MOSAIC ULTRA® 305U219 (UDI 00613994760661)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00613994760661), received between Feb 15, 2017 and Aug 17, 2026 — classified as 1 death, 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Insufficient Device Problem Information

  It was reported that an unknown duration 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 not reported. No intervention or adverse patient effects were reported.

  Patient problems: Insufficient Information

  MAUDE report 50271459 ↗
• InjuryAug 26, 2025Patient Device Interaction Problem; Device Stenosis; Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 12 YEARS AND 2 MONTHS POST IMPLANT OF THIS 19MM MOSAIC AORTIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS (AS) AND THROMBUS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Thrombosis/Thrombus

  MAUDE report 22893055 ↗
• MalfunctionMar 10, 2025Calcified; Device Stenosis; Calcified; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 13 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS. IT WAS ALSO REPORTED ON EVALUATION THAT CALCIUM COULD BE SEEN IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE LEFT CORONARY CUSP, IN THE SINTOTUBULAR JUNCTION, THE PROXIMAL LEFT CORONARY ARTERY, THE RIGHT CORONARY ARTERY AND THE RIGHT AND LEFT FEMORAL ARTERIES. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 21562496 ↗
• InjuryAug 30, 2023Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 11 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS MILD TO MODERATE AORTIC INSUFFICIENCY, A GRADIENT INCREASE AND AORTIC STENOSIS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, APPROXIMATELY ONE MONTH LATER, THE VALVE WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 17649066 ↗
• InjuryMar 28, 2023Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 5 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, APPROXIMATELY 3 WEEK LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS WITH A MEAN GRADIENT OF 38MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16626180 ↗
• InjuryNov 11, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 9 YEARS AND 11 MONTHS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Insufficient Information

  MAUDE report 12798909 ↗
• InjuryDec 21, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 10 YEARS AND 1 MONTH 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. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 11050564 ↗
• InjuryJun 16, 2020Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS POST IMPLANT OF THIS 19MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS AORTIC STENOSIS AND INCREASED GRADIENTS THAT LEAD TO SHORTNESS OF BREATH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Dyspnea

  MAUDE report 10158469 ↗
• InjuryFeb 11, 2020Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 7 YEARS AND 2 MONTHS POST IMPLANT OF THIS 19MM BIOPROSTHETIC AORTIC VALVE, IT WAS REPLACED VALVE-IN-VALVE WITH A 26MM TRANSCATHETER VALVE. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Insufficiency; No Information

  MAUDE report 9694029 ↗
• InjuryOct 23, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT SIX YEARS AND SEVEN MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS AND PATIENT PROSTHESIS MISMATCH. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 7998055 ↗
• InjuryMay 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 7493119 ↗
• DeathFeb 15, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  MEDTRONIC RECEIVED INFORMATION FROM THIS PATIENT'S DAUGHTER, THAT THREE YEARS, SEVEN MONTHS POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT WAS HAVING TROUBLE BREATHING AND WAS REFERRED TO HAVE HER HEART VALVE REPLACED DUE TO THE VALVE LEAKING. DURING THE SURGERY, THE SURGEON NOTED THAT IT LOOKED LIKE THERE WAS AN INFECTION ON THE VALVE AND "BUILDUP OF CALCIFICATION AND PLAQUE." THE PATIENT NEVER RECOVERED FROM THE SURGERY AND PASSED AWAY THE FOLLOWING DAY. NO CAUSE OF DEATH OR DEVICE INVOLVEMENT WAS REPORTED.

  Patient problems: Calcium Deposits/Calcification; Death; Vessel Or Plaque, Device Embedded In

  MAUDE report 6332274 ↗

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