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On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-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
4
Deaths reported
1
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851788001426), received between Aug 11, 2015 and Apr 26, 2022 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 Problem1
  • Break1
  • Fracture1
  • Insufficient Device Problem Information1
  • Leaflet fracture1

Patient problems

  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Death1
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1
  • Wound Dehiscence1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    ACCORDING TO THE IMPLANT REGISTRATION CARDS RECEIVED, THIS PATIENT WAS IMPLANTED WITH ONXAE-27/29 SN (B)(4) ON (B)(6) 2016 AND EXPLANTED ON (B)(6) 2022. CAUSE OF EXPLANT IS STILL CURRENTLY UNKNOWN.

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

    MAUDE report 14206911 ↗
  • MalfunctionNov 23, 2015Fracture

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 5242937 ↗
  • DeathAug 11, 2015Insufficient Device Problem Information

    EVENT OCCURED IN (B)(6). PATIENT DEATH, POST-OP LATE (5 MONTHS). BACKGROUND: DISEASE ETIOLOGY: PROSTHETIC VALVE (NOT AN ON-X VALVE) DEHISCED DUE TO INFECTIVE ENDOCARDITIS (IE) IN (B)(6) 2012. PATIENT HAD STOPPED TAKING WARFARIN. EMERGENCY RE-DO AORTIC VALVE REPLACEMENT ON (B)(6) 2013 W/ ON-X VALVE. UPON DISCHARGE DATE 12/26/2013, ECHO SHOWED GRADE II AORTIC REGURG. (TRANS + PERIVALVULAR). INR=1.76, NYHA CLASS I, SLDH =205. PATIENT DIED (B)(6) 2014, RECORDED AS VALVE-RELATED DUE TO PREVIOUSLY-DESCRIBED DISEASE ETIOLOGY. IT IS NOT CLEAR IF THE ON-X VALVE ALSO DEHISCED DUE TO IE. ON (B)(6) 2015, ONXLTI RECEIVED A SET OF DATA FROM THE SPONSOR OF A (B)(6) POST-MARKET STUDY, WHERE-IN THEY WANTED ON-X TO DO DATA ANALYSIS ON A SET OF DATA CONTAINING ADVERSE EVENTS. THE VALVE ON THIS MDR IS ONE OF THE AE'S. SEE SCANNED CHART. THERE ARE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN THESE RATES AND THIS TRIAL WAS RUN AT INR OF 1.5 TO 2.5 VERSUS THE PMA AT 2.0 TO 3.0. AT LOWER INR LO RATES ARE EXPECTED BASED ON OUR RESEARCH. SO THESE EVENTS WHILE MDR REPORTABLE AS INDIVIDUAL OCCURRENCES, THEY ARE OVERALL IN THE RANGE EXPECTED.

    Patient problems: Death; Wound Dehiscence

    MAUDE report 5001656 ↗
  • MalfunctionAug 11, 2015Break; Leaflet fracture

    EVENT OCCURRED IN (B)(6). ONE LEAFLET BROKE INTO 2 PIECES, INTRA-OPERATIVELY. KNOW TO BE IATROGENIC. NO ADVERSE EFFECT ON THE PT. FURTHER INFO WILL BE PROVIDED IN A F/U REPORT AFTER DETAILED INVESTIGATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 4999230 ↗

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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