MOSAIC ULTRA® 305U225 (UDI 00643169594968)Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 00643169594968), received between Feb 1, 2017 and Sep 18, 2026 — classified as 3 deaths, 59 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (41 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Insufficient Device Problem Information; Device Stenosis

  Medtronic received information that for an unknown duration 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 not reported. No intervention or adverse patient effects were reported.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 50814679 ↗
• MalfunctionMar 23, 2026Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR THE EVALUATION WAS REPORTED AS STENOSIS AND SHORTNESS OF BREATH OR DYSPNEA ON EXERTION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Dyspnea; Insufficient Information

  MAUDE report 24661099 ↗
• MalfunctionMar 13, 2026Device Stenosis

  IT WAS REPORTED THAT 5 YEARS AND 10 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. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24590389 ↗
• InjuryJan 28, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SUFFERED FROM PRE-EXISTING ARRHYTHMIAS (AV BLOCK/LBBB) PRIOR TO THE HEART VALVE IMPLANT AND THAT THE PHYSICIAN DOES NOT BELIEVE THE HEART VALVE OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE CONDUCTION DISTURBANCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24199813 ↗
• InjuryJan 23, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 3 YEARS AND 10 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 NOT REPORTED. IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24161611 ↗
• InjuryDec 30, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED ANOTHER REASON FOR EVALUATION WAS MEAN GRADIENT OF 21MMHG. IT WAS ALSO REPORTED THAT POST IMPLANT THE MEAN GRADIENT WAS 3-4 MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23919952 ↗
• InjuryDec 15, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT 7 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC AORTIC MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. IT WAS ALSO STATED THAT THE VALVE DISINTEGRATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23802324 ↗
• InjuryNov 20, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 2 YEARS AND 3 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS SYNCOPE WITH INDUCIBLE VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Syncope/Fainting; Tachycardia; Ventricular Fibrillation

  MAUDE report 23604939 ↗
• InjuryNov 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON DECEMBER 17, 2025, THE PATIENT SUCCESSFULLY HAD A 26MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23593668 ↗
• InjuryOct 15, 2025Perivalvular Leak; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Perivalvular Leak; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT, 5 WEEKS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INT ERVENTION WAS REPORTEDAS AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23301237 ↗
• InjurySep 17, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT 1 YEAR AND 9 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE IT EXPERIENCED A VALVE PERFORMANCE ISSUE AND VALVE STENOSIS. A REDO AORTIC VALVE REPLACEMENT WITH A MECHANICAL VALVE WAS PLANNED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23072826 ↗
• InjuryJul 28, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS MOSAIC AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS (AS) AND HIGH GRADIENT. SHORTNESS OF BREATH (SOB) WAS ALSO REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 22629177 ↗
• InjuryJul 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE INFECTION TO BE ENDOCARDITIS. IT WAS ALSO REPORTED THAT THE CAUSE OF ENDOCARDITIS IS SUSPECTED TO BE FROM A URINARY TRACT INFECTION (UTI) THAT SEEDED THE BLOODSTREAM. THE ORGANISM IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Unspecified Infection; Urinary Tract Infection

  MAUDE report 22436146 ↗
• InjuryJul 2, 2025Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS A LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 22382800 ↗
• InjuryJun 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A 25MM MOSAIC SURGICAL VALVE EXPERIENCED A VALVE PERFORMANCE ISSUE AND VALVE DYSFUNCTION. SUBSEQUENTLY 25 DAYS LATER, THE PATIENT SUCCESSFULLY HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 22298373 ↗
• InjuryJun 3, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 1 MONTH POST IMPLANT OF THIS 25MM MOSAIC AORTIC 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 Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 22130409 ↗
• InjuryMay 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 25MM MOSAIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22050890 ↗
• MalfunctionFeb 18, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 25MM MOSAIC ULTRA VALVE IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21395972 ↗
• MalfunctionJan 16, 2025Calcified; Calcified

  MEDTRONIC RECEIVED INFORMATION THAT 7 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. IT WAS REPORTED THAT DURING EVALUATION CALCIUM COULD BE SEEN UNDER THE NON-CORONARY CUSP EXTENDING IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 21171886 ↗
• MalfunctionDec 6, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS 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 REGURGITATION (AR). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20872563 ↗
• MalfunctionDec 6, 2024Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 1 MONTH AND 8 DAYS 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 PARAVALVULAR LEAK OF UNKNOWN SEVERITY. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 20872401 ↗
• MalfunctionDec 6, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 2 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 LEAFLET THICKENING, AORTIC STENOSIS (AS) AND AORTIC INSUFFICIENCY (AI). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20870817 ↗
• MalfunctionDec 4, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AFTER PREPARATION OF A 25MM MOSAIC ULTRA AORTIC VALVE, AN ANIMAL HAIR WAS FOUND ON THE VALVE WHEN IT WAS ABOUT TO BE IMPLANTED. THE VALVE WAS NOT IMPLANTED DUE TO CONCERNS OF CONTAMINATION. THE VALVE HAD BEEN INSPECTED PRIOR TO USE. THE HEALTHCARE TEAM DECIDED TO USE ANOTHER IDENTICAL VALVE TO COMPLETE THE PROCEDURE. THERE WERE NO COMPLICATIONS REPORTED AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842552 ↗
• MalfunctionOct 21, 2024Calcified; Device Stenosis; Calcified; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 6 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 SEVERE AORTIC STENOSIS (AS). IT WAS NOTED THAT CALCIFICATION WAS PRESENT IN THE PROXIMAL RCA (RIGHT CORONARY ARTERY). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 20492297 ↗
• MalfunctionOct 1, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20342193 ↗

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