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

On-X Life Technologies, Inc. · The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The orifice inflow area has a flared inlet designed to reduce flow turbulence, and the outflow rim consists of leaflet guards designed to protect the leaflets while in the closed position. The leaflets rotate around tabs located within the inner circumference of the orifice ring. In the closed position, each leaflet forms a nominal angle of 40º relative to the plane of the orifice. In the open position, the plane of each leaflet forms a nominal angle of 90deg relative to the plane of the orifice. The leaflets have a travel arc of 50deg to the closed position. The orifice, or housing, is composed of a graphite substrate coated with On-X® Carbon, a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X® Carbon deposited on a graphite substrate, which is impregnated with 10 weight% tungsten to provide radiopacity. The sewing cuff is constructed of polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium retaining rings and 5-0 suture material. This form of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during implantation. Orientation reference marks are provided on the sewing cuff for valve orientation. The On-X® Prosthetic Heart Valve is available in 3 aortic and 2 mitral sewing cuff configurations. Aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. The standard mitral cuff is available in sizes 23, 25, 27/29 and 31/33, while the Conform-X® mitral cuff is available in size 25/33 only. Further detail for the On-X prosthetic heart valve is described in the Summary of Safety and Effectiveness documents for the On-X heart valves: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf (aortic), and http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf (mitral). · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851788001259), received between Mar 31, 2016 and Oct 3, 2016 — classified as 1 death, 1 injury.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Death1
  • No Code Available1
  • Patient Problem/Medical Problem1
  • Thrombosis1

Recent adverse event reports

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

  • InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS IMPLANTED WITH ON-X AORTIC HEART VALVE WITH STANDARD SEWING RING - 27/29MM ON (B)(6) 2014. THE PATIENT HAD A PERIVALVULAR LEAK (PVL) AND THE VALVE WAS EXPLANTED ON (B)(6) 2016; ON-X AORTIC HEART VALVE WITH ANATOMIC SEWING RING - 23MM WAS IMPLANTED AT THAT TIME. AS OF THE LAST VISIT WITH THE SURGEON'S OFFICE ON (B)(6) 2016, THE PATIENT WAS DOING WELL AND HAD RETURNED TO FULL ACTIVITY. THERE WERE NO COMORBIDITIES PRESENTING.

    Patient problems: No Code Available

    MAUDE report 5995194 ↗
  • DeathMar 31, 2016Adverse Event Without Identified Device or Use Problem

    DR. (B)(6), (B)(4). MEDICAL DIRECTOR, REPORTED TO ON-X THAT HE HAD BEEN REVIEWING RECORDS OF A (B)(6) VASCULAR DONOR WHO HAD RECEIVED A 27MM ON-X VALVE IN 2007. THE PATIENT WAS DOING WELL AFTER THE HEART VALVE SURGERY, BUT DIED SUDDENLY ON (B)(6) 2015. THE AUTOPSY SHOWED AN ACUTE THROMBUS IN A CORONARY ARTERY. PATIENT HAD NO SIGNIFICANT CORONARY ARTERY DISEASE. THE AUTOPSY DOES NOT SPECIFICALLY ALLEGE THAT THE VALVE WAS THE SOURCE OF THE THROMBUS, BUT OF COURSE THAT IS ONE OF THE KNOWN RISKS FOR MECHANICAL VALVES. THROUGHOUT THE PATIENT'S MEDICAL RECORDS, THE HEART VALVE IS SHOWN TO FUNCTION NORMALLY. THE ON-X VALVE WAS NOT EXPLANTED, REMAINS WITHIN THE DECEASED. THIS IS BEING REPORTED BECAUSE IT IS DEFINED AS A VALVE-RELATED ADVERSE EVENT PER AATS/STS GUIDELINES, AND IS AMONG A LIST OF ADVERSE EVENTS POSSIBLE WITH HEART VALVE PATIENTS AS LISTED IN SECTION 5 OF THE IFU.

    Patient problems: Death; Patient Problem/Medical Problem; Thrombosis

    MAUDE report 5539435 ↗

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

Other Heart-Valve, Mechanical devices

All Heart-Valve, Mechanical devices →

Sources and updates

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