MOSAIC ULTRA® 305U225 (UDI 00643169001534)Recalls & reported problems

Summary

The FDA's MAUDE database contains 151 adverse event reports that list this exact device (DI 00643169001534), received between Mar 16, 2017 and Jul 30, 2026 — classified as 3 deaths, 138 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (90 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 151 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  It was reported that 10 years and 11 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 paravalvular leak, aortic central regurgitation and severe aortic stenosis. No intervention or adverse patient effects were reported.

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

  MAUDE report 50087944 ↗
• MalfunctionMay 14, 2026Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 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 ELEVATED PROSTHETIC AORTIC VALVE GRADIENT. IT WAS REPORTED THAT THE MEAN GRADIENT WAS 22 MMHG, PEAK GRADIENT WAS 47 MMHG AND AORTIC VALVE VELOCITY WAS 3.43 M/S. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25173230 ↗
• MalfunctionMay 13, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AN UNKNOWN DURATION 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 25159881 ↗
• InjuryApr 21, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR EVALUATION WAS AORTIC STENOSIS. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24938625 ↗
• InjuryApr 3, 2026Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT 10 YEARS AND 3 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: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 24776010 ↗
• InjuryMar 26, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 10 YEARS AND 4 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 REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24696698 ↗
• InjuryMar 24, 2026Gradient Increase; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ON (B)(6) 2026 DISCOVERED MEAN GRADIENT OF 46MMHG AND 29.4MMHG, PEAK VELOCITY OF 4.6 M/S AND 3.6M/S, EJECTION FRACTION OF 55-60%, AORTIC VALVE AREA OF 1.2CM2, MILD MITRAL AND MILD TRICUSPID REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24674277 ↗
• InjuryMar 19, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 13 YEARS AND 3 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 VALVE PERFORMANCE ISSUE "DEGENERATION". IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24638520 ↗
• InjuryMar 18, 2026Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT 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; Insufficient Information

  MAUDE report 24629597 ↗
• InjuryFeb 27, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 3 DAYS LATER, 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 24474572 ↗
• InjuryFeb 24, 2026Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED ANOTHER REASON FOR EVALUATION WAS MODERATE 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; Apnea; Cardiac Arrest; Dyspnea; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24428561 ↗
• InjuryFeb 16, 2026Gradient Increase; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 12 YEARS AND 3 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: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 24344941 ↗
• InjuryJan 21, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 14 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 REGURGITATION. EVIDENCE OF CALCIFICATION WAS SEEN IN THE RIGHT CORONARY ARTERY (RCA). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24130282 ↗
• InjuryJan 19, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 2 MONTHS 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 24107027 ↗
• InjuryJan 5, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 9 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 CENTRAL AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23958698 ↗
• InjuryDec 29, 2025Gradient Increase; Intravalvular regurgitation; Gradient Increase; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED ON FEBRUARY 19, 2026 THE PATIENT SUCCESSFULLY HAD A 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. IT WAS NOTED POST PROCEDURE THE MEAN GRADIENT WAS NOTED TO BE 8MM HG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23905013 ↗
• InjuryDec 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 7 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: Insufficient Information

  MAUDE report 23804255 ↗
• InjuryDec 10, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED ON JANUARY 09, 2026, THE PATIENT SUCCESSFULLY HAD 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23766961 ↗
• InjuryDec 8, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS REPORTED AS LOW EJECTION FRACTION (EF), AND ATRIAL ARRYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF), AND ATRIAL FLUTTER (A-FL)) AND NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASSIFICATION CLASS II. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Tachycardia

  MAUDE report 23742810 ↗
• InjuryDec 8, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD AN AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23742735 ↗
• InjuryNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 12 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 23508477 ↗
• InjuryOct 15, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR EVALUATION AS MODERATE AORTIC STENOSIS AND AN EJECTION FRACTION OF 30-35%. IT WAS FURTHER NOTED THAT THE PATIENT WAS PREVIOUSLY HOSPITALIZED 5 DAYS PRIOR TO THE REPLACEMENT EVALUATION FOR UNSTABLE ANGINA. THE PATIENT WAS THEN ADMITTED, AND A STENT IMPLANT PROCEDURE WAS PERFORMED. A STENT WAS PLACED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE RIGHT CORONARY ARTERY (RCA). THE PATIENT ALSO HAS CORONARY ARTERY DISEASE (CAD), WHICH IS FELT TO BE THE REASON FOR THE UNSTABLE ANGINA. THE PATIENT IS SCHEDULED FOR FOLLOW-UP IN 1 MONTH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Angina; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 23289517 ↗
• InjuryAug 11, 2025Gradient Increase; Intravalvular regurgitation; Gradient Increase; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SEVERITY OF THE REGURGITATION IS UNKNOWN AND THE LEVEL OF GRADIENT WAS 75MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22775342 ↗
• InjuryAug 11, 2025Calcified; Intravalvular regurgitation; Calcified; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 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 REPORTED AS MODERATE AORTIC REGURGITATION. CALCIFICATION WAS ALSO NOTED IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE LEFT CORONARY CUSP AND RIGHT CORONARY CUSP. 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; Calcium Deposits/Calcification

  MAUDE report 22770896 ↗
• InjuryAug 8, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 12 YEARS AND 5 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. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22748718 ↗

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