MOSAIC® 305C19Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00721902694721), received between Dec 11, 2017 and Mar 13, 2024 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMar 13, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 19 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE AORTIC REGURGITATION (AR). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18892781 ↗
• InjuryDec 6, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION APPROXIMATELY 9 YEARS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 19MM TISSUE 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 18277114 ↗
• InjuryAug 9, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 16 YEARS AND 5 MONTHS POST IMPLANT OF THIS 19MM 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 AND AORTIC STENOSIS . NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17492165 ↗
• InjuryDec 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 9 MONTHS POST IMPLANT OF THIS 19MM 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 12 DAYS LATER, 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 15987085 ↗
• InjuryMay 5, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 2 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS COMBINED AORTIC INSUFFICIENCY AND AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 11776235 ↗
• InjuryJul 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 4 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, IT WAS REPLACED VALVE-IN-VALVE WITH A 23MM TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10265515 ↗
• InjuryApr 29, 2020Restricted Flow rate; Restricted Flow rate

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO AORTIC STENOSIS (AS) AND LOW FLOW/LOW GRADIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 10009293 ↗
• InjuryJan 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 2 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS MIXED DISEASE WITH MODERATE AORTIC INSUFFICIENCY AND SEVERE AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 9616690 ↗
• InjuryAug 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 10 MONTHS POST IMPLANT OF THIS 19MM BIOPROSTHETIC AORTIC VALVE, IT WAS REPLACED VALVE-IN-VALVE WITH A 23MM TRANSCATHETER VALVE. THE REASONS FOR REPLACEMENT WERE REPORTED AS AORTIC STENOSIS AND AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis

  MAUDE report 8871614 ↗
• InjuryJun 12, 2019Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 2 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: Aortic Valve Stenosis; Dyspnea; No Information

  MAUDE report 8693277 ↗
• InjuryJan 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; No Information

  MAUDE report 8217987 ↗
• InjuryNov 5, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Information

  MAUDE report 8037205 ↗
• InjuryApr 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 7 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, A TRANSCATHETER BIOPROSTHETIC VALVE WAS IMPLANTED VALVE-IN-VALVE IN THE AORTIC POSITION.  THE REASON FOR THE INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; No Information

  MAUDE report 7389285 ↗
• InjuryMar 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 7 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 21MM VALVE OF A DIFFERENT MODEL.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7342616 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 5 MONTHS POST IMPLANT OF THIS 19 MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH 25 MM VALVE OF THE SAME MODEL.  THE REASON FOR THE EXPLANT WAS NOT REPORTED.  NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; Aortic Valve Stenosis; No Information

  MAUDE report 7104586 ↗

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