MOSAIC ULTRA® 305U225 (UDI 00643169001527)Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00643169001527), received between Feb 23, 2017 and Sep 25, 2026 — classified as 31 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (21 reports).

3 other recalls cover devices cleared under the same FDA submission (P990064); they may or may not involve this specific model.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Device Stenosis

  It was reported that 10 years and 1 month post implant of this 25mm 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 moderate calcium was seen in the valve leaflet. No intervention or adverse patient effects were reported.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50895141 ↗
• InjurySep 21, 2026Insufficient Device Problem Information

  Medtronic received information that 11 years and 7 months post implant of this 25mm aortic bioprosthetic valve, a 26mm aortic 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 50836460 ↗
• MalfunctionJun 30, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25 MM MOSAIC 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 25665410 ↗
• MalfunctionJan 27, 2026Device Stenosis

  IT WAS REPORTED THAT 10 YEARS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24187907 ↗
• MalfunctionOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM AORITC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE FAILED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23367344 ↗
• InjuryOct 21, 2025Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 10 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY AND AORTIC STENOSIS. EVIDENCE OF CALCIFICATION SEEN IN LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE LEFT CORONARY CUSP (LCC), NON-CORONARY CUSP (NCC), RIGHT CORONARY CUSP (RCC) AND IN PROXIMAL LEFT CORONARY ARTERY AND RIGHT CORONARY ARTERY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23348490 ↗
• InjuryJun 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 22168492 ↗
• InjuryMay 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 11 MONTHS POST IMPLANT OF THIS 25MM MOSAIC AORTIC VALVE , A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIO-VENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22088134 ↗
• InjuryApr 22, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS MOSAIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR IN TERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21882258 ↗
• InjuryApr 18, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR EVALUATION AS SEVERE AORTIC REGURGITATION. SUBSEQUENTLY, 26 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 21867093 ↗
• InjuryMar 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 25MM MOSAIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A DEVICE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21651383 ↗
• InjuryJan 29, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 21265301 ↗
• MalfunctionJan 22, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS 25MM 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 A MEAN GRADIENT OF 38MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21206090 ↗
• InjuryJan 10, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF A MOSAIC AORTIC VALVE, A PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21122994 ↗
• InjuryJan 10, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A MOSAIC AORTIC TISSUE VALVE SUBSEQUENTLY UNDERWENT A TRANSCATHETER AORTIC VALVE-IN-VALVE REPLACEMENT PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21122589 ↗
• MalfunctionDec 3, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION FROM A PATIENT REPRESENTATIVE THAT 7 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS A LEAK THAT HAS REACHED UP TO "45% ON THE INSIDE OF THE VALVE." IT WAS FURTHER SPECIFIED THAT THE REASON FOR EVALUATION IS SEVERE AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20834441 ↗
• InjuryOct 29, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 1 MONTH POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20558765 ↗
• InjuryJul 22, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS) AND MODERATE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19796845 ↗
• InjuryFeb 2, 2024Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT 20 DAYS LATER, THE PATIENT HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18632478 ↗
• InjuryDec 18, 2023Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18343302 ↗
• InjuryNov 15, 2023Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 9 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS STENOSIS AND SEVERE AORTIC INSUFFICIENCY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 16 DAYS LATER, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A 26MM TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18140645 ↗
• InjuryApr 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED TO BE DUE TO VALVE FAILURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 14022142 ↗
• InjuryJul 9, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A 26MM TRANSCATHETER AORTIC VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 12141916 ↗
• InjuryJul 1, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE VALVE WAS REPLACED DUE TO PATIENT-PROSTHESIS MISMATCH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12100814 ↗
• InjuryJun 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM BIOPROSTHETIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 11983169 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990064. One submission often covers many models, so check the product and lot details in each record.

• Z-1881-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1880-2019 · May 21, 2019 · Terminated
  Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.
• Z-1225-2009 · Jan 26, 2009 · Terminated
  Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Medtronic Inc 710 M