Primo MRI VR SureScanRecalls & reported problems across all models

We found 2 models of Primo MRI VR SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Mar 9, 2020 and Dec 22, 2025 — classified as 17 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Inappropriate/Inadequate Shock/Stimulation” (7 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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

Primo MRI VR 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-1815-2023 · 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-1814-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Primo MRI VR SureScan problems

Primo MRI VR SureScan models

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

• Primo MRI™ VR SureScan™ DVMD3D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall17 reports
• Primo MRI™ VR SureScan™ DVMD3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall5 reports

Recent Primo MRI VR SureScan adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryDec 22, 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 DUE TO INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 23871446 ↗
• MalfunctionJul 11, 2025Over-Sensing; Impedance Problem; Over-Sensing; Impedance Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED A LEAD INTEGRITY ALERT (LIA) FOR ELEVATED SENSING INTEGRITY COUNTER (SIC) AND PACING IMPEDANCE SPIKES SUSPECTED TO BE IN RELATION TO INTERACTION WITH THE PATIENT¿S CARDIAC CONTRACTILITY MODULATION (CCM) DEVICE. THE ICD 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 22482033 ↗
• InjuryMar 31, 2025Over-Sensing; Inappropriate/Inadequate Shock/Stimulation; Over-Sensing; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE WHICH RESULTED IN AN INAPPROPRIATE SHOCK AND ACCUMULATION OF SHORT V-VS AND NON-SUSTAINED VENTRICULAR TACHYCARDIA EVENTS. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (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 21731032 ↗
• InjuryJan 28, 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 DUE TO SEPSIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 21260367 ↗
• MalfunctionJan 6, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE CLINICIAN ATTEMPTED TO SEND A TRANSMISSION FROM THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), HOWEVER RECEIPT OF A TRANSMISSION COULD NOT BE CONFIRMED.  IT WAS FURTHER REPORTED THAT THE REASON FOR THE ATTEMPTED TRANSMISSION WAS THAT THE PATIENT REPORTED TO THEIR CLINICIAN THAT THEIR ICD "STOPPED WORKING". THE ICD 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 21081501 ↗
• InjuryMar 15, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AFTER RECEIVING SHOCKS FROM THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). AN INTERROGATION SHOWED PACING THERAPY AND DEFIBRILLATION SHOCKS WERE DELIVERED FOR EPISODES DETECTED IN THE VENTRICULAR FIBRILLATION (VF) ZONE. IT WAS SUSPECTED THAT THE RHYTHM MAY HAVE BEEN RAPID VENTRICULAR RESPONSE WITH SUPRA VENTRICULAR TACHYCARDIA (SVT) IN PROGRESS AT THE TIME OF THERAPY, AND THERAPIES MAY HAVE BEEN INAPPROPRIATE. 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 18915311 ↗
• InjuryDec 14, 2023Inappropriate/Inadequate Shock/Stimulation; Inappropriate/Inadequate Shock/Stimulation

  IT WAS REPORTED BY THE HOSPICE HEALTHCARE PROFESSIONAL THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS "MALFUNCTIONING SINCE IT SHOCKED THE PATIENT TWICE". 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 18324419 ↗
• InjuryOct 5, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED SHOCKS FOR A DETECTED VENTRICULAR TACHYCARDIA (VT) EPISODE THAT WAS SUSPECTED SUPRA VENTRICULAR TACHYCARDIA (SVT). THE DEVICE 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 17878381 ↗
• MalfunctionSep 26, 2023Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT UPON INTERROGATION PRIOR TO IMPLANT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DISPLAYED A GREY BAR FOR BATTERY LONGEVITY. THE ICD WAS NOT USED AND A NEW ICD WAS IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816418 ↗
• InjurySep 18, 2023Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED A SHOCK FOR AN EPISODE OF ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE IM PLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS LATER EXPLANTED AND REPLACED DUE TO AN UPGRADE TO A BI-VENTRICULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (BI-V ICD). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17769728 ↗
• InjuryFeb 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POCKET EROSION. THE DEVICE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pocket Erosion

  MAUDE report 16449270 ↗
• InjuryJan 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THAT ONE MONTH AFTER THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED, THE PATIENT DEVELOPED A POCKET INFECTION FROM THE GENERATOR CHANGE OUT. THE ICD SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 16108302 ↗
• MalfunctionOct 27, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT AT IMPLANT ATTEMPT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR'S (ICD'S) SET SCREW WOULD NOT ENGAGE AND HOLD IN PLACE ON A PIN PLUG FOR A COMPETITOR'S RIGHT VENTRICULAR (RV) LEAD. THE ICD WAS EVENTUALLY NOT USED IN THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680674 ↗
• InjuryOct 10, 2022Adverse 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 AND REPLACED DUE TO AN INFECTION. A NEW ICD SYSTEM WAS IMPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Unspecified Infection

  MAUDE report 15572487 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 14197877 ↗

Other Medtronic, Inc. products

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