MOSAIC ULTRA® 305U27Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 00885074253268), received between Jul 7, 2017 and Jun 17, 2026 — classified as 1 death, 120 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (92 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 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• DeathJun 17, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT APPROXIMATELY 17 YEARS POST IMPLANT OF THIS 27 MM AORTIC BIOPROSTHETIC VALVE AND 32 MM MITRAL ANNULOPLASTY RING, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. THEREFORE, RELATEDNESS OF THE DEATH TO THE AORTIC BIOPROSTHETIC VALVE AND THE MITRAL ANNULOPLASTY RING COULD NOT BE EXCLUDED. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED.

  Patient problems: Insufficient Information

  MAUDE report 25533296 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT AN UNKNOWN DURATION POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH AN UNKNOWN HOMOGRAFT. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24746103 ↗
• InjuryJan 23, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 14 YEARS AND 8 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 NOT REPORTED. IT WAS REPORTED THAT AN INTERVENTION IS REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24159681 ↗
• InjuryJan 8, 2026Patient Device Interaction Problem

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PHYSICIAN DOES BELIEVE THE HEART VALVE OR IMPLANT PROCEDURE CAUSED OR CONTRIBUTED TO THE COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 24003284 ↗
• InjuryJan 6, 2026Gradient Increase; Device Stenosis

  IT WAS REPORTED THAT 16 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 AORTIC STENOSIS (AS) AND HIGH GRADIENT (HG) OF 61MMHG. SUBSEQUENTLY ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD A 26MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23975427 ↗
• MalfunctionDec 17, 2025Calcified; Gradient Increase; Device Stenosis; Intravalvular regurgitation; Calcified; Gradient Increase; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 17 YEARS 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 MILD CENTRAL AORTIC REGURGITATION, STENOSIS, AORTIC VALVE AREA (AVA) OF 0.8CM^2, CALCIFIED AND DEGENERATED BIOPROSTHETIC VALVE WITH MEAN GRADIENT OF 42MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 23829227 ↗
• InjuryDec 1, 2025Gradient Increase; Device Stenosis; Gradient Increase; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT THE GRADIENT WAS 8MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23680030 ↗
• InjuryJul 17, 2025Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 10 MONTHS POST IMPLANT OF THIS 27MM MOSAIC AORTIC VALVE, THE PATIENT WAS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. EVIDENCE OF ANNULAR CALCIFICATION SEEN UNDER THE RIGHT CORONARY CUSP (RCC). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 2 WEEKS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS A FLAILED LEAFLET AND AORTIC INSUFFICIENCY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification

  MAUDE report 22529182 ↗
• InjuryJun 13, 2025Gradient Increase; Perivalvular Leak; Gradient Increase; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT 15 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVAL UATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS PARAVALVULAR LEAK. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 15 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. IT WAS ALSO REPORTED THAT THE MEAN GRADIENT PRIOR TO REPLACEMENT WAS 22MMHG. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 22206948 ↗
• InjuryMar 12, 2025Calcified; Patient Device Interaction Problem; Device Stenosis; Calcified; Patient Device Interaction Problem; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A MEDTRONIC VALVE 305U27 MOSAIC AORTIC ULTRA 27MM EXPERIENCED HEART FAILURE, VALVE STENOSIS AND VALVE CALCIFICATION. THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT INVOLVING THE REPLACEMENT OF THE MEDTRONIC MOSAIC VALVE. THE TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE IN THE AORTIC POSITION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 21586356 ↗
• InjuryFeb 20, 2025Degraded; Gradient Increase; Patient Device Interaction Problem; Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation; Degraded; Gradient Increase; Patient Device Interaction Problem; Material Split, Cut or Torn; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 11 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 SEVERE AORTIC REGURGITATION, AORTIC STENOSIS, A POSSIBLE TORN NON-CORONARY LEAFLET OR OLD VEGETATION ON THE VALVE AND A MEAN GRADIENT OF 53MMHG WITH A DECREASED EJECTION FRACTION OF 45-50%. SUBSEQUENTLY, 1 MONTH LATER, THE PATIENT WAS HOSPITALIZED DUE TO WORSENING SHORTNESS OF BREATH AND CHRONIC DIASTOLIC HEART FAILURE. MEDICATION WAS ADMINISTERED. A TAVR INTERVENTION WAS SCHEDULED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Cusp Tear; Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 21425131 ↗
• InjuryJan 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 8 YEARS AND 9 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS INCOMPLETE ATRIO-VENTRICULAR BLOCK (AVB). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 21241898 ↗
• InjuryJan 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 10 MONTHS 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 21241791 ↗
• InjuryJan 23, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT IMPLANTED A 27MM MOSAIC AORTIC ULTRA VALVE WAS HOSPITALIZED FOR SEVERE AORTIC REGURGITATION. ONE DAY LATER, THE PATIENT UNDERWENT A SUCCESSFUL VALVE-IN-VALVE PROCEDURE UTILIZING A TRANSCATHETER AORTIC VALVE OF A DIFFERENT MANUFACTURER. NO ISSUES WERE REPORTED DURING OR IMMEDIATELY FOLLOWING THE PROCEDURE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21215004 ↗
• InjuryDec 6, 2024Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Patient Device Interaction Problem; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 17 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 27MM VALVE OF A DIFFERENT MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS AORTIC STENOSIS AND SEVERE AORTIC INSUFFICIENCY. A MEAN GRADIENT OF 30MMHG, PEAK GRADIENT OF 48.3MMHG, MODERATE SIZE LEFT AND RIGHT PLEURAL EFFUSION WERE REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 20872693 ↗
• MalfunctionDec 3, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 11 YEARS AND 6 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 INSUFFICIENCY WITH A PRESSURE HALF TIME OF 283 MILLISECONDS. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20834755 ↗
• InjuryNov 27, 2024Calcified; Insufficient Device Problem Information; Calcified; Insufficient Device Problem Information

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED SUBSEQUENTLY, 26 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 20798113 ↗
• InjuryOct 9, 2024Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation; Gradient Increase; Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT 1 MONTH LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE DUE TO SEVERE AORTIC INSUFFICIENCY. IT WAS STATED THAT STENOSIS AND HIGH GRADIENT WERE NOTED PRIOR TO THE TRANSCATHETER VALVE IMPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 20411134 ↗
• MalfunctionOct 1, 2024Calcified; Device Stenosis; Intravalvular regurgitation; Calcified; Device Stenosis; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 7 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVAL UATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS NOT REPORTED. IT WAS NOTED THAT CALCIFICATION CAN BE SEEN UNDER THE LEFT CORONARY CUSP, IN THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) UNDER THE NON-CORONARY CUSP, IN THE PROXIMAL LEFT CORONARY ARTERY AND POSSIBLE CALCIFIED DISSECTION SEEN IN THE AORTIC ARCH. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Calcium Deposits/Calcification

  MAUDE report 20341905 ↗
• InjurySep 17, 2024Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Material Split, Cut or Torn; Thickening of Material; Intravalvular regurgitation; Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Material Split, Cut or Torn; Thickening of Material; Intravalvular regurgitation

  MEDTRONIC RECEIVED ADDITIONAL INFORMATION WHICH STATED THAT THE REASON FOR THE REPLACEMENT WAS SEVERE CHRONIC AORTIC REGURGITATION (AR). IT WAS STATED THAT DURING EXPLANT OF THE VALVE, IT WAS OBSERVED THAT ONE VALVE LEAFLET WAS MISSING ENTIRELY AND THE OTHER TWO LEAFLETS WERE BADLY DEGENERATED WITH MICROCALCIFIED COMMISSURES, MINOR THROMBUS AND CRACKS. IT WAS NOTED THAT THE PATIENTS NATIVE ANNULUS WAS ALSO CALCIFIED. PANNUS WAS ALSO OBSERVED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Calcium Deposits/Calcification; Insufficient Information

  MAUDE report 20241481 ↗
• InjuryJun 10, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 11 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, 5 DAYS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19498435 ↗
• InjuryMay 7, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT APPROXIMATELY 7 YEARS AND 8 MONTHS POST IMPLANT OF THIS 27MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE FROM A DIFFERENT MANUFACTURER 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 19259030 ↗
• InjuryApr 18, 2024Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 10 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A 26MM TRANSCATHETER VALVE OF ANOTHER MANUFACTURER WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS MODERATE TO SEVERE AORTIC REGURGITATION DUE TO A FLAIL LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 19132494 ↗
• InjuryMar 5, 2024Insufficient Device Problem Information; Intravalvular regurgitation; Insufficient Device Problem Information; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION THAT 14 YEARS AND 6 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 NOT REPORTED. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENTLY, 13 DAYS LATER, A 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 Insufficiency/ Regurgitation; Insufficient Information

  MAUDE report 18838176 ↗
• InjuryMar 5, 2024Intravalvular regurgitation; Intravalvular regurgitation

  MEDTRONIC RECEIVED INFORMATION 15 YEARS AND 3 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE THAT THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS SEVERE AORTIC REGURGITATION (AR). NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18835411 ↗

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