Open Pivot™ 505DA16 (UDI 00643169335035)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169335035), received between Apr 20, 2017 and Nov 13, 2020 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 5 YEARS AND 4 MONTHS POST IMPLANT OF THIS 16MM MECHANICAL AORTIC VALVE, IT WAS EXPLANTED AND REPLACED WITH A 18MM MECHANICAL VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; No Information

  MAUDE report 10835772 ↗
• DeathApr 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT TWO DAYS FOLLOWING THE IMPLANT OF THIS MECHANICAL AORTIC VALVE, THIS PATIENT EXPIRED. THE PHYSICIAN NOTED IN THE OPERATIVE NOTES THAT THE PATIENT HAD A VERY DIFFICULT ANATOMY TO OPERATE ON. NEAR THE END OF THE PROCEDURE, THERE WAS REPORTEDLY A CLOT FORMATION AT THE END OF THE PATIENT'S ENDOTRACHIAL TUBE WHICH MADE IT IMPOSSIBLE TO VENTILATE. THIS LED TO A SERIES OF COMPLICATIONS WHERE, BECAUSE THE TUBE WAS SO SMALL IT WAS DIFFICULT TO EVACUATE ANYTHING OUT OF IT. THE ENDOTRACHIAL TUBE WAS EVENTUALLY CLEARED AND VENTILATION RESUMED, BUT NOT BEFORE THE PATIENT EXPERIENCED POOR BLOOD GASES, HYPOVENTILATION AND HYPOTENSION. THE PATIENT WAS MOVED TO THE INTENSIVE CARE UNIT AND SUBSEQUENTLY EXPIRED 2 DAYS POST VALVE IMPLANT. NO DEVICE FAILURE MECHANISM, NO DEVICE INVOLVEMENT, AND NO SPECIFIC CAUSE OF DEATH WAS REPORTED.

  Patient problems: Death; Hypoventilation; Low Blood Pressure/ Hypotension

  MAUDE report 6508640 ↗

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