FREESTYLE® FR995-19 (UDI 00643169002098)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00643169002098), received between Dec 8, 2016 and Sep 30, 2026 — classified as 1 death, 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Calcified; Device Stenosis

  It was reported that 11 years and 1 month post implant of this 19mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as aortic stenosis. Evidence of calcification was seen in the sino-tubular junction (STJ). No intervention or adverse patient effects were reported.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 50943946 ↗
• InjuryAug 23, 2026Gradient Increase; Device Stenosis

  It was reported that 4 years and 6 months post implant of this 19mm aortic bioprosthetic valve implanted in the pulmonary position, in a 4 year old pediatric patient, a 16mm pulmonary transcatheter valve was implanted valve-in-valve. The reason for intervention was reported as severe conduit stenosis with peak gradient of 50-55mmHg. It was noted that the reason for replacement was not the result of somatic outgrowth of the original conduit. No additional adverse patient effects were reported.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 50397181 ↗
• InjuryMar 24, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS 19MM FREESTYLE AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. A COMPUTED TOMOGRAPHY WAS CONDUCTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24673122 ↗
• InjuryJul 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 7 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19745604 ↗
• InjuryMay 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 5 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19347510 ↗
• InjuryFeb 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS 19MM BIOPROSTHETIC AORTIC VALVE IMPLANTED IN A (B)(6)-YEAR-OLD PEDIATRIC PATIENT, 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: No Information

  MAUDE report 9769460 ↗
• InjurySep 18, 2019Gradient Increase; Increase in Pressure; Insufficient Device Problem Information; Gradient Increase; Increase in Pressure; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, IMPLANTED IN THE PULMONARY POSITION IN A (B)(6) YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV) WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: High Pulmonary Arterial Wedge Pressure; No Information

  MAUDE report 9083097 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF THE SAME MODEL. THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Corneal Pannus; No Information

  MAUDE report 8431529 ↗
• InjuryFeb 20, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 7 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF THE SAME MODEL.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Corneal Pannus; No Information

  MAUDE report 8356047 ↗
• DeathApr 19, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 7 MONTHS POST IMPLANT OF THIS 23MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 19MM VALVE OF THE SAME MODEL.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR THE VALVE REPLACEMENT WAS THAT A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN AORTIC RUPTURE. EMERGENT SURGERY WAS PERFORMED AND THE 23MM VALVE WAS EXPLANTED AND REPLACED WITH A 19MM VALVE OF THE SAME MODEL. THE PHYSICIAN REPORTED THAT THE PATIENT WAS UNABLE TO BE WEANED OFF OF CARDIOPULMONARY BYPASS (CPB) AND THE STATED CAUSE OF DEATH WAS PERSISTENT BLEEDING.

  Patient problems: Blood Loss; Death; Rupture

  MAUDE report 7442576 ↗
• InjuryOct 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY FOUR YEARS AND NINE MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS REPLACED VALVE-IN-VALVE WITH A MEDTRONIC TRANSCATHETER VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; No Information

  MAUDE report 6970418 ↗
• InjuryDec 8, 2016Structural Problem; Insufficient Device Problem Information; Structural Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY THREE YEARS, THREE MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, THIS VALVE WAS REPLACED, VALVE-IN-VALVE WITH A TRANSCATHETER BIOPROSTHETIC VALVE. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation; Dyspnea; No Information

  MAUDE report 6156550 ↗