FREESTYLE® 995CS25 (UDI 00643169002289)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169002289), received between Aug 21, 2023 and Jul 16, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 WEEKS POST IMPLANT OF THIS FREESTYLE VALVE, A LEADLESS PACEMAKER WAS IMPLANTED. THE REASON FOR THE LEADLESS PACEMAKER WAS REPORTED AS BRADY/TACHY SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Tachycardia

  MAUDE report 22517209 ↗
• InjuryAug 21, 2023Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 9 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS PERIVALVULAR LEAK RESULTING IN SEVERE AORTIC REGURGITATION. IT WAS REPORTED THAT DURING THE EXPLANT PROCEDURE, THE VALVE WAS INSPECTED AND IT APPEARED TO HAVE PULLED OFF FROM THE AORTIC WALL AT THE SITE OF A PREVIOUS AORTIC ABSCESS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17587336 ↗