On-X Ascending Aortic Prosthesis ONXAAP-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851788001518), received between Jun 15, 2022 and Jan 29, 2024 — classified as 6 injuries.

4 other recalls cover devices cleared under the same FDA submission (P000037); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION,"PATIENT IS IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2011 WITH A PREFABRICATED AAP DEVICE SN #(B)(6). ON (B)(6) 2015 (1.357 DAYS POST IMPLANT) WAS ADMITTED TO THE HOSPITAL WITH DIAGNOSIS OF CVA. INR WAS 1.5 PER MEDICAL RECORDS AT TIME OF HOSPITALIZATION. AN ECHOCARDIOGRAM WAS PERFORMED ON (B)(6) 2015 AFTER THIS EVENT SHOWING AVR ON-X 21MM WELL SEATED AND FUNCTIONING, PEAK OF 26MM AND MEAN OF 18MMHG AND NO MENTION OF VEGETATION. SHE WAS DISCHARGED ON 6APRIL2015 ON LOVENOX AND INCREASED INR RANGE OF 2.0-3.5. NO FURTHER MEDICAL INFORMATION AVAILABLE DUE TO LIMITED MEDICAL RECORDS PROVIDED."

  Patient problems: Stroke/CVA

  MAUDE report 18594664 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, STUDY PATIENT EXPERIENCED ACUTE RENAL FAILURE ON (B)(6) 2022, 1-DAY FOLLOWING IMPLANT WITH THE DEVICE (IMPLANTED ON (B)(6) 2022).

  Patient problems: Renal Failure

  MAUDE report 15933807 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, STUDY PATIENT EXPERIENCED A HEMORRHAGIC STROKE ON (B)(6) 2022, 7-DAYS FOLLOWING IMPLANT WITH THE DEVICE (IMPLANTED ON (B)(6) 2022).

  Patient problems: Hemorrhagic Stroke

  MAUDE report 15933756 ↗
• InjuryDec 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, STUDY PATIENT EXPERIENCED AN ISCHEMIC STROKE ON (B)(6) 2022, 1-DAY FOLLOWING IMPLANT WITH THE DEVICE (IMPLANTED ON (B)(6) 2022).

  Patient problems: Ischemia Stroke; Stroke/CVA; Thromboembolism

  MAUDE report 15933004 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON-X ASCEND STUDY PATIENT (B)(6) EXPERIENCED CARDIAC ARREST ON (B)(6) 2022 WHICH LED TO A SERIOUS DETERIORATION IN THE HEALTH OF THE PATIENT AND PROLONGED THEIR HOSPITALIZATION. RE-OPERATION WAS PERFORMED ON (B)(6) 2022. CABG (CORONARY ARTERY BYPASS GRAFT) COMPLETED WITH THE REANASTAMOSIS OF THE RIGHT CORONARY ARTERY BYPASS GRAFT DUE TO CONCERN ABOUT COMPROMISE TO THE BLOOD FLOW TO THE RIGHT CORONARY ARTERY. THE ON-X VALVE REMAINS IMPLANTED. OUTCOME OF THE RE-OPERATION IS SYMPTOMS RESOLVED WITHOUT SEQUELAE.

  Patient problems: Cardiac Arrest

  MAUDE report 15870265 ↗
• InjuryJun 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN PERFORMING A PAPER CASE REPORT FORM (CRF) REVIEW OF THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY, THE FOLLOWING ADVERSE EVENT WAS DISCOVERED FOR SUBJECT (B)(6): ON 09JUN2015 6 DAYS POST IMPLANT, SUBJECT EXPERIENCED COMPLETE HEART BLOCK AND HAD A PERMANENT PACEMAKER IMPLANTED. THE SUBJECT WAS DISCHARGED THE FOLLOWING DAY.

  Patient problems: Heart Block

  MAUDE report 14708306 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P000037. One submission often covers many models, so check the product and lot details in each record.

• Z-2133-2026 · Feb 1, 2026 · Open, Classified
  On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
• Z-1073-2019 · Jan 17, 2019 · Terminated
  On-X Aortic Heart Valve with Anatomic Sewing Ring Product Usage: The On-X Prosthetic Heart Valve is indicated for the replacement of diseased, damaged, or malfunctioning native
• Z-2715-2017 · Jun 12, 2015 · Terminated
  On-X Prosthetic Heart Valve Product Usage: Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic and mitral positio
• Z-3108-2017 · Feb 12, 2014 · Terminated
  On-X Prosthetic Heart Valve with Gelweave Valsalva Graft, single use. Indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in th