Open Pivot™ 505DA20 (UDI 00643169977556)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169977556), received between Aug 16, 2022 and Mar 14, 2024 — classified as 1 death, 1 injury.

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

• DeathMar 14, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 22MM MECHANICAL VALVE, IT WAS EXPLANTED AND REPLACED WITH A 20MM VALVE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED.  IT WAS REPORTED THAT THE PATIENT DIED POST IMPLANT. THE CAUSE OF DEATH WAS AS A RESULT OF COMPLICATIONS DURING SURGERY. THERE WAS NO EVIDENCE TO SUGGEST THAT THE 20MM VALVE OR ITS FUNCTION CONTRIBUTED TO THE PATIENT¿S DEATH. IT IS UNKNOWN WHETHER AN AUTOPSY WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE CAUSE OF DEATH AS MASSIVE CARDIOGENIC REPERFUSION INJURY. IT WAS ALSO REPORTED THAT THE COMPLICATION DURING SURGERY WAS STONE HEART POST LONG PUMP RUN. THE REPLACEMENT WAS REPORTED TO BE MINIMALLY INVASIVE, BUT WAS THEN CONVERTED TO FULL STERNOTOMY DUE TO A SMALL AORTIC ROOT REQUIRING AORTIC ROOT ENLARGEMENT. THE PHYSICIAN SOURCE INDICATES THE EVENT IS NOT PRODUCT RELATED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18907332 ↗
• InjuryAug 16, 2022Inadequacy 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, IT WAS EXPLANTED AND REPLACED WITH AN 18MM DEVICE OF THE SAME MODEL. THE REASON FOR THE REPLACEMENT WAS REPORTED AS INCORRECT SIZE. IT WAS STATED THAT THE 20MM AORTIC MECHANICAL VALVE WAS TOO LARGE FOR THE PATIENT'S ANNULUS AND OBSTRUCTED THE CORONARY ARTERIES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 15234467 ↗

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