MOSAIC® 305C219 (UDI 00643169001794)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169001794), received between Oct 11, 2019 and Mar 2, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 3 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 18 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: Insufficient Information

  MAUDE report 16467283 ↗
• InjuryJul 6, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 5 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 14925204 ↗
• InjuryJan 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 3 MONTHS POST IMPLANT OF THIS 19MM BIOPROSTHETIC AORTIC VALVE, A NON-MEDTRONIC 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 11246193 ↗
• InjuryApr 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 2 YEARS AND 11 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 21MM AORTIC ROOT BIOPROSTHESIS. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9981982 ↗
• InjuryJan 9, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 9 MONTHS POST IMPLANT OF THIS 19MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9570235 ↗
• InjuryOct 11, 2019Off-Label Use; Insufficient Device Problem Information; Off-Label Use; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 2 MONTHS POST IMPLANT OF THIS 19MM BIOPROSTHETIC VALVE IN THE PULMONARY POSITION, A VALVE-IN-VALVE PROCEDURE WAS PERFORMED DUE TO STENOSIS AND MODERATE TO SEVERE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Regurgitation; Pulmonary Valve Stenosis

  MAUDE report 9179958 ↗

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