FREESTYLE® 995MS29 (UDI 00721902316197)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00721902316197), received between Dec 15, 2017 and Jan 7, 2026 — classified as 1 death, 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 YEARS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SYNCOPE AND SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes; Syncope/Fainting

  MAUDE report 23988229 ↗
• MalfunctionSep 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 7 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20232433 ↗
• InjuryNov 1, 2023Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 11 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SIGNIFICANT REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18045749 ↗
• InjuryAug 23, 2023Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM AORTIC BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MODERATE TO SEVERE AORTIC INSUFFICIENCY SECONDARY TO SEVERAL PARAVALVULAR LEAKS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17602648 ↗
• InjuryJan 12, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS MODERATE AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 18 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 16145364 ↗
• InjuryJun 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED TO BE DUE TO SEVERE AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, ONE DAY LATER, IT WAS REPORTED THAT THE VALVE-IN-VALVE REPLACEMENT WAS PERFORMED WITH A NON-MDT DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 14565169 ↗
• InjuryOct 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12657885 ↗
• InjuryMay 5, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 10 MONTHS POST IMPLANT OF THIS 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: Aortic Insufficiency; Aortic Valve Stenosis; No Information

  MAUDE report 10025449 ↗
• InjuryMay 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 29MM BIOPROSTHETIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation

  MAUDE report 8646204 ↗
• InjuryMay 1, 2019Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, IT WAS REPLACED VALVE-IN-VALVE DUE TO CALCIFICATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8568961 ↗
• InjuryApr 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 10 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED DUE TO SEVERE INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 8556228 ↗
• InjuryApr 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 8 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER VALVE DUE TO SEVERE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation

  MAUDE report 8549826 ↗
• InjuryDec 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS 6 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE DUE TO SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 8181567 ↗
• DeathAug 6, 2018Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS 8 MONTHS POST IMPLANT OF THIS 29 MM AORTIC BIOPROSTHETIC VALVE IT WAS EXPLANTED AND REPLACED WITH A 29 MM AORTIC BIOPROSTHETIC VALVE. THE PATIENT HAD ENDOCARDITIS 9 YEARS POST IMPLANT, WHICH LEFT THEM WITH SEVERE AORTIC INSUFFICIENCY AND AORTIC PSEUDO ANEURYSM ALONG WITH CALCIFICATION OF THE AORTIC ROOT AND VALVE. THE PATIENTS POST OP HEMODYNAMICS REQUIRED HIM TO BE SENT TO THE INTENSIVE CARE UNIT (ICU) WITH A BALLOON PUMP AND THE CHEST WAS LEFT OPEN AS THE PATIENT WAS CRITICALLY ILL AND NOT A CANDIDATE FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). ULTIMATELY THE PATIENT HAD VASOPLEGIA WHICH IS LOW SYSTEMIC VASCULAR RESISTANCE LEADING TO HYPOTENSION AND THE PATIENT DIED THAT DAY. THE PHYSICIAN DOES NOT BELIEVE THE VALVE CONTRIBUTED TO THE CAUSE OF DEATH.

  Patient problems: Aortic Insufficiency; Calcium Deposits/Calcification; Death; Endocarditis; Low Blood Pressure/ Hypotension; Pseudoaneurysm

  MAUDE report 7754248 ↗
• InjuryDec 15, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 7 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A VALVE OF SAME SIZE AND MODEL DUE TO A TORN LEAFLET AND SEVERE REGURGITATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation; Cusp Tear

  MAUDE report 7121856 ↗