FREESTYLE® 995MS25 (UDI 00721902316173)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00721902316173), received between Jul 23, 2018 and Nov 14, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 12 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20686552 ↗
• InjuryNov 12, 2024Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 24 DAYS LATER, A 26MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS), MODERATE AORTIC REGURGITATION (AR) AND A GRADIENT OF 31MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis

  MAUDE report 20661971 ↗
• InjurySep 29, 2023Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 19 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 17841719 ↗
• InjuryMay 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 10088186 ↗
• InjuryApr 23, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, AN ATTEMPT WAS MADE TO IMPLANT A TRANSCATHETER AORTIC VALVE (TAV) DUE TO AORTIC INSUFFICIENCY, BUT WAS UNSUCCESSFUL AND THE VALVE WAS SURGICALLY REMOVED AN REPLACED. THE REPLACEMENT VALVE WAS NOT SPECIFIED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 9990785 ↗
• InjuryAug 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 8 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT WAS UNDERGOING A MITRAL VALVE REPLACEMENT SO THE PHYSICIAN DECIDED TO REPLACE THE AORTIC VALVE DURING THE SAME PROCEDURE. THE AORTIC BIOPROSTHETIC VALVE WAS REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL DUE TO MODERATE STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 7769989 ↗
• InjuryJul 23, 2018Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO A TORN LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cusp Tear; No Code Available

  MAUDE report 7711078 ↗