Crome™ HF Quad CRT-D MRI SureScan™ DTPC2Q1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000178260), received between Dec 8, 2020 and Aug 21, 2026 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Missing Test Results” (3 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.

Recalls naming this device

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

2. 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 ↗

3. 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionOct 21, 2025Electromagnetic Interference; Over-Sensing; Electromagnetic Interference; Over-Sensing

  IT WAS REPORTED THAT THERE WAS OVERSENSING ON THE ATRIAL CHANNEL OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THAT APPEARED TO BE DUE TO ELECTROMAGNETIC INTERFERENCE. 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 23348915 ↗
• MalfunctionJun 30, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT "ABOUT THREE WEEKS AGO I STARTED TO NOTICE THAT MY DEVICE WAS STANDING UP ON EDGE AFTER SLEEPING ON MY LEFT SIDE, NOW IT SEEMS LIKE IT SITS SIDEWAYS, SORT OF OUT OF PLACE AND LOOKS BRUISED. IT HURTS FROM TIME TO TIME, NOT ALL THE TIME." THE PATIENT NOTIFIED THE FACILITY AND WAS ASKED TO SEND A REMOTE TRANSMISSION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bruise/Contusion; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 22358020 ↗
• InjuryJun 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR ¿HEART GOT INFECTED¿ AND THEY HAD TO TAKE OUT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE RIGHT ATRIAL (RA) LEAD, LEFT VENTRICULAR (LV) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE CAPPED. THE CRT-D SYSTEM WAS REPLACED WITH A LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22207149 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A POCKET INFECTION DUE TO A NON-HEALING POCKET INCISION. THE PATIENT FURTHER EXPERIENCED PAIN, REDNESS, SWELLING, AND WOUND DEHISCENCE. 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: Erythema; Pain; Swelling/ Edema; Unspecified Infection; Wound Dehiscence

  MAUDE report 21943885 ↗
• MalfunctionNov 28, 2022Unable to Obtain Readings; Missing Test Results; Unable to Obtain Readings; Missing Test Results

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) INTERROGATION REPORT DISPLAYED QUESTION MARKS FOR THE REMAINING LONGEVITY ESTIMATION AND A GREY BAR WAS PRESENT INDICATING THE BATTERY VOLTAGE MEASUREMENT WAS NOT TAKEN. THE 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 15868676 ↗
• InjuryAug 1, 2022Unable to Obtain Readings; Missing Test Results; Unable to Obtain Readings; Missing Test Results

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS STUCK IN A NON-WIRELESS TELEMETRY SESSION. THE DEVICE WAS INTERROGATED, AND THE PERSISTENT SESSION ACTIVE FLAG WAS CLEARED USING A NON-BLUETOOTH TELEMETRY SESSION. 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 15142084 ↗
• MalfunctionMay 17, 2021Inappropriate or Unexpected Reset; Inappropriate or Unexpected Reset

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) EXPERIENCED A PARTIAL POWER ON RESET (POR). THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11832014 ↗
• MalfunctionDec 8, 2020Electrical /Electronic Property Problem; Unable to Obtain Readings; Missing Test Results; Electrical /Electronic Property Problem; Unable to Obtain Readings; Missing Test Results

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) LONGEVITY ESTIMATE DISPLAYED GREY BAR WITH QUESTION MARKS ¿???¿. 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 10972399 ↗