On-X Ascending Aortic Prosthesis ONXAAP-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00851788001501), received between Dec 20, 2022 and Mar 2, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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

Recent adverse event reports

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

• InjuryMar 2, 2026Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION ON (B)(6) 2026, "DURING THE AAP IMPLANTATION THEY NOTICED THAT THE EXCESS TISSUE THAT WAS PREVENTING THE VALVE LEAFLETS FROM FUNCTIONING PROPERLY HAD NOT BEEN REMOVED, SO THE NEEDED TO CUT IT, NOT EASY TO DO ESPECIALLY IN A 19 MM DIAMETER, AND IT PROLONGED SURGERY BY ALMOST ONE HOUR." THIS INVESTIGATION IS RELEGATED TO ONXAAP-19, SN (B)(6) WITH ALLEGATION OF EXCESS MATERIAL PREVENTING VALVE LEAFLETS FROM FUNCTIONING PROPERLY. ADDITIONAL INFORMATION RECEIVED FROM REP 02/12/2026: "I HAVE A FEW MORE QUESTIONS FOR THE SURGEON REGARDING THIS EVENT: 1. IS THIS PICTURE EXACTLY WHAT THE SURGEON WAS LOOKING AT IN A UN-ALTERED ON-X AAP AS IT WAS SUPPLIED RIGHT FROM THE BOX AND INTO THE PATIENT? OR. 2. DID THE SURGEON CUT THE SUPPLIED VALSALVA GRAFT AWAY FROM THE ON-X SIZE 19MM VALVE AND THEN ATTEMPT TO SEW ON A DIFFERENT GRAFT? UNFORTUNATELY, YOUR FIRST OPTION."

  Patient problems: Insufficient Information

  MAUDE report 24483029 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE IMPLANT REGISTRATION CARD RETURNED FOR AN ONXAAP - 23, THE PATIENT HAD THE ONXAAP - 23 IMPLANTED IN THE AORTIC POSITION ON (B)(6) 2022. THE ON-X DEVICE TRACKING SYSTEM SHOWED THIS PATIENT HAD A ONXAAP - 19 IMPLANTED ON (B)(6) 2020 IN THE AORTIC POSITION. THIS INVESTIGATION IS RELEGATED TO THE ONXAAP-19 SERIAL NUMBER: (B)(4).

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

  MAUDE report 16013442 ↗

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