Revo MRI SureScanRecalls & reported problems across all models

We found 2 models of Revo MRI SureScan by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 762 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2013 and Aug 11, 2026 — classified as 6 deaths, 463 injuries, 293 malfunctions.

The most frequently reported specific device problem is “Reset Problem” (150 reports).

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

Most reported Revo MRI SureScan problems

Revo MRI SureScan models

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

• Revo MRI™ SureScan™ RVDR01

  Pulse generator, permanent, implantable
  4 deaths721 reports
• Revo MRI™ SureScan™ RVDR01

  Pulse generator, permanent, implantable
  2 deaths41 reports

Recent Revo MRI SureScan adverse event reports

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

• MalfunctionAug 11, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208838 ↗
• MalfunctionJul 10, 2026Failure to Interrogate

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25778440 ↗
• MalfunctionMay 29, 2026Pacing Problem

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDER SENSING DURING AT/AF STORED EPISODES RESULTING IN TERMINATION OF AT/AF DETECTED EVENT(S) IN PROGRESS AND MISCLASSIFICATION OF EPISODE. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED SPIKES SEEN WITHIN THE QRS COMPLEX ON TELEMETRY. THE SYSTEM 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 25329213 ↗
• MalfunctionApr 23, 2026Electromagnetic Interference

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED DIZZINESS AND PRE SYNCOPE. IT WAS FURTHER REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED OVERSENISNG AND NOISE. IT WAS FURTHER REPORTED THAT ELECTROMAGNETIC INTERFERENCE (EMI) WAS NOTED ON THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD AND IPG 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 24966891 ↗
• MalfunctionMar 25, 2026Migration or Expulsion of Device

  IT WAS REPORTED BY THE PATIENT THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAS "MOVED" AND IS "CLOSER TO BEING UNDER THEIR ARM THAN WHERE IT WAS ORIGINALLY." THE IPG 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 24685053 ↗
• InjuryMar 18, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT HAD A SYNCOPAL EPISODE WHEN THEIR IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED AND REPLACED DUE TO NORMAL END OF SERVICE (EOS). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 24625547 ↗
• InjuryJan 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEIR IMPLANTABLE PULSE GENERATOR (IPG) WAS "BULGES OUT", THUS REQUIRING IT TO BE EXPLANTED AND REPLACED. 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 24188177 ↗
• InjuryNov 26, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. IT WAS ALSO REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) WAS AT END OF SERVICE (EOS). THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 23656006 ↗
• InjurySep 8, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SYNCOPE. THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED END OF SERVICE (EOS);AND WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Syncope/Fainting

  MAUDE report 22992362 ↗
• MalfunctionSep 8, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THEY WERE UNABLE TO CONFIRM CAPTURE ON ATRIAL LEAD ON CURRENT ELECTROGRAMS (EGM). THE IMPLANTABLE PULSE GENERATOR (IPG) 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 22990771 ↗
• MalfunctionAug 27, 2025Pacing Problem; Pacing Problem

  IT WAS REPORTED THAT THERE WAS LOSS OF CAPTURE NOTED ON EXTERNAL TELEMETRY, WITH PATIENT HEART RATE INTO THE FORTIES. IT WAS FOUND THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD REACHED END OF SERVICE (EOS). IN ADDITION, THE RIGHT ATRIAL (RA) LEAD EXHIBITED A VARIATION AND AN INCREASE IN LEAD IMPEDANCES NOTED ON LEAD TRENDS AND ATRIAL CAPTURE COULD NOT BE CONFIRMED. THE IPG WAS EXPLANTED AND REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR (ERI). THE RA LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Bradycardia

  MAUDE report 22903361 ↗
• InjuryAug 18, 2025Premature Discharge of Battery; Premature Discharge of Battery

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXHIBITED 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 22826547 ↗
• InjuryJul 9, 2025Reset Problem; Reset Problem

  IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) THE IPG WAS EXPLANTED AND RE PLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22455747 ↗
• InjuryJul 3, 2025Premature Discharge of Battery; Premature Discharge of Battery

  THE PATIENT REPORTED THAT THEY WERE TOLD BY THERE DOCTOR THAT THEIR "DEVICE IS ALREADY LOW IN BATTERY".  THE IMPLANTABLE PULSE GENERATOR (IPG) 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 22392576 ↗
• InjuryMay 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS FURTHER REPORTED THAT THE IPG HAD REACHED RECOMMENDED REPLACEMENT TIME (RRT) AND WAS EXPLANTED AND REPLACED WITH A CARDIAC RE SYNCHRONIZATION THERAPY PACEMAKER (CRT-P) AS AN UPGRADE.

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

  MAUDE report 22112648 ↗

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