MOSAIC® 310C29 (UDI 00643169001619)Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00643169001619), received between Jan 3, 2017 and Sep 30, 2026 — classified as 2 deaths, 73 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (43 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient Device Interaction Problem

  It was reported that 11 years and 7 months post implant of this 29mm mitral bioprosthetic valve, the patient was admitted to the hospital for heart failure. It was reported during the admission the patient was told that one of her mitral valve leaflets was "flapping". It was reported that the patient had follow-up echocardiogram which demonstrated a drop in ejection fraction (EF) to 50-54% and an extended left ventricle (LV). No intervention or adverse patient effects were reported.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50943694 ↗
• InjurySep 22, 2026Device Stenosis

  It was reported that approximately 12 years and 1 month post implant of this 29mm mitral bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement or a surgical valve replacement. The reason for evaluation was reported as mitral stenosis. It was reported that an intervention was required. No additional adverse patient effects were reported.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 50852532 ↗
• InjurySep 17, 2026Insufficient Device Problem Information

  It was reported that during the implant of this 29mm mitral bioprosthetic valve, it was explanted and replaced with an unknown devic e. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50798767 ↗
• InjurySep 14, 2026Insufficient Device Problem Information

  Medtronic received information from a patient that approximately 10 years post-implant of this 29mm Mosaic mitral bioprosthetic valve, it was explanted and replaced with an unknown valve. It was reported by the patient that the valve was no longer active and had expired. The patient also stated that they no longer had the device. The reason for the replacement was not reported. No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50750919 ↗
• InjurySep 10, 2026Insufficient Device Problem Information

  It was reported that 10 years and 1 month post implant of this 29mm mitral bioprosthetic valve, the patient was being evaluated for a replacement. The reason for evaluation was not reported. It was noted that the patient was scheduled with a reintervention and was receiving a Non-Medtronic valve on (b)(6) 2026.  No additional adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50714177 ↗
• InjuryMay 19, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING THE IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION, IT WAS EXPLANTED AND REPLACED WITH A 27MM MITRAL BIOPROSTHETIC VALVE IMPLANTED IN THE SAME POSITION OR VICE-VERSA. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25212785 ↗
• InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 11 YEARS AND 11 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A NEW 29MM 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 24871233 ↗
• InjuryDec 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT 8 YEAR AND 11 MONTHS 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 23877804 ↗
• InjuryNov 28, 2025Perivalvular Leak; Intravalvular regurgitation; Perivalvular Leak; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON THE SAME DAY, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. IT WAS ALSO REPORTED THAT THE LEVEL OF THE PARAVALVULAR LEAK (PVL) WAS "SEVERE". NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Heart Failure/Congestive Heart Failure

  MAUDE report 23671190 ↗
• InjurySep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS 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 22992507 ↗
• InjuryAug 11, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, 1 MONTH AND 11 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22773351 ↗
• InjuryJun 13, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A DEFIBRILLATOR WAS IMPLANTED. THE REASON FOR THE DEFIBRILLATOR WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 22205120 ↗
• InjuryJun 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A 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 22186960 ↗
• InjuryJun 10, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION 8 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR ENDOCARDITIS. THE ORGANISM CULTURED WAS STAPHYLOCOCCUS AUREUS. THE ONSET OF INFECTION IS UNKNOWN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Endocarditis

  MAUDE report 22177169 ↗
• InjuryMay 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 6 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, 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 22012328 ↗
• InjuryMay 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 5 MONTHS POST IMPLANT OF THIS MOSAIC MITRAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22009236 ↗
• InjuryMay 13, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 10 DAYS POST IMPLANT OF THIS MOSAIC MITRAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22008973 ↗
• InjuryMay 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 6 MONTHS POST IMPLANT OF THIS 19MM MITRAL BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 28MM MITRAL ANNULOPLASTY RING. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21987297 ↗
• InjuryMar 24, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS MOSAIC MITRAL 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 21677258 ↗
• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING AND 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR CHRONIC CEREBRAL ATROPHY AND HAD EXPERIENCED MULTIPLE FALLS, WEAKNESS AND SLURRED SPEECH. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21061090 ↗
• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 9 MONTHS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING AND 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR CHEST PAIN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain

  MAUDE report 21054313 ↗
• InjuryJan 2, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS POST IMPLANT OF THIS 32MM TRICUSPID ANNULOPLASTY RING AND 29MM MITRAL BIOPROSTHETIC VALVE, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR 2 DAYS WITH CHEST PAIN. NO INTERVENTION OR ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Chest Pain

  MAUDE report 21054215 ↗
• InjuryNov 11, 2024Device Stenosis; Intravalvular regurgitation; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 9 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A DIFFERENT MANUFACTURERS MITRAL TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MITRAL STENOSIS AND MITRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20653702 ↗
• InjuryOct 17, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT  OF THIS 29MM MITRAL BIOPROSTHETIC VALVE AND 32MM TRICUSPID ANNULOPLASTY RING, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS BRADYCARDIA/TACHYCARDIA SYNDROME. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 20471938 ↗
• InjuryAug 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 3 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS ATRIAL ARRHYTHMIAS (ATRIAL TACHYCARDIA (AT), ATRIAL FIBRILLATION (AFIB), ATRIAL FLUTTER). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Atrial Fibrillation; Non specific EKG/ECG Changes; Tachycardia

  MAUDE report 20025114 ↗

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