MOSAIC ULTRA® 305U221 (UDI 00643169595002)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00643169595002), received between Jun 6, 2017 and Mar 24, 2026 — classified as 1 death, 16 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (11 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryMar 24, 2026Insufficient Device Problem Information; Device Stenosis; Intravalvular regurgitation

  IT WAS REPORTED THAT 9 YEARS POST IMPLANT OF THIS 21MM 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 SCHEDULED FOR (B)(6) 2026. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

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

  MAUDE report 24674362 ↗
• InjuryJan 12, 2026Gradient Increase; Device Stenosis

  IT WAS REPORTED THAT 8 YEARS AND 6 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS AORTIC STENOSIS AND MEAN GRADIENT OF 48MMHG. SUBSEQUENTLY, ON (B)(6) 2026, THE PATIENT SUCCESSFULLY HAD A 23MM TRANSCATHETER VALVE IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24035366 ↗
• InjurySep 10, 2025Intravalvular regurgitation; Intravalvular regurgitation

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2025, THE PATIENT SUCCESSFULLY HAD A 23MM TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23019152 ↗
• MalfunctionJan 31, 2025Gradient Increase; Gradient Increase

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 3 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE-IN-VALVE REPLACEMENT. THE REASON FOR EVALUATION WAS REPORTED AS INCREASED GRADIENTS OF 40MMHG. NO INTERVENTION OR ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21287378 ↗
• MalfunctionSep 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 6 YEARS AND 3 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.

  Patient problems: Insufficient Information

  MAUDE report 20234730 ↗
• InjuryApr 29, 2024Device Stenosis; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 6 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, IT WAS REPORTED THAT AORTIC STENOSIS (AS) WAS OBSERVED. TWO MONTHS LATER, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 19199889 ↗
• InjuryFeb 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 8 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, 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 16379735 ↗
• InjuryNov 8, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15750554 ↗
• InjuryOct 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 5 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 23MM BIOPROSTHETIC VALVE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15616291 ↗
• InjurySep 24, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 5 MONTHS POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, A 23MM TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AS STENOSIS WITH PEAK VELOCITY OF 4.1 M/S. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15480002 ↗
• InjurySep 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 10 MONTHS POST IMPLANT OF THIS 21 MM AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED AORTIC STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 15400637 ↗
• InjuryApr 11, 2022Gradient Increase; Insufficient Device Problem Information; Gradient Increase; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 4 MONTHS POST IMPLANT OF THIS AORTIC BIOPROSTHETIC VALVE, A TRANSCATHETER VALVE WAS IMPLANTED VALVE-IN-VALVE. THE REASON FOR INTERVENTION WAS REPORTED TO BE DUE TO AN INCREASED GRADIENT OF 60MM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 14074113 ↗
• InjuryAug 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT SEVERAL HOURS POST IMPLANT OF THIS 21MM BIOPROSTHETIC AORTIC VALVE, THE PATIENT DEVELOPED EXSANGUINATING HEMORRHAGE. THE PATIENT WAS EMERGENTLY RE-OPENED AND PLACED ON CARDIOPULMONARY BYPASS (CPB) WITH LARGE VOLUMES OF BLOOD EMANATING FROM A HOLE IN THE INFERIOR SURFACE OF THE HEART CORRESPONDING TO A HEMATOMA. THE LEFT ATRIUM WAS OPENED AND THE AORTIC VALVE LOOKED "FUNDAMENTALLY NORMAL" FROM THE OUTSIDE BUT THE SURGEONS "KNEW WE HAD TO REMOVE IT AND REPLACE IT." A NON-MEDTRONIC BIOPROSTHETIC AORTIC VALVE WAS THEN DEPLOYED, WHICH HELPED COVER THE DISSECTED AREA, AND WAS DEEMED ACCEPTABLE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) SHOWED GOOD VALVULAR FUNCTION AND THE BLEEDING WAS LARGELY CONTAINED, HOWEVER, THE PHYSICIANS DECIDED TO PACK THE CHEST OPEN AND TREAT AN ACQUIRED COAGULOPATHY. THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT (ICU) IN CRITICAL CONDITION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Vascular Dissection

  MAUDE report 12350233 ↗
• InjuryMay 14, 2019Perivalvular Leak; Perivalvular Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH NON-MEDTRONIC VALVE DUE TO PARAVALVULAR LEAK (PVL) (DEGREE NOT SPECIFIED). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8609090 ↗
• InjurySep 18, 2018Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, SIGNIFICANT REGURGITATION OF THE VALVE WAS NOTED AFTER COMING OFF OF THE CARDIOPULMONARY BYPASS. THE PATIENT WAS PLACED BACK ON PUMP, AND THE VALVE WAS EXPLANTED AND REPLACED WITH A 19MM BIOPROSTHETIC VALVE OF A DIFFERENT MODEL. EXAMINATION OF THE EXPLANTED VALVE REVEALED A TORN LEAFLET. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Regurgitation

  MAUDE report 7887226 ↗
• DeathApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION FROM THE PATIENT'S SPOUSE THAT 1 DAY POST IMPLANT OF THIS BIOPROSTHETIC VALVE, THE PATIENT DIED. THE PATIENT WAS VERY SLUGGISH COMING OFF BYPASS SO THEY WENT BACK ON AND DID ADDITIONAL BYPASS GRAFTS HOPING TO IMPROVE HEART FUNCTION. THE PHYSICIAN REPORTED THE CAUSE OF DEATH WAS COAGULOPATHY DUE TO EXCESSIVE PUMP RUN AND THERE WAS NO EVIDENCE TO SUGGEST THAT THE VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. NO AUTOPSY WAS PERFORMED.

  Patient problems: Coagulation Disorder; Death

  MAUDE report 7461815 ↗
• InjuryNov 22, 2017Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information; Inadequacy of Device Shape and/or Size; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 21MM AORTIC BIOPROSTHETIC VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A 19MM VALVE OF THE SAME MODEL. THE REASON FOR THE EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7052255 ↗
• InjuryNov 14, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT THIS 21MM AORTIC BIOPROSTHETIC VALVE WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE. THE DEVICE WAS REPLACED WITH AN 18MM MECHANICAL VALVE FOR UNKNOWN REASONS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7028097 ↗
• InjuryJun 6, 2017Material Rupture; Material Rupture

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY FOLLOWING IMPLANT OF THIS 21MM BIOPROSTHETIC VALVE, THIS VALVE WAS EXPLANTED AND REPLACED AFTER "A TEAR AT THE LEVEL OF THE ANNULUS WAS NOTED" ON THE VALVE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6616565 ↗

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