On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-19Recalls & 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
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851788001389), received between Sep 21, 2020 and Apr 15, 2024 — classified as 1 death, 3 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
Patient problems
- Obstruction/Occlusion3
- Valvular Insufficiency/ Regurgitation2
- Death1
- Thrombosis/Thrombus1
- Unspecified Heart Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL NOTIFICATION VIA EMAIL ON 04/04/2024 , ¿RECEIVED IMPLANT REGISTRATION CARD FOR PATIENT WITH EXISTING AORTIC IMPLANT. PLEASE CONFIRM THAT THIS IS AN EXPLANT.¿ ADDITIONAL INFORMATION RECEIVED 04/10/2024- ¿THERE WAS NO ALLEGED VALVE DEFICIENCY PER SE; DOCTOR DID FIND SUB ANNULAR PANNUS FORMATION ABOUT 1MM IN LENGTH. PATIENT PANNUS SURGEON THOUGHT DUE TO EXTENSIVE ROOT ENLARGEMENT NEEDED TO DO EVEN THE FIRST ONX 19MM REPLACEMENT. PATIENT IS DOING VERY WELL NOW & SURGEON NOR HOSPITAL OPEN TO SENDING IN OP NOTES. NO, VALVE WAS NOT KEPT."
Patient problems: Obstruction/Occlusion; Unspecified Heart Problem
MAUDE report 19105299 ↗InjuryOct 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORT RECEIVED, "[SURGEON] SAID HE IMPLANTED AN ON-X VALVE IN HIS PATIENT IN 2015. PATIENT WAS DOING FINE BUT STARTED TO HAVE HIGH GRADIENTS AROUND 40. THEY MONITORED BUT GRADIENTS STAYED HIGH. ALSO SAID THAT ONE LEAFLET ON THE VALVE LOOKS LIKE IT ONLY OPENS TO 67 DEGREES AND 80 DEGREES FOR THE OTHER. HE ASKED IF THIS WAS ABNORMAL FOR THE LEAFLET OPENING ANGLES AND WHAT TO DO IF THROMBUS SUSPECTED."
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus; Valvular Insufficiency/ Regurgitation
MAUDE report 18015756 ↗InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORT RECEIVED, AN ON-X VALVE IMPLANTED IN 2017 WAS EXPLANTED AND REPLACED DUE TO PANNUS GROWTH.
Patient problems: Obstruction/Occlusion; Valvular Insufficiency/ Regurgitation
MAUDE report 15066693 ↗DeathSep 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE INITIAL REPORT RECEIVED, "[...] FROM CHILDREN¿S HOSPITAL IN OMAHA CALLED TO INFORM US OF A PATIENT DEATH. THIS [PATIENT] DIED ON (B)(6) 2020 FROM CONGESTIVE HEART FAILURE AND RENAL FAILURE."
Patient problems: Death
MAUDE report 10560553 ↗
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, ClassifiedOn-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
- Z-1073-2019 · Jan 17, 2019 · TerminatedOn-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 · TerminatedOn-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 · TerminatedOn-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
- On-X Mitral Heart Valve with Conform-X Sewing Ring ONXMC-25/33On-X Life Technologies, Inc. · Heart-Valve, Mechanical1 recall1 death34 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths70 reports
- SJM Regent™ AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL5 deaths66 reports
- SJM Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths44 reports
- CARBOMEDICS SUPRA-ANNULAR (TOP HAT) S5-021Corcym Srl · HEART-VALVE, MECHANICAL7 deaths37 reports
- Regent™ 21AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL3 deaths35 reports
- Regent™ 23AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL2 deaths33 reports
- Regent™ 19AGFN-756St. Jude Medical, Inc. · HEART-VALVE, MECHANICAL31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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