MOSAIC ULTRA® 305U227 (UDI 00643169594975)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00643169594975), received between Oct 29, 2018 and Jun 11, 2026 — classified as 1 death, 30 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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 35 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2026Device Stenosis

  IT WAS REPORTED THAT 8 YEARS AND 10 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 STENOSIS. IT WAS REPORTED THAT AN INTERVENTION WAS REQUIRED. SUBSEQUENTLY THE SAME DAY ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 25468549 ↗
• InjuryApr 3, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVIC E. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24781519 ↗
• MalfunctionFeb 9, 2026Gradient Increase; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE AORTIC VALVE MEAN GRADIENT WAS 12MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24289814 ↗
• InjuryJan 22, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED ON JANUARY 23, 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; Aortic Valve Stenosis; Insufficient Information

  MAUDE report 24144675 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem; Device Stenosis

  IT WAS REPORTED THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 23972126 ↗
• InjuryNov 25, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 9 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 REPORTED AS AORTIC REGURGITATION (AR). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23642712 ↗
• InjuryNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 6 YEARS AND 1 MONTH POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO INTERVENTION OR ADDITIONAL PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23508218 ↗
• MalfunctionSep 15, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 5 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 AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23051685 ↗
• MalfunctionSep 15, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 7 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. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23051641 ↗
• InjurySep 3, 2025Device Stenosis; Device Stenosis

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT, 6 WEEKS 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 22955542 ↗
• InjuryAug 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM MOSAIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AVALUS VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22814463 ↗
• InjuryMay 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS MOSAIC AORTIC VALVE, THE PATIENT WAS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE RE PLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. SUBSEQUENTLY, 1 WEEK 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: Insufficient Information

  MAUDE report 22025121 ↗
• InjuryFeb 20, 2025Insufficient Device Problem Information; Device Stenosis; Insufficient Device Problem Information; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR EVALUATION AS AORTIC STENOSIS. SUBSEQUENTLY, 14 DAYS LATER, A TRANS CATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 21420180 ↗
• InjuryJan 27, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 3 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 MODERATE AORTIC STENOSIS AND A GRADIENT OF 29.8MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21242938 ↗
• MalfunctionJan 17, 2025Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 3 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 MODERATE TO SEVERE AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21183065 ↗
• InjuryApr 8, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 4 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, IT WAS EXPLANTED AND REPLACED WITH A 27MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19061837 ↗
• InjuryMar 28, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 25MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. IT WAS STATED THAT THE HEALTHCARE PROFESSIONAL (HCP) HAD CONCERNS ABOUT ONE OF THE VALVE LEAFLETS AND DECIDED NOT TO IMPLANT IT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18993249 ↗
• InjuryMar 14, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 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 SEVERE AORTIC STENOSIS (AS). IT WAS STATED THAT THE PATIENT WAS HOSPITALIZED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 18901412 ↗
• InjuryJan 9, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 18476010 ↗
• InjuryNov 15, 2023Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 5 YEARS AND 6 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 17 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS) AND MODERATE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18145520 ↗
• InjurySep 27, 2023Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR REPLACEMENT WAS CHRONIC BACTERIAL ENDOCARDITIS AND AORTIC VALVE STENOSIS. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH SEVERE AORTIC INSUFFICIENCY AND SEVERE SHORTNESS OF BREATH AT A PRE-OPERATIVE EXAM 12 DAYS PRIOR TO THE REPLACEMENT PROCEDURE. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED THE PRESENCE OF VEGETATION. BLOOD CULTURES WERE PERFORMED ON TWO OCCASIONS PRIOR TO THE REPLACEMENT PROCEDURE AND WERE BOTH NEGATIVE. DURING THE REPLACEMENT PROCEDURE, IT WAS NOTED THAT MOST OF THE DETERIORATION WAS OBSERVED ON THE LEAFLETS SECONDARY TO ENDOCARDITIS AND THAT NO PERIVALVULAR LEAK WAS OBSERVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17825374 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIO-VENTRICULAR BLOCK (COMPLETE HEART BLOCK). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 16263577 ↗
• InjuryOct 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15705068 ↗
• InjurySep 16, 2022Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 4 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A 29MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE TO SEVERE AORTIC INSUFFICIENCY, AORTIC STENOSIS AND A HIGH GRADIENT OF OVER 40MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 15439509 ↗
• InjuryMar 1, 2022Gradient Increase; Thickening of Material; Gradient Increase; Thickening of Material

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 1 MONTH POST IMPLANT OF AN AORTIC BIOPROSTHETIC VALVE, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND IT WAS NOTED THAT THERE WERE INCREASED AORTIC VELOCITY AND GRADIENTS. THE PATIENT WAS ASYMPTOMATIC. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. IT WAS ALSO REPORTED THAT 3 YEARS AND 2 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED WORSENING AORTIC STENOSIS. ULTIMATELY 3 YEARS AND 10 MONTHS POST IMPLANT, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 13639632 ↗

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