Primo MRI DR SureScanRecalls & reported problems across all models

We found 2 models of Primo MRI DR SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 74 adverse event reports in the FDA's MAUDE database, received between Jul 30, 2019 and Sep 28, 2026 — classified as 54 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (22 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 DR 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-1718-2023 · 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-1717-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Primo MRI DR SureScan problems

Primo MRI DR SureScan models

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

• Primo MRI™ DR SureScan™ DDMD3D4

  Implantable cardioverter defibrillator (non-CRT)
  1 recall52 reports
• Primo MRI™ DR SureScan™ DDMD3D1

  Implantable cardioverter defibrillator (non-CRT)
  1 recall22 reports

Recent Primo MRI DR SureScan adverse event reports

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

• MalfunctionSep 28, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50921920 ↗
• MalfunctionSep 8, 2026Device Sensing Problem

  It was reported that the Right Ventricular (RV) lead exhibited T-Wave Oversensing (TWOS) resulting in misclassification of Ventricular Fibrillation (VF), High Rate Non-Sustained, and Non-Sustained Ventricular Tachycardia episodes. The Right Atrial (RA) lead also exhibited oversensing resulting in misclassification of Atrial Tachycardia/Atrial Fibrillation (AT/AF) episodes. It was also reported that the Implantable Cardioverter Defibrillator (ICD) may have inappropriately classified AT/AF with fast ventricular response as monitored Ventricular Tachycardia (VT) at times. The RV lead, RA lead and ICD 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 50674200 ↗
• MalfunctionMay 21, 2026Pacing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA WHEN THEIR HEART RATE FELL BELOW THE LOWER PACING LIMIT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 25249781 ↗
• InjuryMar 10, 2026Insufficient Device Problem Information

  FOLLOW UP WITH THE CLINIC INDICATED THAT THERE WERE NO ISSUES WITH THE DEVICE OR LEADS AND NO SHOCKS OR ANTI-TACHYCARDIA PACING (ATP). IT WAS NOTED THAT THE VENTRICULAR TACHYCARDIA (VT) MONITOR ZONE HAD BEEN ENABLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562541 ↗
• InjuryMar 10, 2026Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND INAPPROPRIATE HIGH VOLTAGE THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DETECTED AS FAST VENTRICULAR TACHYCARDIA (FVT). IT WAS NOTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON INTRAVENOUS (IV) MEDICATION TO ADDRESS THE ISSUE. ALSO, IT WAS NOTED THAT A NEW WAVELET WAS COLLECTED. 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 24560021 ↗
• InjuryDec 10, 2025Pacing 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 ROOM DUE TO SHORTNESS OF BREATH AND DIZZINESS. THE PATIENT HAD BEEN OUT OF THEIR MEDICATION FOR MORE THAN SIX MONTHS. AN ELECTROCARDIOGRAM DEMONSTRATED ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. MEDICATION WAS ADMINISTERED WHICH IMPROVED THE PATIENT'S RATE. THE PATIENT WAS ADMITTED. AN INTERROGATION OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE FOLLOWING DAY INDICATED MULTIPLE INAPPROPRIATE HIGH VOLTAGE THERAPIES AND ANTI-TACHYCARDIA PACING (ATP) FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE WITH PREMATURE VENTRICULAR COMPLEXES AND SUPRA VENTRICULAR TACHYCARDIA (SVT) THAT FELL INTO THE VENTRICULAR TACHYCARDIA (VT)/VENTRICULAR FIBRILLATION (VF) ZONE FROM TWO WEEKS PRIOR. THE PATIENT WAS RESTARTED ON THEIR ANTICOAGULANT FOR AF. THE PATIENT LEFT THE HOSPITAL AGAINST MEDICAL ADVICE PRIOR TO A FINAL CARDIOLOGY EVALUATION. THE PATIENT PRESENTED TO THE EMERGENCY ROOM FIVE MONTHS LATER ANOTHER ICD INTERROGATION INDICATED ATP DELIVERY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE. THE PATIENT'S ATRIAL SENSITIVITY WAS ADJUSTED. THE ICD REMAINS IN USE. THE PATIENT IS A PARTICIPAN

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

  MAUDE report 23767263 ↗
• InjuryAug 21, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE ICD SYSTEM WAS EXPLANTED DUE TO AN INFECTION. A NEW ICD SYSTEM WAS SUBSEQUENTLY IMPLANTED, BUT THE LEADLESS PACEMAKER REMAINS IN THE PATIENT.

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

  MAUDE report 22866931 ↗
• InjuryAug 19, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKED FOR ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) WITH RAPID VENTRICULAR RESPONSE WHICH THE DEVICE DETECTED AND TREATED AS VENTRICULAR TACHYCARDIA (VT). 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 22841855 ↗
• InjuryJul 14, 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 AN INFECTION NEAR THE DEVICE POCKET. THE PATIENT EXPERIENCED REDNESS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Erythema; Medical device site infection

  MAUDE report 22497530 ↗
• InjuryJan 15, 2025Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY FOR ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE THAT WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT). THE DEVICE 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; Shock from Patient Lead(s)

  MAUDE report 21160920 ↗
• InjuryOct 30, 2024Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Pacing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED ANTI-TACHYCARDIA PACING (ATP) AND SHOCK FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) EPISODE DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. THE ICD WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 20566993 ↗
• InjuryOct 29, 2024Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem; Inappropriate/Inadequate Shock/Stimulation; Device Sensing Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) POSSIBLY DELIVERED INAPPROPRIATE SHOCKS FOR SUPRA VENTRICULAR TACHYCARDIA (SVT). THE ICD DETECTED THE EPISODE AS VENTRICULAR FIBRILLATION (VF). IT WAS ALSO NOTED THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING. THE ICD SYSTEM 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 20561432 ↗
• MalfunctionOct 24, 2024Pacing Problem; Pacing Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY EXPERIENCED A HEART RATE LOWER THAN THAT OF THE PROGRAMMED LOWER RATE OF THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE DEVICE REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 20523073 ↗
• InjuryAug 5, 2024Inappropriate/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 DETECTED FAST VENTRICULAR TACHYCARDIA (FVT) THAT WAS POSSIBLY SUPRA VENTRICULAR TACHYCARDIA (SVT). 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 19906294 ↗
• MalfunctionMay 1, 2024Data Problem; Data Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT CLEAR HIGH RATE NON-SUSTAINED EPISODES FROM THE PREVIOUS INTERROGATION. ADDITIONALLY, THE RIGHT ATRIAL (RA) LEAD HAD UNDERSENSING DURING ATRIAL TACHYCARDIA/ATRIAL FIBRILLATION (AT/AF) EVENTS, BUT DID NOT APPEAR TO IMPACT DEVICE FUNCTION OR PERFORMANCE. THE ICD AND 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 19220956 ↗

Other Medtronic, Inc. products

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