Open Pivot™ 505DA18Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169335028), received between Apr 24, 2017 and Apr 1, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT 4 YEARS AND 11 MONTHS POST IMPLANT OF THIS 18MM AORTIC MECHANICAL VALVE AND 29MM MITRAL MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS SINUS BRADYCARDIA. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Bradycardia

  MAUDE report 24752912 ↗
• InjuryMay 13, 2025Insufficient Device Problem Information; Thickening of Material; Device Stenosis; Insufficient Device Problem Information; Thickening of Material; Device Stenosis

  ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE REASON FOR REPLACEMENT AS AORTIC STENOSIS DUE TO PANNUS FORMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Aortic Valve Stenosis; Foreign Body Reaction; Insufficient Information

  MAUDE report 22009985 ↗
• InjuryApr 24, 2023Mechanical Jam; Insufficient Device Problem Information; Mechanical Jam; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT 4 YEARS AND 12 MONTHS POST IMPLANT OF THIS 18MM AORTIC MECHANICAL VALVE, IT WAS EXPLANTED AND RE PLACED WITH A VALVE OF THE SAME MODEL AND SIZE. THE REASON FOR THE REPLACEMENT WAS NOT REPORTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 16795093 ↗
• InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDTRONIC RECEIVED INFORMATION THAT 5 MONTHS POST IMPLANT OF THIS 18MM AORTIC MECHANICAL VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED TO BE DUE TO INCOMPLETE ATRIOVENTRICULAR BLOCK. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Non specific EKG/ECG Changes

  MAUDE report 14269888 ↗
• InjuryMar 15, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS 18MM MECHANICAL AORTIC VALVE, THE PHYSICIAN REPORTED THAT DUE TO ANNULUS BEING VERY CALCIFIED AND A BICUSPID VALVE, THE VALVE WAS TOO LARGE. THE PHYSICIAN ALSO REPORTED THAT THE AORTA WAS "FALLING APART". THE VALVE WAS EXPLANTED AND A ROOT REPAIR PROCEDURE WITH A NON-MEDTRONIC CONDUIT WAS PERFORMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.  NOTE: THIS WAS A MINIMALLY INVASIVE PROCEDURE.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 7343159 ↗
• InjuryAug 23, 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 THIS AORTIC MECHANICAL VALVE WAS IMPLANTED AND EXPLANTED DURING THE PROCEDURE AND WAS REPLACED WITH ANOTHER MECHANICAL VALVE OF THE SAME MODEL. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED

  Patient problems: No Information

  MAUDE report 6814373 ↗
• InjuryApr 24, 2017Device Operates Differently Than Expected; Insufficient Device Problem Information; Device Operates Differently Than Expected; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS MECHANICAL VALVE, THIS VALVE WAS EXPLANTED AND REPLACED. NO FAILURE MECHANISM AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information; Thrombus

  MAUDE report 6517194 ↗

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