Cobalt™ HF Quad CRT-D MRI SureScan™ DTPB2Q1Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 00763000178185), received between Oct 21, 2020 and Sep 2, 2026 — classified as 9 deaths, 76 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Pacing Problem” (15 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-1783-2023 · 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-1488-2022 · 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-1267-2022 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Premature Discharge of Battery

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568325 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the Cardiac Resynchronization Therapy Defibrillator (CRT-D) was explanted and replaced. The reason for explant was not reported. No patient complications have been reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50060715 ↗
• InjuryJun 1, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY ELEVEN WEEKS AFTER IMPLANT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 25350287 ↗
• MalfunctionMay 12, 2026High impedance; Mechanical Problem

  IT WAS FURTHER REPORTED THAT AT AN IN OFFICE CHECK ALL NUMBERS WERE IN RANGE, NO ACTION WAS TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149090 ↗
• InjuryApr 16, 2026Premature Discharge of Battery

  IT WAS REPORTED THAT THE DEVICE REACHED 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 24902012 ↗
• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO BACTEREMIA, SEPTIC SHOCK, AND CARDIOGENIC SHOCK. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bacteremia; Cardiogenic Shock; Septic Shock

  MAUDE report 24437093 ↗
• MalfunctionFeb 17, 2026High impedance; Mechanical Problem; Damaged Thread

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE PHYSICIAN TRIED TO ENGAGE THE RIGHT VENTRICULAR (RV) LEAD INTO THE IS1 PORT. AFTER SEVERAL REMOVAL AND REENGAGEMENTS THE SET SCREW SEEMED TO HAVE DISLODGED FROM THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE HEADER AND HAD COMPLETELY COME OUT OF THE DEVICE HEADER. ADDITIONALLY, IT WAS NOTED THAT THE CRT-D SETSCREW COULD NOT TURN, LOOSE SETSCREW, THE SETSCREW DISENGAGED FROM THREADS , DAMAGED/STRIPPED AND A SETSCREW/WRENCH INTERFACE PROBLEM OCCURRED. IT WAS ALSO REPORTED THAT THE RV LEAD, DEFIBRILLATOR COIL IMPEDANCE WAS CONSTANTLY HIGH BUT UPON INITIAL LEAD CONNECTION THE DEFIBRILLATOR COIL IMPEDANCE WAS WITHIN NORMAL RANGE. THE CRT-D WAS REPLACED. THE RV LEAD WAS CONNECTED TO A NEW DEVICE AND 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 24369658 ↗
• MalfunctionJan 26, 2026Misconnection; Low impedance

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE HEALTHCARE PROFESSIONAL (HCP) NOTED AN ALERT FOR COMPETITOR RIGHT VENTRICULAR (RV) LEAD LOW IMPEDANCE. THE HCP SUSPECTED COMPETITOR RV LEAD AND CRT-D CONNECTION ISSUE. 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 24178854 ↗
• InjuryJan 16, 2026Failure to Capture; High impedance; Misconnection; Low impedance; Impedance Problem; High Capture Threshold

  IT WAS REPORTED THAT DURING USE OF THE LEFT VENTRICULAR (LV) LEAD THE PATIENT EXPERIENCED PHRENIC NERVE STIMULATION AND THE LEAD WAS RE-PROGRAMMED. IT WAS ALSO REPORTED THAT LATER AN ALERT TRIGGERED FOR LV LEAD LOW IMPEDANCE AT WHICH TIME LV THRESHOLD WENT TO HIGH MEASUREMENT. THE LV LEAD IMPEDANCE WAS ALSO VARYING, ALL LV VECTORS WERE LOW AND HAD BEEN OCCURRING SINCE THREE WEEKS POST IMPLANT. ADDITIONALLY, IT WAS NOTED THAT THE LV LEAD IS EXPERIENCING AN INSULATION ISSUE THAT IS IMPACTING ONE OR MORE OF THE LV ELECTRODE CONDUCTORS. IT WAS LATER REPORTED THAT THE LEAD WAS EXHIBITING HIGH UNDEFINED IMPEDANCE. MULTIPLE PRIOR CHANGES TO PROGRAMMING WERE NOTED. THE LEAD WAS ALSO NOT CAPTURING IN ANY CONFIGURATION. IMAGING DID NOT REVEAL ANY ADDITIONAL INFORMATION AS THE LEAD APPEARED TO BE SEATED IN THE HEADER OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). THE PHYSICIAN, HOWEVER, WAS CONCERNED ABOUT A CONNECTION ISSUE WITH THE CRT-D. THE LEAD AND CRT-D REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24096870 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ONE MONTH POST IMPLANT, THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED DUE TO A SUSPECTED POCKET INFECTION. A REPLACEMENT CRTD SYSTEM WAS LATER IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 24037578 ↗
• MalfunctionJan 2, 2026Pacing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) THE PATIENT WAS SYMPTOMATIC WITH TRACKING AT THE UPPER TRACK RATE AND DUE TO THE DEVICE MODE SWITCH CANNOT BE PROGRAMMED TO A RATE SLOWER THAN 133 BEATS PER MINUTE (BPM).  THE CRT-D REMAINS IN USE.  NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 23943311 ↗
• InjuryDec 5, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT DURING USE OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE DEVICE PR LOGIC FEATURE THAT DISCRIMINATES BETWEEN LIFE-THREATENING VENTRICULAR TACHYCARDIAS (VT/VF) AND LESS SEVERE SUPRAVENTRICULAR TACHYCARDIAS (SVT), INAPPROPRIATELY DISCRIMINATED VT. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728735 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT VEGETATION WAS FOUND ON THE RIGHT VENTRICULAR (RV) LEAD AND A BACTEREMIA INFECTION WAS NOTED. 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: Bacteremia; Medical device site infection

  MAUDE report 23707569 ↗
• DeathNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SEPSIS/SEPTICEMIA INFECTION. THE ORGANISM RESPONSIBLE FOR THE INFECTION WAS IDENTIFIED AS PSEUDOMONAS AERUGINOSA. THE LEADS WERE EXPLANTED AND CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) REMAINS IN THE PATIENT. APPROXIMATELY TWO MONTHS AFTER EXPLANT THE PATIENT WAS REPORTED AS DECEASED. THE PATIENT WAS ON HOME HOSPICE CARE AND THE CAUSE OF DEATH WAS REPORTED AS HEART FAILURE.

  Patient problems: Bacterial Infection; Sepsis; Unspecified Infection

  MAUDE report 23502055 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED STAPHYLOCOCCUS AUREUS BACTEREMIA WITH PURULENT DISCHARGE. 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: Bacteremia; Bacterial Infection; Purulent Discharge

  MAUDE report 23316757 ↗
• InjuryOct 16, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED BY A PATIENT REPRESENTATIVE THAT "EARLIER THIS SUMMER WE KEPT HEARING BEEPING. IT WAS THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). WE WENT TO THE CLINIC AND THEY CHECKED THE DEVICE AND SAID THERE WAS ONE YEAR LEFT OF THE BATTERY. THEY ALSO DID A CHEST XRAY AND EVERYTHING WAS GOOD. SHORTLY AFTER THAT THE DEVICE WAS BURNING THE PATIENT'S CHEST, THAT HAS GONE AWAY; NOW TODAY WE HAVE A LONG BEEP." IT WAS CONFIRMED THAT THE TONE THEY WERE HEARING WAS A STEADY TONE AND THE PATIENT/PATIENT REPRESENTATIVE WAS EDUCATED ON MAGNET TONE. IT WAS ALSO REPORTED THAT THE PATIENT DID HAVE A MAGNET NEAR THE CHEST. THE PATIENT WAS REFERRED TO THE HEART CLINIC/PHYSICIAN. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23314323 ↗
• MalfunctionAug 11, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT CALLED STATING WHEN THEY WERE IN A HOT TUB, THEY RECEIVED A CALL FROM THE MEDICAL TEAM, "WARNING THAT THE DEVICE WAS GOING TO GO OFF." FOLLOW UP RECEIVED FROM THE CLINIC INDICATED THAT THERE WAS ELECTROMAGNETIC INTERFERENCE ON THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DUE TO THE HOT TUB. 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 22773732 ↗
• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Endocarditis

  MAUDE report 22707146 ↗
• MalfunctionJul 15, 2025Electromagnetic Interference; Electromagnetic Interference

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE THAT WAS REPRODUCED IN CLINIC WHEN THE PATIENT¿S ARMS EXTENDED WIDELY OUT IN DIFFERENT DIRECTIONS. ADDITIONALLY, THE LEAD DISPLAYED INCREASED SENSING INTEGRITY COUNTER (SIC) OVER TIME, T-WAVE OVERSENSING (TWOS) POST BI-VENTRICULAR PACING, AND OVERSENSING IN THE BI-POLAR (SENSING ELECTROGRAMS). THE PATIENT EXPERIENCED DIZZINESS AND PRESYNCOPE. THE RV LEAD WAS REPROGRAMMED AND LATER EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SHOWED EVIDENCE OF ELECTROMAGNETIC INTERFERENCE ON STORED ELECTROGRAMS (EGM). THE CRT-D WAS EXPLANTED AND ELECTIVELY REPLACED AT THE TIME OF THE LEAD REVISION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509359 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN UNSPECIFIED INFECTION. THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 22485353 ↗
• DeathJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEPSIS AND POSSIBLE ASPIRATION. THE PATIENT WAS REPORTED TO BE DECEASED. THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) FOR HIGH-RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). THE RIGHT VENTRICULAR (RV) LEAD ALSO EXHIBITED LOSS OF CAPTURE DURING A ANTI-TACHYCARDIA PACING (ATP) TREATED EPISODE. IT WAS UNABLE TO BE DETERMINED IF THE LIA WAS A PERFORMANCE ISSUE OR DUE TO AN AGONAL RHYTHM. ADDITIONAL INFORMATION RELATED TO THE CAUSE AND CIRCUMSTANCES OF DEATH WERE REQUESTED AND NOT RECEIVED.

  Patient problems: Aspiration/Inhalation; Sepsis

  MAUDE report 22395797 ↗
• InjuryJun 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE WEEKS AFTER THE IMPLANT OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), THE PATIENT DEVELOPED A HEMATOMA. THE POCKET WAS REVISED TO DRAIN THE HEMATOMA AND THE POCKET WAS CLOSED BACK UP. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hematoma

  MAUDE report 22289211 ↗
• InjuryMay 27, 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 INAPPROPRIATE HIGH VOLTAGE THERAPY AND INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED AS VENTRICULAR TACHYCARDIA (VT). ADDITIONALLY, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH IMPEDANCE. THE CRT-D AND RA LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 22090452 ↗
• InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21995537 ↗
• InjuryMar 3, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THE PATIENT FEELS FAIRLY SYMPTOMATIC (SHORT OF BREATH) WHEN IN ATRIAL FIBRILLATION (AF). IT WAS NOTED THAT THE PATIENT HAS HAD MULTIPLE AF ABLATIONS THAT HAVE NOT RESOLVED THE PATIENT¿S AF. IT WAS ALSO NOTED THAT WHEN THE PATIENT IS IN AF, OCCASIONAL ATRIAL PACES ARE COMING IN DUE TO PROGRAMMED DEVICE TIMING. 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: Atrial Fibrillation; Dyspnea

  MAUDE report 21505173 ↗