MOSAIC ULTRA® 305U227 (UDI 00643169001503)Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00643169001503), received between Aug 8, 2017 and Sep 17, 2026 — classified as 77 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (48 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 84 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Device Stenosis; Intravalvular regurgitation

  Medtronic received information that 10 years and 7 months post implant of this 27mm Mosaic aortic bioprosthetic valve, a transcatheter valve was implanted valve-in-valve. The reason for intervention was reported as severe aortic regurgitation (AR) and moderate aortic stenosis (AS). No additional adverse patient effects were reported.

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

  MAUDE report 50804044 ↗
• InjuryJun 19, 2026Device Stenosis

  IT WAS REPORTED THAT 12 YEARS AND 11 MONTHS POST OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS VALVE STENOSIS. IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADDITIONAL OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25558834 ↗
• InjuryJun 4, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 3 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 25390955 ↗
• MalfunctionMay 27, 2026Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS POST IMPLANT OF THIS 27MM MOSAIC AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS CONGESTIVE HEART FAILURE (CHF) AND AORTIC STENOSIS (AS). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 25300662 ↗
• InjuryMay 19, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 10 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. SUBSEQUENTLY ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD A 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25218457 ↗
• MalfunctionApr 27, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT 13 YEARS AND 4 MONTHS OF THIS MOSAIC 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 24998414 ↗
• InjuryMar 20, 2026Gradient Increase; Intravalvular regurgitation

  IT WAS REPORTED THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION, ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR), EJECTION FRACTION OF 56% AND A MEAN GRADIENT OF 9 MMHG. SUBSEQUENTLY ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. IT WAS FURTHER NOTED POST PROCEDURE, ECHOCARDIOGRAM SHOWED PATIENT HAD NO EVIDENCE OF AORTIC REGURGITATION AND A MEAN GRADIENT OF 4 MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Atrial Fibrillation

  MAUDE report 24647424 ↗
• InjuryMar 11, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 11 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. SUBSEQUENTLY ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD A 29MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24567292 ↗
• InjuryFeb 24, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR THE INTERVENTION WAS SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24428651 ↗
• InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 11 YEARS AND 9 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC 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 24128779 ↗
• InjuryDec 22, 2025Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 4 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 INSUFFICIENCY AND AORTIC STENOSIS, AS WELL AS INCREASED GRADIENTS OF 32MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873304 ↗
• InjuryJul 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 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: Insufficient Information

  MAUDE report 22564799 ↗
• InjuryMay 28, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 3 MONTHS POST IMPLANT OF THIS 27MM MOSAIC AORTIC 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. SUBSEQUENTLY, ONE WEEK LATER, 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 22096301 ↗
• InjuryMay 15, 2025Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED A TAV IN SAV INTERVENTION IS SCHEDULED TO OCCUR. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 22026374 ↗
• InjuryMay 6, 2025Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  IT WAS REPORTED THAT THE VALVE 305U227 MOS AOR CINCHII ULTRA 27 EXPERIENCED LEAFLET PROLAPSE, VALVE PERFORMANCE ISSUES/DYSFUNCTION, AND POOR COAPTATION OF THE VALVE LEAFLETS. THERE WAS A PLANNED TREATMENT/INTERVENTION OF THE MEDTRONIC VALVE, ALTHOUGH IT WAS NOT SCHEDULED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 21969832 ↗
• InjuryMar 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 10 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21512616 ↗
• MalfunctionMar 3, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS 27MM 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: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21502746 ↗
• InjuryFeb 25, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT 4 DAYS LATER, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A NON MEDTRONIC TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21456157 ↗
• InjuryFeb 21, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 11 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE THAT THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY (AI). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21434065 ↗
• InjuryFeb 13, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 27MM MOSAIC AORTIC VALVE EXHIBITED SEVERE CENTRAL AORTIC INSUFFICIENCY WITH AN UNKNOWN SEVERITY OF PERIVALVULAR LEAK. A TRANSCATHETER VALVE-IN-VALVE (VIV) REPLACEMENT PROCEDURE WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE WELL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 21374453 ↗
• MalfunctionFeb 6, 2025Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION 10 YEARS AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE THAT THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS HIGH GRADIENTS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21326984 ↗
• InjuryFeb 3, 2025Gradient Increase; Mechanics Altered; Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Gradient Increase; Mechanics Altered; Insufficient Device Problem Information; Thickening of Material; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 10 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21294603 ↗
• InjuryJan 29, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A MOSAIC AORTIC VALVE WAS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT DUE TO AORTIC STENOSIS. SUBSEQUENTLY, 1 WEEK LATER, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE-IN-VALVE REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED .

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21261967 ↗
• InjuryDec 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS CARDIOMYOPATHY AND PRIMARY PREVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 20895759 ↗
• InjuryDec 6, 2024Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, 1 MONTH AND 19 DAYS LATER, A TRANSCATHETER VALVE OF A DIFFERENT MANUFACTURER WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20863214 ↗

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-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-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-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