MOSAIC® 305C229 (UDI 00643169001954)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169001954), received between May 12, 2017 and Mar 19, 2026 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (7 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 DAYS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24637687 ↗
• MalfunctionNov 6, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 10 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 (AS) AND MILD AORTIC INSUFFICIENCY (AI). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20622136 ↗
• InjuryAug 29, 2023Gradient Increase; Perivalvular Leak; Material Separation; Insufficient Device Problem Information; Gradient Increase; Perivalvular Leak; Material Separation; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM VALVE OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Abscess; Aortic Valve Stenosis; Endocarditis; Insufficient Information; Unspecified Infection; Valvular Insufficiency/ Regurgitation

  MAUDE report 17642390 ↗
• InjuryAug 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE THAT 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. ADDITIONAL INFORMATION WAS RECEIVED WHICH STATED THAT IN THE SAME MONTH, A 26MM NON-MEDTRONIC TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 17621961 ↗
• InjuryMar 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 2 MONTHS POST IMPLANT OF THIS 29MM 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, 7 DAYS LATER, IT WAS EXPLANTED AND REPLACED WITH A 25MM 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 16503148 ↗
• InjuryOct 12, 2021Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 5 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS WITH AN AORTIC GRADIENT OF 40MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 12615882 ↗
• InjuryJan 14, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 11 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE. 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 11175515 ↗
• InjuryApr 6, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9928232 ↗
• InjuryApr 30, 2019Gradient Increase; Incomplete Coaptation; Gradient Increase; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS 9 MONTHS POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH SYMPTOMS OF A STROKE. AN ECHOCARDIOGRAM WAS PERFORMED WHICH INDICATED A FLAILED LEAFLET WITH "INCIPIENT" AORTIC INSUFFICIENCY AND A MEAN GRADIENT OF 23MMHG. THE VALVE SUCCESSFULLY WAS REPLACED VALVE-IN-VALVE WITH A TRANSCATHETER VALVE, WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Aortic Insufficiency; Stroke/CVA

  MAUDE report 8565216 ↗
• InjuryNov 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THREE YEARS AND ONE MONTH POST IMPLANT OF THIS BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED DUE TO LEAFLET DEHISCENCE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cusp Tear

  MAUDE report 8111510 ↗
• InjuryMay 12, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED. NO FAILURE MECHANISM WAS PROVIDED. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6565012 ↗

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