MOSAIC ULTRA® 305U225 (UDI 00613994760609)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00613994760609), received between Jan 8, 2018 and Sep 25, 2026 — classified as 47 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (29 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 50 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Patient Device Interaction Problem

  It was reported that 4 years and 11 months post implant of this 25mm aortic bioprosthetic valve, a permanent pacemaker was implanted. The reason for the permanent pacemaker was reported as incomplete atrioventricular block (AVB). No additional adverse patient effects were reported.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50894693 ↗
• InjuryJun 18, 2026Calcified; Gradient Increase; Intravalvular regurgitation

  IT WAS REPORTED THAT 15 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 INCREASED GRADIENT WITH SEVERE AORTIC REGURGITATION. EVIDENCE OF CALCIFICATION WAS SEEN IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER LEFT CORONARY CUSP (LCC). 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

  MAUDE report 25544911 ↗
• InjuryApr 14, 2026Device Stenosis

  IT WAS REPORTED THAT 14 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 VALVE STENOSIS. SUBSEQUENTLY 1 DAY LATER, 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 24871344 ↗
• InjuryMar 25, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT APPROXIMATELY 13 YEARS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DISCOVERED A "SMALL LEAK". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 24687112 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 12 YEARS 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 24302376 ↗
• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 13 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 23862924 ↗
• InjuryDec 19, 2025Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS AND 6 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A 26MM 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; Insufficient Information

  MAUDE report 23848305 ↗
• InjuryDec 17, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 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 Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 23826403 ↗
• InjuryNov 7, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS AND 7 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. SUBSEQUENTLY ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD AN 26MM AORTIC TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23495928 ↗
• InjuryAug 29, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 1 MONTH 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 INSUFFICIENCY. AN INTERVENTION IS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 8 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22923479 ↗
• InjuryMay 21, 2025Device Stenosis; Device Stenosis

  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 REPORTED AS AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22058938 ↗
• InjuryApr 30, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  IT WAS REPORTED THAT 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; Insufficient Information

  MAUDE report 21933795 ↗
• InjuryApr 22, 2025Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT POST IMPLANT OF THIS 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: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21879964 ↗
• InjuryMar 21, 2025Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT ALSO REPORTED THE REASON FOR EVALUATION AS SEVERE AORTIC INSUFFICIENCY. SUBSEQUENTLY, 22 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Corneal Pannus; Thrombosis/Thrombus

  MAUDE report 21664017 ↗
• InjuryMar 19, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE REASON FOR INTERVENTION WAS MODERATE AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Insufficient Information; Thrombosis/Thrombus

  MAUDE report 21641689 ↗
• InjuryFeb 21, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 13 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 5 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; Insufficient Information

  MAUDE report 21433761 ↗
• MalfunctionJan 29, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT REPORTED SUBSEQUENTLY, 1 MONTH AND 3 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 21263014 ↗
• MalfunctionJan 17, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS (AS), A MEAN GRADIENT OF 26MMHG AND EJECTION FRACTION (EF) OF 26%. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21184664 ↗
• MalfunctionJan 14, 2025Device Stenosis; Device Stenosis

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

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21149264 ↗
• InjuryJan 3, 2025Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Gradient Increase; Insufficient Device Problem Information; Device Stenosis

  IT WAS REPORTED THAT A PATIENT IMPLANTED WITH A 25MM MOSAIC AORTIC VALVE WAS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. SUBSEQUENTLY, 3 WEEKS LATER, A 26MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THERE WERE NO SPECIFIED SYMPTOMS OR ADVERSE OUTCOMES REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21065744 ↗
• InjuryAug 14, 2024Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 13 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS) AND A GRADIENT OF 50MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19983052 ↗
• InjuryJun 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 28MM ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19536092 ↗
• InjuryJun 3, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE OF A DIFFERENT MANUFACTURER. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19455309 ↗
• InjuryMay 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM 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 19321243 ↗
• InjuryMar 25, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 12 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 AORTIC INSUFFICIENCY (AI), SEVERITY UNKNOWN. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 1 MONTH AND 24 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE TO SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18968654 ↗

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