On-X Aortic Heart Valve with Conform-X Sewing Ring ONXACE-27/29Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851788001488), received between Apr 13, 2020 and Jul 3, 2025 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathJul 3, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION ON (B)(6) 2025, "THE PATIENT UNDERWENT SURGERY FOR A MITRAL VALVE REPLACEMENT. A NEW DOCTOR, WHO HAS ONLY RECENTLY STARTED WORKING AT THE HOSPITAL, PERFORMED THE OPERATION. THE SURGEON IS FAMILIAR WITH THE ONX VALVE FROM HIS PREVIOUS WORK AT ANOTHER CLINIC. THE CONSIGNMENT STOCK AT THE HOSPITAL ONLY CONTAINS ONX VALVES FOR THE AORTIC POSITION, DIFFERENT SIZES OF ONXACE. DESPITE THE REQUEST FOR AN ONX MITRAL VALVE, THE OR NURSING STAFF HANDED THE SURGEON AN ONX AORTIC VALVE. NEITHER THE PERSON HANDING OVER THE VALVE, NOR THE STERILE OR NURSE, NOR THE SURGEON NOTICED THAT IT WAS THE WRONG PRODUCT. ACCORDING TO THE REPORTING DOCTOR, IT WAS A HUMAN ERROR ON OF THE ENTIRE SURGICAL TEAM INVOLVED AND THE CASE IS BEING INVESTIGATED INTERNALLY AT THE HOSPITAL NOW. IMAGES OF BOTH THE OUTER PACKAGING AND THE INNER PACKAGING OF THE ONX VALVES WERE REQUESTED FOR THIS PURPOSE."

  Patient problems: Insufficient Information; Ischemia Stroke

  MAUDE report 22394313 ↗
• InjuryMay 19, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO INITIAL REPORTS, PATIENT WITH AN EXISTING ON-X HEART VALVE (ONXACE-27/29, (B)(6) IMPLANTED (B)(6) 2016, RECEIVED ONXACE-25, (B)(6) (B)(6) 2024. THIS INVESTIGATION IS RELEGATED TO ONXACE-27/29, (B)(6) FOR EXPLANT.

  Patient problems: Insufficient Information

  MAUDE report 22047538 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  AN IMPLANT REGISTRATION CARD (ONXACE-27/29 SN (B)(4)) WAS RETURNED FROM THE USER FACILITY FOR A PATIENT WITH AN EXISTING ON-X HEART VALVE (ONXACE-27/29 SN (B)(4)). BOTH IRCS NOTATE THE VALVES WERE IMPLANTED IN THE AORTIC POSITION SUGGESTING THE ONXACE-27/29 SN (B)(4) WAS EXPLANTED. THIS INVESTIGATION IS RELEGATED TO ONXACE-27/29 SN (B)(4).

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 16324682 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE EMAIL RECEIVED FROM AN ON-X PATIENT, "ARE THERE ANY SITES NEAR NE (B)(6)? I AM ON WARFARIN 7.5MG DAILY FOR AN INR 2.5-30 TARGET GOAL. MONITORED CLOSELY BY [HOSPITAL]. MY ONX 29 WAS IMPLANTED IN THE AORTIC POSITION (B)(6) 2012. NUMEROUS CHANGES TO DOSING OVER THE PAST YEARS, AND DIFFICULT BRIDGING EVENTS WHEN PROCEDURES REQUIRED WITHHOLDING THE WARFARIN FOR 5 DAYS PREOP. I RECENTLY WAS BRIDGING MY WARFARIN WITH LOVENOX, WHICH ¿CONTRIBUTED¿ TO A SUBDURAL HEMATOMA. EMERGENCY SURGERY WITH AN EMERGENCY DOSE OF VITAMIN K, RESULTED IN 3 DVTS AND 2 PES. 2 MONTHS OF HOSPITALIZATION AND ANOTHER 2 MONTHS OF REHAB, HAS GOT ME DOING BETTER. I HAVE BEEN WAITING FOR SOME INITIAL RESULTS FROM YOUR (B)(6) STUDY, BUT I BELIEVE ANY RISKS FROM THE SWITCH TO APIXABAN IS OVERSHADOWED BY THE RISKS FROM WARFARIN. LOOKING FORWARD TO LEARNING MORE." THIS INVESTIGATION WILL BE RELEGATED TO ONXACE-27/29, SN (B)(4).

  Patient problems: Hematoma; Pulmonary Embolism; Thrombosis/Thrombus

  MAUDE report 13155514 ↗
• InjuryApr 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, ONXACE-27/29 SN 5403810 WAS IMPLANTED ON (B)(6) 2018, AND REPLACED WITH AN ONXAAP-27/29 ON (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED STATED, "[PATIENT] HAD PROSTHETIC AORTIC VALVE ENDOCARDITIS/DEHISCENCE OF THE AORTIC VALVE PROSTHESIS WITH ROCKING OF THE VALVE, AN AORTIC ROOT ABSCESS, AND MITRAL VALVE ENDOCARDITIS. PROCEDURE WAS MVR AND BENTALL PROCEDURE WITH 29-MM BILEAFLET ON-X MECHANICAL CONDUIT. "

  Patient problems: Endocarditis

  MAUDE report 9953352 ↗

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