MOSAIC® 310C27 (UDI 00613994689207)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00613994689207), received between Sep 22, 2017 and Aug 12, 2025 — classified as 13 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT THAT 13 YEARS AND 6 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH ANOTHER MANUFACTUERERS PRODUCT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; High Blood Pressure/ Hypertension; Insufficient Information; Mitral Valve Stenosis

  MAUDE report 22786888 ↗
• InjuryNov 18, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 5 MONTHS POST IMPLANT OF THIS 27MM MITRAL 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: Insufficient Information

  MAUDE report 20713707 ↗
• MalfunctionMay 20, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 7 MONTHS POST IMPLANT OF THIS MITRAL 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: Insufficient Information

  MAUDE report 19351099 ↗
• InjuryApr 18, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 9 MONTHS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE MITRAL REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS MITRAL STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 8 DAYS LATER, A TRANSCATHETER VALVE-IN-VALVE MITRAL REPLACEMENT OCCURRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 19137626 ↗
• InjuryMar 21, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 7 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS MITRAL STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 18948152 ↗
• InjuryNov 7, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 3 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A VALVE OF THE SAME MAKE AND MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15744217 ↗
• InjuryJan 10, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A MITRAL BIOPROSTHETIC 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 13204107 ↗
• InjuryDec 21, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC MITRAL MECHANICAL VALVE. THE REASON FOR THE REPLACEMENT WAS REPORTED AS STENOSIS AND SEVERE MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 13056252 ↗
• InjuryAug 17, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS 27MM MITRAL 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 12333143 ↗
• InjuryNov 17, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 10 MONTHS POST IMPLANT OF THIS 27MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 31MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 10856914 ↗
• InjuryOct 15, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT FOUR DAYS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE INDICATION FOR PACEMAKER IMPLANT IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7966501 ↗
• InjuryJan 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27 MM BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 29 MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7183223 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS 3 MONTHS POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED FOR UNKNOWN REASONS. THE VALVE WAS REPLACED WITH ANOTHER BIOPROSTHETIC VALVE OF THE SAME SIZE AND MODEL. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6977505 ↗
• InjurySep 22, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 71 MONTHS POST IMPLANT OF THIS 23 MM BIOPROSTHETIC VALVE, THE VALVE WAS REPLACED WITH A 27 MM VALVE. IT IS UNKNOWN WHY THE VALVE WAS REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Thrombosis

  MAUDE report 6888529 ↗

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