FREESTYLE® FR995-27 (UDI 00681490265942)Recalls & reported problems

Summary

The FDA's MAUDE database contains 318 adverse event reports that list this exact device (DI 00681490265942), received between Dec 13, 2016 and Jul 30, 2026 — classified as 2 deaths, 309 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (250 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 318 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  Additional Information received reported that on (b)(6), 2026, during intubation the patient coded and was not able to be resuscitated. The cause of death was not received. It was reported the death was not related to the freestyle valve. It is unknown whether an autopsy was performed.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Cardiac Arrest

  MAUDE report 50084682 ↗
• InjuryOct 22, 2025Patient Device Interaction Problem; Intravalvular regurgitation; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 5 MONTHS POST IMPLANT OF THIS FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. IT WAS REPORTED THAT A TRANSTHORACIC ECHOCARDIOGRAM PERFORMED NOTED SEVERE AORTIC INSUFFICIENCY, MEAN GRADIENT OF 11MMHG, LEFT VENTRICULAR EJECTION FRACTION OF 45% AND HEART FAILURE WITH REDUCED EJECTION FRACTION. IT WAS STATED THAT EVIDENCE OF NEAR CONCENTRIC CALCIFICATION WAS SEEN IN THE SINOTUBULAR JUNCTION (STJ). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23359283 ↗
• InjurySep 16, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 3 MONTHS POST IMPLANT OF THIS FREESTYLE AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. INTERVENTION IS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 23060807 ↗
• InjurySep 10, 2025Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 9 MONTHS POST IMPLANT OF THIS FREESTYLE AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY (AI) DUE TO A TORN LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23019382 ↗
• InjurySep 8, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 13 YEARS AND 7 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 22991600 ↗
• InjuryAug 11, 2025Calcified; Intravalvular regurgitation; Calcified; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REASON FOR INTERVENTION WAS MODERETE-SEVERE AORTIC REGURGITATION. NO ADDITIONAL AD VERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification

  MAUDE report 22774283 ↗
• MalfunctionAug 6, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 2 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVAL UATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC STENOSIS AND A PEAK VELOCITY OF 4.3M/S. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22724347 ↗
• InjuryJul 16, 2025Material Split, Cut or Torn; Intravalvular regurgitation; Material Split, Cut or Torn; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS A TORN LEAFLET AND SEVERE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Cusp Tear

  MAUDE report 22519510 ↗
• InjuryMay 9, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF THIS FREESTYLE AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21993722 ↗
• InjuryMay 8, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVA LUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION. IT WAS REPORTED THAT AN INTERVENTION IS SCHEDULED FOR (B)(6) 2025 WITH A NON-MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21987433 ↗
• InjuryMay 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21962563 ↗
• InjuryApr 25, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 18 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC INSUFFICIENCY AND A FLAIL LEFT LEAFLET. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21909312 ↗
• InjuryMar 13, 2025Material Split, Cut or Torn; Device Stenosis; Material Split, Cut or Torn; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS AND POSSIBLE TORN NON-CORONARY CUSP. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 9 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21596159 ↗
• InjuryMar 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AFTER AN UNKNOWN DURATION POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21536645 ↗
• InjuryMar 3, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS POST IMPLANT OF THIS 27MM FREESTYLE VALVE, IT WAS EXPLANTED AND REPLACED WITH A COMPETITORS VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21503553 ↗
• InjuryFeb 10, 2025Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation; Gradient Increase; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE AORTIC REGURGITATION, A PEAK GRADIENT OF 37MMHG AND AN EJECTION FRACTION OF 50-55%. IT WAS ALSO REPORTED THAT THE PATIENT HAD SYMPTOMS OF DYSPNEA ON EXERTION AND LIGHTHEADEDNESS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Dyspnea

  MAUDE report 21351268 ↗
• InjuryJan 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. IT WAS REPORTED THAT THE PATIENT HAD SYMPTOMS OF SHORTNESS OF BREATH AND OTHER UNKNOWN SYMPTOMS THAT DID NOT APPEAR DIRECTLY RELATED TO THE DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 21159079 ↗
• MalfunctionDec 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20845066 ↗
• InjuryDec 2, 2024Calcified; Calcified

  IT WAS REPORTED THAT A 27MM FREESTYLE AORTIC VALVE IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. IT WAS STATED THAT ANNULAR CALCIFICATION WAS SEEN UNDER THE RIGHT CORONARY CUSP (RCC). IT WAS FURTHER STATED THAT A POSSIBLE DISSECTION WAS SEEN IN THE NON-CORONARY CUSP (NCC) AND IN THE ASCENDING AORTA ABOVE THE RIGHT CORONARY CUSP (RCC) AND LEFT CORONARY CUSP (LCC). THE DEVICE REMAINS IMPLANTED AND IN SERVICE.

  Patient problems: Calcium Deposits/Calcification; Vascular Dissection

  MAUDE report 20818384 ↗
• MalfunctionNov 6, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 13 YEARS AND 1 MONTH POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE THAT THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS AND AORTIC REGURGITATION OF UNKNOWN SEVERITY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20623135 ↗
• InjuryOct 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 3 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20544776 ↗
• InjuryOct 22, 2024Calcified; Device Stenosis; Calcified; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS (AS) DUE TO CALCIFICATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, ONE DAY LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20507097 ↗
• InjuryOct 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20465635 ↗
• InjuryOct 15, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A BI-VENTRICULAR DE FIBRILLATOR WAS IMPLANTED. THE REASON FOR THE BI-VENTRICULAR DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20451907 ↗
• InjuryOct 15, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 4 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIO-VENTRICULAR BLOCK (AVB) AND ATRIAL ARRHYTHMIAS INDICATED AS BEING ATRIAL FIBRILLATION (AFIB), ATRIAL FLUTTER AND ATRIAL TACHYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 20451888 ↗