MOSAIC ULTRA® 305U219 (UDI 00643169594937)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169594937), received between Jan 29, 2019 and Jun 26, 2026 — classified as 1 death, 9 injuries.

The most frequently reported specific device problem is “Intravalvular regurgitation” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25633243 ↗
• InjurySep 17, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT 6 YEARS AND 6 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS SEVERE AORTIC CENTRAL REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23072248 ↗
• InjuryJul 8, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 6 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 REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22435340 ↗
• InjuryDec 27, 2024Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation; Patient Device Interaction Problem; Thickening of Material; Intravalvular regurgitation

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THAT THE PATIENTS PREVIOUS SURGERY MAY HAVE CONTRIBUTED TO THE REPLACEMENT OF THE AORTIC VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Corneal Pannus; Thrombosis/Thrombus

  MAUDE report 21025154 ↗
• InjuryDec 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN EXPLANT OF AN OLD AORTIC TISSUE VALVE IMPLANTED IN THE PULMONARY POSITION  WAS PERFORMED AND IT WAS REPLACED WITH A NEW TISSUE 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 20843866 ↗
• DeathOct 28, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ON THE SAME DAY AS THE IMPLANT DATE OF THIS  19MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE VALVES COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED

  Patient problems: Insufficient Information

  MAUDE report 20545361 ↗
• InjuryNov 3, 2023Gradient Increase; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 8 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS STENOSIS, AND MILD REGURGITATION WITH A GRADIENT INCREASE. NOADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 18066524 ↗
• InjuryDec 1, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 1 MONTH POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE IMPLANTED IN THE TRICUSPID POSITION IN THIS (B)(6) YEAR OLD PEDIATRIC PATIENT, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12908980 ↗
• InjuryOct 19, 2019Gradient Increase; Use of Device Problem; Gradient Increase; Use of Device Problem

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY TWO YEARS POST IMPLANT OF THIS BIOPROSTHETIC AORTIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A NON-MEDTRONIC VALVE. IT WAS REPORTED THAT THE PRODUCT WAS REPLACED DUE TO A BLOOD CLOT RESULTING IN HIGH GRADIENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Thrombus

  MAUDE report 9211789 ↗
• InjuryJan 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 15 DAYS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED FOR 3RD DEGREE ATRIO-VENTRICULAR (AV) BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Complete Heart Block

  MAUDE report 8285521 ↗

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