MOSAIC® 305C227 (UDI 00643169594715)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00643169594715), received between Dec 6, 2017 and Apr 9, 2026 — classified as 1 death, 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 PACEMAKER 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 24827794 ↗
• InjuryFeb 12, 2026Inadequacy of Device Shape and/or Size; Device Stenosis

  IT WAS REPORTED THAT 5 YEARS AND 3 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE PULMONARY POSITION, A PULMONARY TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS STENOSIS DUE OUTGROWTH OFTHE ORIGINAL VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Pulmonary Valve Stenosis

  MAUDE report 24327152 ↗
• InjuryOct 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEARS AND 11 MONTHS POST IMPLANT OF THIS 27MM AORTC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTC 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 23367707 ↗
• InjuryJun 9, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS MOSAIC AORTIC 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 22165281 ↗
• InjuryMar 4, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 21521227 ↗
• InjuryDec 4, 2024Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT EXPERIENCED SEVERE CENTRAL AORTIC INSUFFICIENCY. THE PATIENT HAD AN EXISTING AORTIC TISSUE VALVE, DESCRIBED AS A MOSAIC AORTIC VALVE, WHICH WAS IMPLANTED ON (B)(6) 2017. IT WAS NOTED THAT A NEW TRANSCATHETER VALVE WAS IMPLANTED IN THE AORTIC POSITION ON (B)(6) 2024, AND THE OLD VALVE WAS INACTIVATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20842150 ↗
• InjuryOct 3, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 4 DAYS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS 3RD DEGREE ATRIOVENTRICULAR BLOCK OR COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 20362273 ↗
• InjurySep 26, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 10 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20311176 ↗
• InjuryJul 5, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 4 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS (AS). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY 25 DAYS LATER, THE PATIENT HAD AN AORTIC VALVE-IN-VALVE REPLACEMENT WITH A TRANSCATHETER VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 19680848 ↗
• InjuryApr 16, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 9 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC INSUFFICIENCY (AI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19116272 ↗
• InjuryApr 5, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE 4 YEARS AND 1 MONTH POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 19048790 ↗
• InjuryMar 27, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR REPLACEMENT WAS RECURRENT ENDOCARDITIS WITH LARGE FISTULAS BETWEEN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) IN BOTH THE RIGHT AND LEFT ATRIUMS. IT WAS REPORTED THAT AN AORTIC ROOT FISTULA WAS PRESENT. IT WAS STATED THAT THERE WAS SIGNIFICANT FLOW NOTED IN THE FISTULA BETWEEN THE LVOT AND THE RIGHT ATRIUM AND IN THE FISTULA AT THE BASE OF THE AORTO-MITRAL CURTAIN WITH A PERFORATION THROUGH THE MITRAL VALVE. IT WAS ALSO REPORTED THAT VEGETATIONS HAD ERODED THE FIBROUS STRUCTURE AT THE POINT OF THE AORTIC ROOT AND MITRAL VALVE ANTERIOR LEAFLET. IT WAS MENTIONED THAT NO SIGNIFICANT AORTIC REGURGITATION WAS PRESENT. IT WAS STATED THAT MICRO CULTURES WERE PERFORMED ON THE EXPLANTED VALVE AND ATRIAL MASS AND THE PRESENCE OF METHICILLIN- RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) BACTERIA WAS REVEALED.

  Patient problems: Endocarditis; Fistula; Insufficient Information; Mitral Perforation

  MAUDE report 16617361 ↗
• InjurySep 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 2 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM AORTIC BIOPROSTHETIC VALVE DUE TO INFECTION. THE VALVE WAS SENT FOR CULTURE AND THE RESULTS WERE POSITIVE FOR ASPERGILLUS. THE PATIENT EXPERIENCED SHORTNESS OF BREATH/TIREDNESS AS A RESULT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Dyspnea; Unspecified Infection

  MAUDE report 7880390 ↗
• InjuryAug 2, 2018Perivalvular Leak; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH 29MM VALVE OF THE SAME MODEL.  THE PHYSICIAN REPORTED THE INITIAL VALVE WAS TOO SMALL AND CAUSED PARAVALVULAR LEAK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Code Available; No Information

  MAUDE report 7744916 ↗
• DeathApr 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. IT WAS NOTED IN THE OPERATIVE REPORT THAT PRIOR TO THE PROCEDURE, TWO DIFFERENT SURGEONS CATEGORIZED THE PATIENT AS HIGH RISK FOR DEATH IN AN OPEN HEART PROCEDURE. THERE WAS NO EVIDENCE TO SUGGEST THAT THE VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Death

  MAUDE report 7432223 ↗
• InjuryDec 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 27 MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 23 MM VALVE OF THE SAME MODEL. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7088070 ↗

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