FREESTYLE® 995CS23 (UDI 00681490219112)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00681490219112), received between Nov 19, 2018 and May 25, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 5 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17006175 ↗
• InjuryJun 2, 2020Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 4 MONTHS POST IMPLANT OF THIS 23MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation; Congestive Heart Failure; No Information

  MAUDE report 10111042 ↗
• InjuryDec 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 8180806 ↗
• InjuryDec 11, 2018Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 3 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS CAUSED BY CALCIFIED LEAFLETS. MODERATE INSUFFICIENCY WAS ALSO REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 8150736 ↗
• InjuryNov 19, 2018Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 2 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE VALVE WAS REPLACED DUE TO HIGH GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8086382 ↗