MOSAIC® 305C229 (UDI 00643169594722)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169594722), received between Oct 27, 2017 and Dec 17, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 18, 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.

• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 1 DAY POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC 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 23826034 ↗
• InjuryMay 22, 2025Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR INTERVENTION AS SEVERE REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 22073116 ↗
• InjuryMay 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 29MM AORTIC BIOPROSTHETIC VALVE, ON THE SAME DAY THE PATIENT EXPERIENCED UNSPECIFIED HEART RHYTHM CHANGES, THE FOLLOWING DAY THE PATIENT EXPERIENCED PAINFUL BREATHING WITH DYSPNEA AT REST, AN ELECTROCARDIOGRAM (EKG) WAS PERFORMED: SINUS RHYTHM WITH ATRIOVENTRICULAR (AV) DISSOCIATION, AND WIDE QRS RHYTHM WITH OCCASIONAL PREMATURE VENTRICULAR COMPLEXES (PVCS) WERE NOTED. AT THE TIME THE PATIENT "DENIES PAIN, BUT WITH TRANSFER PAIN INCREASED FROM 0-10 ... PATIENT EXPERIENCED INCREASED PAIN WITH ACTIVITY AND DEMONSTRATES SHORT SHALLOW BREATHING DUE TO PAIN... PATIENT IS REFUSING NARCOTIC PAIN MEDS." MEDICATIONS WERE GIVEN, NO SURGICAL INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 19297929 ↗
• InjuryJan 22, 2020Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS AND 12 DAYS POST IMPLANT OF THIS 29MM BIOPROSTHETIC AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A BIOPROSTHETIC VALVE OF THE SAME SIZE AND MODEL DUE TO PARAVALVULAR LEAK (PVL). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficiency, Valvular

  MAUDE report 9616519 ↗
• InjuryFeb 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7280608 ↗
• InjuryOct 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT PRESENTED WITH AN INTRATHORACIC BLEED WHICH REQUIRED THE PATIENT TO GO BACK INTO THE OPERATING ROOM FOR SURGICAL EXPLORATION. EXPLORATION OF THE SURGICAL SITE NOTED THAT THE SOURCE OF THE BLEED COULD NOT BE DETERMINED. THE PATIENT RECEIVED 3 UNITS OF PACKED RED BLOOD CELLS, 3 UNITS OF PLATELETS AND 2 UNITS OF FRESH FROZEN PLASMA. MEDICATION WAS GIVEN TO THE PATIENT AND THE ISSUE WAS RESOLVED THE FOLLOWING DAY. THE DEVICE REMAINS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Blood Loss; Hemolytic Anemia; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 6984451 ↗

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