MOSAIC® 310C29 (UDI 00643169594852)Recalls & reported problems

Summary

The FDA's MAUDE database contains 133 adverse event reports that list this exact device (DI 00643169594852), received between Nov 20, 2017 and Sep 25, 2026 — classified as 13 deaths, 110 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (68 reports).

1 FDA recall record name this device's identifier.

2 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 21, 2019Terminated

   Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

   Z-1880-2019 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 133 reports, in the reporter's own words as published by the FDA.

• InjurySep 25, 2026Insufficient Device Problem Information

  Medtronic received information that 7 years and 6 months post implant of this 29mm mitral bioprosthetic valve, it was explanted and replaced with a new 29mm mitral bioprosthetic valve of a different model. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50896357 ↗
• InjurySep 25, 2026Patient Device Interaction Problem

  Medtronic received information that 7 months post implant of this 29mm mitral bioprosthetic valve, a defibrillator was implanted. The reason for the defibrillator was reported as low ejection fraction (EF). No additional adverse patient effects were reported.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 50894809 ↗
• DeathAug 26, 2026Insufficient Device Problem Information

  It was reported that 2 days post implant 29mm mitral bioprosthetic valve and 27mm mitral bioprosthetic valve, the patient died. It was noted that during the mitral valve replacement procedure on (b)(6) 2026, the mitral valve which was explanted during the procedure could not be confirmed. The cause of death was not received. Therefore, relatedness of the death to the valve could not be excluded. It is unknown whether an autopsy was performed.

  Patient problems: Insufficient Information

  MAUDE report 50454462 ↗
• InjuryJun 5, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 6 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: Heart Block

  MAUDE report 25407565 ↗
• InjuryApr 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 7 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE AND 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PA CEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK AND ATRIAL ARRYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF) AND ATRIAL FLUTTER (A-FL)). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia

  MAUDE report 24827795 ↗
• InjuryMar 10, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 5 YEARS AND 1 MONTH POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB) AND ATRIAL ARRHYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF), AND ATRIAL FLUTTER (A-FL). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia

  MAUDE report 24562469 ↗
• InjuryFeb 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 9 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIOVENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24400265 ↗
• InjuryFeb 12, 2026Adverse Event Without Identified Device or Use Problem; Intravalvular regurgitation

  IT WAS REPORTED THAT 2 YEARS AND 8 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A NEW 29MM MITRAL BIOPROSTHETIC VALVE IN THE TRICUSPID POSITION OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 24321359 ↗
• InjuryJan 27, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT APPROXIMATELY 16 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ASYSTOLE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Asystole

  MAUDE report 24187169 ↗
• InjuryJan 22, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24143551 ↗
• InjuryJan 20, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, ON THE SAME DAY A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 24114268 ↗
• InjuryDec 16, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 DAYS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 23814894 ↗
• InjuryDec 15, 2025Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Intravalvular regurgitation; Adverse Event Without Identified Device or Use Problem; Material Split, Cut or Torn; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THE REASON FOR THE REPLACEMENT AS SEVERE MITRAL REGURGITATION (MR) DUE TO TORN MITRAL LEAFLETS. IT WAS ALSO REPORTED THAT THE PATIENT SUFFERED FROM SHORTNESS OF BREATH (SOB) AND DYSPNEA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23801113 ↗
• MalfunctionDec 1, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE CINCH SUTURE HAD BROKE DURING HANDLE TURNING AND CINCHING THE DEVICE. IT WAS FURTHER NOTED THAT A NEW 29MM VALVE WAS USED AND ULTIMATELY IMPLANTED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23685787 ↗
• InjuryNov 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, A PERMANENT BI-VENTRICULAR PACEMAKER WAS IMPLANTED ON THE SAME DAY. THE REASON FOR PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 23665260 ↗
• MalfunctionNov 24, 2025Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Break; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NEW 29MM MITRA L 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; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23639578 ↗
• InjuryOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT 1 YEAR AND 2 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL 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 23310360 ↗
• MalfunctionSep 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT THE SAME DAY POST IMPLANT OF THIS MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PHYSICIAN DID NOT RINSE THE VALVE PRIOR TO IMPLANT PER THE INSTRUCTIONS FOR USE (IFU). NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 23090002 ↗
• InjuryJul 31, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM MOSAIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM MOSAIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22675438 ↗
• InjuryJul 9, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A BIVENTRICULAR DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR IMPLANT WAS REPORTED AS CARDIOMYOPATHY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Cardiomyopathy

  MAUDE report 22455379 ↗
• InjuryJul 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 31MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK AND ATRIAL ARRHYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AF), AND ATRIAL FLUTTER). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Atrial Flutter; Heart Block; Tachycardia

  MAUDE report 22455369 ↗
• MalfunctionMay 15, 2025Break; Break

  IT WAS REPORTED THAT ONE OF THE SUTURES IN THE CINCH MECHANISM OF A 29MM MOSAIC MITRAL VALVE SNAPPED. IT WAS STATED THAT WHEN THE VALVE WITH THE HANDLE SCREWED IN PLACE WAS PASSSED TO THE SURGEON BY THE SCRUB NURSE, THE SURGEON TRIED TO CINCH THE DEVICE, BUT NOTICED THE SUTURE MATERIAL WAS SNAPPED AND THEREFORE, THE VALVE COULD NOT CINCH. A 27MM MOSAIC MITRAL VALVE WAS IMPLANTED INSTEAD AS IT WAS THE CLOSEST AVAILABLE SIZE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026869 ↗
• InjuryMay 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 29MM 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 21969840 ↗
• InjuryApr 1, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF A 29MM MOSAIC MITRAL VALVE AND A 27MM FREESTYLE AORTIC VALVE, THEY WERE EXPLANTED AND REPLACED WITH A 27MM MOSAIC MITRAL VALVE AND A FREESTYLE AORTIC 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; Unspecified Infection

  MAUDE report 21738134 ↗
• InjuryMar 19, 2025Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM MOSAIC MITRAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 31MM MOSAIC MITRAL VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis; Insufficient Information; Mitral Valve Stenosis

  MAUDE report 21643598 ↗

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-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