MOSAIC® 305C225 (UDI 00643169594760)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169594760), received between Apr 10, 2019 and Jul 27, 2026 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Intravalvular regurgitation

  Medtronic received information that 9 years and 8 months post implant of this 25mm Mosaic aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement or a possible redo surgical aortic valve replacement. The reason for evaluation was reported as moderate aortic regurgitation (AR). No intervention or adverse patient effects were reported.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50020138 ↗
• InjuryMay 28, 2026Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 3 DAYS POST IMPLANT OF THIS 25MM MOSAIC 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 25316818 ↗
• InjuryJan 21, 2026Insufficient Device Problem Information

  ADDITIONAL INFORMATION RECEIVED REPORTED ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A 26MM AORTIC TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24130109 ↗
• InjuryFeb 7, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR AND 3 MONTHS POST IMPLANT OF THIS 25 MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SICK SINUS SYNDROME (SSS), LEFT BUNDLE BRANCH BLOCK (LBBB) AND RIGHT BUNDLE BRANCH BLOCK (RBBB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21334079 ↗
• MalfunctionJan 21, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT UNDERWENT A 5 YEAR FOLLOW-UP ECHOCARDIOGRAM (ECHO) WHICH INDICATED AN INCREASED MEAN GRADIENT OF 28MMHG WITH DECREASED AORTIC VALVE AREA (AVA) OF 1.1 CM2, INDICATING POSSIBLE STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 20 DAYS LATER, A TRANSTHORACIC ECHOCARDIOGRAM (TEE) DEMONSTRATED NO AORTIC STENOSIS OR AORTIC REGURGITATION. THE TEE ALSO DEMONSTRATED AN AVA OF 1.6CM2 WITH A MEAN GRADIENT OF 15MMHG. THE PATIENT HAS SINCE RECOVERED/RESOLVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 21195360 ↗
• InjuryJul 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE AND 34MM TRICUSPID ANNULOPLASTY RING, A REPLACEMENT PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIO-VENTRICULAR BLOCK (AVB), ATRIAL TACHYCARDIA, ATRIAL FLUTTER AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19708744 ↗
• InjuryJul 10, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 5 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE AND 34MM TRICUSPID ANNULOPLASTY RING, A REPLACEMENT PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK (CHB), ATRIAL TACHYCARDIA, ATRIAL FLUTTER AND ATRIAL FIBRILLATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 19708692 ↗
• InjuryJun 12, 2024Calcified; Intravalvular regurgitation; Calcified; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 10 MONTHS POST IMPLANT OF THIS 25MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS VALVE CALCIFICATION WITH AORTIC INSUFFICIENCY (AI) OF AN UNKNOWN SEVERITY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19519618 ↗
• InjuryMar 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS POST IMPLANT OF THIS 25MM BIOPROSTHETIC AORTIC VALVE, IT WAS REPLACED VALVE-IN-VALVE WITH A 26MM TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency

  MAUDE report 9847722 ↗
• InjuryApr 10, 2019Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 YEARS AND 9 MONTHS POST IMPLANT OF THIS BIOPROSTHETIC MITRAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE. THE REASON FOR VALVE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Stenosis

  MAUDE report 8501449 ↗

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