FREESTYLE® 995CS21 (UDI 00643169002241)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169002241), received between May 20, 2022 and Jul 18, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Gradient Increase; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Gradient Increase; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF THE SAME EXACT MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343755 ↗
• InjuryMay 20, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 9 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 14454872 ↗