MOSAIC® 305C225 (UDI 00643169001701)Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00643169001701), received between Dec 2, 2016 and Sep 25, 2026 — classified as 1 death, 62 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (32 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Insufficient Device Problem Information

  Medtronic received information that 12 years and 2 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 50895015 ↗
• InjurySep 18, 2026Intravalvular regurgitation

  It was reported that approximately 12 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 aortic insufficiency (AI). It was reported that an intervention was required. No additional adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50817133 ↗
• InjurySep 11, 2026Intravalvular regurgitation

  It was reported that 12 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 reported as severe aortic central regurgitation and a velocity of 4.4m/s. It was reported that an intervention was required and the patient was hospitalized. Subsequently on the same day 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 50734584 ↗
• MalfunctionApr 11, 2026Calcified; Gradient Increase

  IT WAS REPORTED THAT 10 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. EVIDENCE OF CALCIFICATION SEEN UNDER RIGHT CORONARY CUSP (RCC), LEFT CORONARY CUSP (LCC), AND NON-CORONARY CUSP (NCC) IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) AND IN THE SINO-TUBULAR JUNCTION (STJ) AND ASCENDING AORTA. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24851384 ↗
• InjuryMar 11, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24574687 ↗
• InjuryFeb 20, 2026Calcified; Perivalvular Leak; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR EVALUATION WAS AORTIC STENOSIS, MILD PARA-VALVULAR LEAK AND MODERATE INTRA-VALVULAR LEAK. SUBSEQUENTLY ON (B)(6) 2026 THE PATIENT SUCCESSFULLY HAD AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24400027 ↗
• InjuryFeb 4, 2026Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR THE EVALUATION WAS SEVERE REGURGITATION. SUBSEQUENTLY ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD AN 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24256772 ↗
• InjuryJan 26, 2026Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 2 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. SUBSEQUENTLY, THE SAME DAY, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS, A MEAN GRADIENT OF 38MMHG, MILD AORTIC INSUFFICIENCY AND A MOBILE STRUCTURE ON THE VALVE LEAFLETS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24179699 ↗
• InjuryDec 18, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED ON MARCH 16, 2026, THE PATIENT SUCCESSFULLY HAD A 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23837237 ↗
• InjuryDec 10, 2025Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 12 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 AORTIC CENTRAL REGURGITATION AND AORTIC STENOSIS. SUBSEQUENTLY ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD A 26MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23766862 ↗
• InjuryNov 18, 2025Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM MOSAIC AORTIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS MODERATE PARAVALVULAR LEAK (PVL). EVIDENCE OF CALCIFICATION IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE LEFT CORONARY CUSP (LCC), RIGHT CORONARY CUSP (RCC) AND NON-CORONARY CUSP (NCC). CALCIFICATION ALSO IN SINOTUBULAR JUNCTION (STJ). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23581577 ↗
• InjuryOct 28, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 4 MONTHS POST IMPLANT OF THIS 25MM MOSAIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23400815 ↗
• InjurySep 11, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 4 DAYS 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 23027405 ↗
• InjurySep 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 11 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: Insufficient Information

  MAUDE report 22977154 ↗
• InjuryAug 18, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, 16 DAYS LATER, ANOTHER MANUFACTURERS TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Chest Pain; Dizziness; Syncope/Fainting

  MAUDE report 22828910 ↗
• InjuryJun 25, 2025Degraded; Insufficient Device Problem Information; Degraded; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVA LUATED 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 22330556 ↗
• InjuryJun 6, 2025Intravalvular regurgitation; Intravalvular regurgitation

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

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22159947 ↗
• InjuryApr 28, 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 AN MDT MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21917196 ↗
• InjuryMar 4, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT THERE WAS CENTRAL REGURGITATION OF THE AORTIC VALVE, SPECIFICALLY A 23MM MOSAIC BIOPROSTHETIC VALVE, WITH MODERATE SEVERITY. THE 23MM MOSAIC BIOPROSTHETIC VALVE WAS IMPLANTED ON (B)(6) 2013. ON (B)(6) 2025, A TRANSCATHETER VALVE-IN-VALVE PROCEDURE WAS PERFORMED TO REPLACE THE 23MM MOSAIC BIOPROSTHETIC VALVE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21518560 ↗
• MalfunctionJan 8, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 9 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. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21103762 ↗
• InjurySep 27, 2024Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, A CARDIAC CATHETERIZATION PERFORMED SHOWED THE PRESENCE OF MILD PULMONIC VALVE STENOSIS, A PEAK GRADIENT OF 21 MMHG AND A MEAN GRADIENT OF 16MMHG AND SEVERE PULMONARY REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20320270 ↗
• MalfunctionSep 11, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 11 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 STENOSIS (AS). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 20189550 ↗
• InjurySep 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 7 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, AN IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR WAS REPORTED AS PRIOR SUDDEN CARDIAC ARREST OR VENTRICULAR FIBRILLATION AND 3RD DEGREE ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiac Arrest; Heart Block; Ventricular Fibrillation

  MAUDE report 20124350 ↗
• InjurySep 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, A REPLACEMENT PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE REPLACEMENT PERMANENT PACEMAKER WAS REPORTED AS 2ND DEGREE ATRIOVENTRICULAR BLOCK OR MOBITZ II BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 20124258 ↗
• InjuryAug 6, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 11 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 REGURGITATION (AR) OF AN UNKNOWN SEVERITY. INTERVENTION IS SCHEDULED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19916325 ↗

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