Crome VR MRI SureScanRecalls & reported problems across all models

We found 2 models of Crome VR MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Nov 19, 2020 and Sep 24, 2026 — classified as 24 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Device Sensing 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 VR 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, 2023Open, 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-1823-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 10, 2023Open, 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-1822-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

3. Jun 22, 2022Open, 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-1489-2022 · Root cause: Device Design · Recall details · FDA record ↗

4. Apr 12, 2022Open, 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 VR MRI SureScan problems

Crome VR MRI SureScan models

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

• Crome™ VR MRI SureScan™ DVPC3D4

  Pulse generator, permanent, implantable
  3 recalls18 reports
• Crome™ VR MRI SureScan™ DVPC3D1

  Pulse generator, permanent, implantable
  2 recalls12 reports

Recent Crome VR 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 24, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888558 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE ICD AND RV LEAD WERE EXPLANTED DUE TO INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 24887751 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED DUE TO INFECTION WITH VEGETATION NOTED AT THE LOCATION OF THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT EXPERIENCED WOUND DEHISCENCE, DISCOMFORT, PAIN, REDNESS AND PURULENT DISCHARGE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Discomfort; Erythema; Medical device site infection; Pain; Purulent Discharge; Wound Dehiscence

  MAUDE report 23711031 ↗
• InjuryNov 20, 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 WITH PAIN, REDNESS, AND SWELLING. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 23609814 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS REMOVED DUE TO POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23589859 ↗
• InjurySep 15, 2025Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO HIGH-RATE NON-SUSTAINED EPISODES AND SENSING INTEGRITY COUNTER (SIC). IT WAS ALSO NOTED THAT THE RV LEAD EXHIBITED INTERMITTENT UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGMS). THE RV LEAD REMAINS IN USE. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH HYPERTENSION WITH FOURTEEN INAPPROPRIATE SHOCKS IN SETTING OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WITH ANOTHER EPISODE OF APPROPRIATE SHOCK IN SETTING OF POLYMORPHIC VENTRICULAR TACHYCARDIA (VT) AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AT END OF SERVICE (EOS). THE ICD WAS EXPLANTED AND REPLACED AND THE PATIENT RECEIVED A ATRIO-VENTRICULAR NODAL ABLATION PROCEDURE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: High Blood Pressure/ Hypertension; Shock from Patient Lead(s)

  MAUDE report 23057704 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PUS AND DRAINAGE. A POCKET INFECTION WAS SUSPECTED. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET WAS REVISED AND CLEANED. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Fluid Discharge; Purulent Discharge; Unspecified Infection

  MAUDE report 22537949 ↗
• InjuryMay 1, 2025Defibrillation/Stimulation Problem; Device Sensing Problem; Defibrillation/Stimulation Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY WITHHELD THERAPY INAPPROPRIATELY FOR EPISODES OF VENTRICULAR TACHYCARDIA (VT) BY THE ONSET DISCRIMINATOR. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE ICD WAS REPROGRAMMED.

  Patient problems: Tachycardia

  MAUDE report 21942577 ↗
• InjuryJan 31, 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 AND THERE WAS VEGETATION ON THE RIGHT VENTRICULAR (RV) LEAD. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS SUBSEQUENTLY EXPLANTED AND REPLACED WITH A TEMPORARY LEADLESS PACEMAKER. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 21282552 ↗
• InjuryNov 7, 2024Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS. THE HEALTH CARE PROFESSIONAL (HCP) STATED THE DEVICE SHOCKED THE PATIENT AS THEY WERE BEING BROUGHT TO THE HOSPITAL. THERE WAS NO ARRYTHMIA NOTED SINCE THE LAST INTERROGATION. NO ADDITIONAL INFORMATION COULD BE OBTAINED THROUGH FOLLOW-UP. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Dizziness; Shock from Patient Lead(s)

  MAUDE report 20629839 ↗
• InjuryMay 23, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT APPROXIMATELY ONE WEEK POST-GENERATOR CHANGE, DURING THE WOUND CHECK, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH/UNDEFINED RV COIL AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES. IN ADDITION, THE TIP TO COIL IMPEDANCE WAS OBSERVED TO BE HIGH AS WELL. IT WAS FURTHER REPORTED THAT THE PATIENT WAS BROUGHT INTO THE CATH LAB AND REATTACHMENT OF THE LEAD CONNECTORS TO THE HEADER WAS PERFORMED AND THE PROBLEM WAS SOLVED. THE LEAD TESTED NORMALLY THROUGH THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND A DEFIBRILLATION THRESHOLDS (DFT) WAS PERFORMED NORMALLY. THE DEVICE AND RV LEAD 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 19387973 ↗
• InjurySep 5, 2023Defibrillation/Stimulation Problem; Defibrillation/Stimulation Problem

  IT WAS FURTHER REPORTED THAT THE PATIENT WAS EVENTUALLY INTUBATED FOR VF STORM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683673 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); WAS EXPLANTED DUE TO POCKET INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 17605546 ↗
• InjuryAug 18, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH SYNCOPE. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); DELIVERED INAPPROPRIATE THERAPY FOR AN EPISODE OF VENTRICULAR TACHYCARDIA (VT) BUT THE RHYTHM WAS DETECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE(RVR). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s); Syncope/Fainting

  MAUDE report 17571178 ↗
• InjuryJul 11, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD); DELIVERED A SHOCK FOR AN EPISODE OF FAST VENTRICULAR TACHYCARDIA (FVT) BUT THE RHYTHM WAS SUSPECTED TO BE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE(RVR). THE ICD 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 17298621 ↗

Other Medtronic, Inc. products

• CapSureFix Novus MRI SureScan29 models · 87,337 reports
• Medtronic Sprint Quattro Lead67 models · 45,880 reports · 1 recall
• Intellis AdaptiveStim3 models · 35,469 reports
• SYNCHROMED II11 models · 32,260 reports · 4 recalls
• CAPSUREFIX NOVUS17 models · 27,547 reports
• INTERSTIM30 models · 24,415 reports · 1 recall
• Sprint Quattro Secure S MRI SureScan7 models · 23,549 reports
• Medtronic LINQ Heart Monitor11 models · 19,366 reports · 3 recalls