FREESTYLE® 995CS27 (UDI 00643169002302)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169002302), received between May 23, 2017 and Apr 26, 2018 — classified as 2 deaths, 1 injury.

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

• DeathApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS POST IMPLANT OF THESE BIOPROSTHETIC VALVES, THE PATIENT DIED. THE CAUSE OF DEATH WAS REPORTED AS MULTI-ORGAN FAILURE. THERE WAS NO ALLEGATION THAT THE VALVES CONTRIBUTED TO THE PATIENT'S DEATH. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED OR IF THE DEVICES WERE EXPLANTED.

  Patient problems: Death; Multiple Organ Dysfunction Syndrome

  MAUDE report 7464000 ↗
• InjuryJan 26, 2018Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 27MM BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF THE SAME MODEL DUE TO PARAVALVULAR LEAK. THE PATIENT WAS REPORTED TO BE STABLE AFTER A SUCCESSFUL VALVE IMPLANT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7221888 ↗
• DeathMay 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING IMPLANT OF THIS BIOPROSTHETIC VALVE THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. NO AUTOPSY WAS PROVIDED.

  Patient problems: Death

  MAUDE report 6583768 ↗