Open Pivot™ 505DA20 (UDI 00643169335011)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169335011), received between Feb 23, 2017 and Nov 26, 2024 — classified as 1 death, 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 reports).

2 other recalls cover devices cleared under the same FDA submission (P990046); 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT POST IMPLANT OF THIS 20 MM MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT P ACEMAKER WAS REPORTED AS COMPLETE HEART BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Heart Block

  MAUDE report 20783059 ↗
• InjuryNov 22, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 DAYS POST IMPLANT OF THIS 20MM AORTIC MECHANICAL 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 20761421 ↗
• InjuryOct 15, 2024Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis; Insufficient Device Problem Information; Patient Device Interaction Problem; Device Stenosis

  MEDTRONIC RECEIVED INFORMATION THAT 3 YEARS AND 8 MONTHS POST IMPLANT OF THIS 20MM AORTIC MECHANICAL VALVE AND 27MM MITRAL MECHANICAL VALVE, THEY WERE EXPLANTED AND REPLACED WITH A 23MM AORTIC BIOPROSTHETIC VALVE AND 27MM MITRAL BIOPROSTHETIC VALVE RESPECTFULLY. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Chest Pain; Dyspnea; Insufficient Information; Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 20449415 ↗
• InjuryOct 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT IMMEDIATELY POST IMPLANT OF THIS 20MM MECHANICAL AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE OF THE SAME SIZE AND MODEL. THE REASON FOR REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10765501 ↗
• DeathApr 22, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 2 DAYS FOLLOWING THE IMPLANT OF THIS MECHANICAL VALVE, THE PATIENT DIED. THE CAUSE OF DEATH WAS NOT RECEIVED. 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. IT WAS REPORTED THE AORTIC AND MITRAL VALVES WERE REPLACED FOLLOWING THE EXPLANT OF A TRANSCATHETER AORTIC VALVE (TAV) WHICH WAS EXPLANTED DUE TO STENOSIS AFTER THREE YEARS IMPLANT DURATION. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Death

  MAUDE report 9985473 ↗
• InjuryAug 29, 2019Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 20MM AORTIC MECHANICAL VALVE, THE VALVE WAS TOO LARGE FOR THE ANNULUS DUE TO ABNORMAL CORONARY OSTIA. THEREFORE, THE VALVE WAS EXPLANTED AND REPLACED WITH AN 18MM AORTIC MECHANICAL VALVE OF THE SAME MODEL. THE PHYSICIAN REPORTED THERE WAS NO ISSUE WITH THE MECHANICAL VALVE AND NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8945770 ↗
• InjuryJun 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MECHANICAL VALVE, THE VALVE WAS IMPLANTED AND EXPLANTED. THE REASON FOR EXPLANT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8715948 ↗
• MalfunctionSep 5, 2018Fire; Fire

  ACCORDING TO THE REPORTER, A MALE WAS PRESENTED FOR A LEFT KIDNEY TRANSPLANT. A FLAME WAS OBSERVED AT THE TIP OF THE PEN DURING THE ONSET OF THE PROCEDURE. THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT AT THE TIME THE FLAME OCCURRED AND WAS EXTINGUISHED WITHIN SECONDS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7846573 ↗
• InjuryMay 4, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH A VALVE OF A LARGER SIZE. THE REASON FOR REPLACEMENT WAS DUE TO A SIZING ERROR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7488469 ↗
• InjuryApr 30, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 20MM MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH AN 18MM VALVE OF THE SAME MODEL. THE REASON FOR REPLACEMENT WAS REPORTED AS A SIZING ISSUE DUE TO A DOUBLE VALVE PROCEDURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 7473952 ↗
• InjuryApr 16, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 20 MM MECHANICAL VALVE, THE VALVE WAS EXPLANTED AND REPLACED WITH AN 18 MM VALVE AS THE PHYSICIAN DEEMED THE 20 MM VALVE WAS THE WRONG SIZE FOR THE PATIENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7432547 ↗
• InjurySep 11, 2017Inadequacy of Device Shape and/or Size; Incomplete Coaptation; Inadequacy of Device Shape and/or Size; Incomplete Coaptation

  MEDTRONIC RECEIVED INFORMATION THAT THIS 20MM AORTIC MECHANICAL VALVE WAS IMPLANTED AND EXPLANTED DURING THE SAME PROCEDURE AND WAS REPLACED WITH AN 18MM MECHANICAL VALVE OF THE SAME MODEL. POST IMPLANT OF THE 20MM VALVE SHOWED VERY SMALL LEFT VENTRICULAR OUTFLOWTRACT (LVOT) AND HALF OF THE VALVE ORIFICE APPEARED TO BE OBSTRUCTED BY THE RECONSTRUCTED AORTOMITRAL CURTAIN. THE PHYSICIAN THEN DECIDED TO FURTHER AUGMENT THE ANNULUS BY PERFORMING A ROOT REPLACEMENT. THE VALVE WAS REMOVED BY CUTTING THE SUTURES AND THE ORIFICES OF THE PROXIMAL SITES OF THE GRAFTS WERE TRIMMED. THE 20MM VALVE WAS ONCE AGAIN IMPLANTED AND SUTURED INTO PLACE. VALVE INSPECTION THEN NOTED THAT ONE OF THE LEAFLETS HAD BECOME IMMOBILE DUE TO BULGING OF THE LVOT TISSUE. THE VALVE WAS REMOVED AND AN 18MM VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Occlusion

  MAUDE report 6855666 ↗
• InjuryFeb 23, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 1 YEAR 9 MONTHS POST IMPLANT OF THIS AORTIC MECHANICAL VALVE, THE DEVICE WAS EXPLANTED AND REPLACED WITH A MECHANICAL VALVE FOR UNKNOWN REASONS. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 6354496 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990046. One submission often covers many models, so check the product and lot details in each record.

• Z-1533-2020 · Feb 11, 2020 · Terminated
  Medtronic Open Pivot Aortic Valve Graft, REF 502AG25, SIZE 25 mm
• Z-0634-04 · Feb 18, 2004 · Terminated
  ATS Open Pivot Mechanical Heart Valve