA (VT) ALLOWED DUE TO WAVELET. 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 23609920 ↗
• InjuryNov 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) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. IT WAS NOTED THAT THE SOURCE OF THE INFECTION WAS BLOOD BORNE. DISCOMFORT, EROSION, PAIN, REDNESS, AND VEGETATION OF THE TRICUSPID VALVE WERE ALSO NOTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erosion; Erythema; Pain; Unspecified Infection

  MAUDE report 23465695 ↗
• InjuryOct 15, 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) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE ORGANISM WAS IDENTIFIED AS ENTEROCOCCUS FAECALIS. THE PATIENT EXPERIENCED FEVER, SEPSIS, AND BACTEREMIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Bacterial Infection; Fever; Sepsis

  MAUDE report 23303760 ↗
• InjuryAug 5, 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) SYSTEM WAS EXPLANTED APPROXIMATELY THREE WEEKS POST IMPLANT DUE TO A POCKET INFECTION WITH NOTED REDNESS AND SWELLING. UPON DEVICE INTERROGATION, IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND WAS NOT CAPTURING. THE PATIENT RECEIVED ANTIBIOTICS. A TEMPORARY PACEMAKER WAS PLACED, AND ONE WEEK LATER THE SYSTEM WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22717121 ↗
• MalfunctionJul 21, 2025Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE WHEN THE LEFT BUNDLE BRANCH PACING (LBBP) LEAD WAS CONNECTED TO THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THERE WAS A NOTED CHANGE IN MORPHOLOGY SEEN ON THE SURFACE AND 12 LEAD ELECTROGRAMS (EGM) COMPARED TO THE ANALYZER. THE LEAD WAS DISCONNECTED AND TESTED WITH THE ANALYZER WITH NOTING THE NORMAL MORPHOLOGY INITIALLY DESIRED. TROUBLESHOOTING STEPS WERE PERFORMED AND THE ISSUE WAS RESOLVED. WHEN ATTEMPTING TO RECONNECT THE LEAD TO THE CRT-D HEADER IT WAS NOTED THAT THE SETSCREW BECAME STRIPPED. THE CRT-D WAS REPLACED WITH A NEW DEVICE AND THE PROCEDURE COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22560767 ↗
• InjuryJul 2, 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) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. THE PATIENT EXPERIENCED DISCOMFORT, REDNESS, AND SWELLING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Swelling/ Edema; Unspecified Infection

  MAUDE report 22384592 ↗
• InjuryJun 24, 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) SYSTEM WAS REMOVED APPROXIMATELY TWO WEEKS POST-GENERATOR REPLACEMENT PROCEDURE DUE TO REDNESS AND SUSPECTED POCKET INFECTION. A NEW SYSTEM WAS IMPLANTED THE FOLLOWING WEEK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection

  MAUDE report 22322437 ↗
• InjuryMay 23, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXHIBITED PREMATURE BATTERY DEPLETION. 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 22080854 ↗
• InjuryApr 24, 2025Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Impedance Problem; Signal Artifact/Noise; Mechanical Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FRACTURE. IT WAS NOTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGER DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND HIGH SENSING INTEGRITY COUNTER (SIC). RECORDED EPISODES SHOW CLEAR EVIDENCE OF NOISE ON TIP TO RING ELECTROGRAMS (EGM). THE HEALTHCARE PROFESSIONAL WAS UNABLE TO REPRODUCE THE NOISE, BUT DID SEE A NON-PHYSIOLOGIC VARIATION IN IMPEDANCES WHEN DOING SERIAL IMPEDANCE MEASUREMENTS. IT WAS NOTED THAT GIVEN THE RECENT GENERATOR CHANGE, THE ISSUE WAS LIKELY DUE TO A LEAD/HEADER CONNECTION ISSUE. DETECTIONS WERE TURNED OFF AND THE LEAD WAS LATER CAPPED AND REPLACED. 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 21903746 ↗
• InjuryMar 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A HEMATOMA AND IT WAS EVACUATED. DURING THE EVACUATION PROCEDURE, THE PHYSICIAN DISCONNECTED THE LEADS FROM THE HEAD TO CLEAN THE LEADS. THE LEFT VENTRICULAR (LV) LEAD PORT SET SCREW BECAME DISCONNECTED FROM THE HEADER AND COULD NOT BE ENGAGED. THE SET SCREW CAME OUT OF THE HEADER WITH A SCREWDRIVER. A NEW DEVICE WAS SUCCESSFULLY IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 21682593 ↗
• MalfunctionDec 27, 2024Pacing Problem; Inappropriate or Unexpected Reset; Pacing Problem; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD A DIAGNOSTIC ELECTRICAL RESET. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT'S WATCH CONSISTENTLY READS THEIR HEARTRATE IN THE FORTY BEATS PER MINUTE RANGE WHICH IS BELOW THE CRT-D PROGRAMMED LOWER RATE. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 21027118 ↗

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