FREESTYLE® 995MS21Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00721902316159), received between Apr 4, 2023 and Apr 4, 2023 — classified as 1 death.

The most frequently reported specific device problem is “Calcified” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathApr 4, 2023Calcified; Gradient Increase; Calcified; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 1 MONTH POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION. IT WAS REPORTED THAT FOUR DAYS LATER, THE PATIENT DIED. THE CAUSE OF DEATH WAS ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC CONGESTIVE HEART FAILURE AND FLASH PULMONARY EDEMA RELATED TO SEVERE VALVULAR HEART DISEASE. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING SEVERE DEGENERATIVE, SYMPTOMATIC BIOPROSTHETIC AORTIC VALVE STENOSIS WITH A MEAN GRADIENT OF 46MMHG AND FLOW VELOCITY OF 4.3M/S. IT WAS STATED THAT SEVERE AORTIC VALVULAR CALCIFICATION AND PROXIMAL AORTIC ROOT CALCIFICATION WERE OBSERVED ON COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA).

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification; Heart Failure/Congestive Heart Failure; Pulmonary Edema

  MAUDE report 16675092 ↗