Mosaic Neo™ 310 310MN27Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000990565), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 27MM MOSAIC NEO BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE VALVE WAS CINCHED FOR A DURATION LONGER THAN THE IFU RECOMMENDS. AFTER THE VALVE WAS OPENED THE SURGEON PLACED ANNULAR SUTURES AS STANDARD PROCEDURE. THE PATIENT ANATOMY MADE THIS MORE TIME CONSUMING THAN INITIALLY PLANNED. ONCE THE VALVE WAS CINCHED FOR A DURATION LONGER THAN THE IFU RECOMMENDS, THE FIELD REPRESENTATIVE ASKED THE NURSING STAFF TO OPEN THE BACKUP VALVE TO ENSURE VALVE FUNCTIONED AS INTENDED. THE VALVE IN QUESTION WAS NEVER IMPLANTED, NO ISSUES WERE SEEN ON THE VALVE AND WAS DISCARDED ON TABLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25299416 ↗

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