On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder ONXANE-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851788001648), received between Sep 21, 2016 and Nov 1, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, AN IMPLANT REGISTRATION CARD (IRC) WAS RECEIVED FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT. THE REASON FOR EXPLANT IS CURRENTLY UNKNOWN. THIS VALVE WAS IMPLANTED ON (B)(6) 2018 AND EXPLANTED ON (B)(6) 2024.

  Patient problems: Cardiovascular Dysfunction/Insufficiency; Insufficient Information

  MAUDE report 20588812 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT SUBMITTED BY AN ON-X PATIENT, "I HAD AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPLACEMENT IN FEBRUARY 2022. SZMM 25 SN: (B)(6); SZMM19, SN (B)(6). ACCORDING TO ECHO VALVES ARE NOT WORKING, I STILL HAVE AORTIC STENOSIS AND MITRAL VALVE REGURGITATION, AND NOW TRICUSPID VALVE HAS REGURGITATION. I HAVE SHORTNESS OF BREATH, LOSS OF BALANCE, FATIGUE, AND FEEL WORSE THAN BEFORE SURGERY. I AM NOT HAPPY WITH CURRENT CARDIOLOGIST AND MY SURGEON HAS LEFT AREA." THIS REPORT WILL BE RELEGATED TO ONXANE-19, SN (B)(6). THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.

  Patient problems: Aortic Valve Stenosis; Balance Problems; Dyspnea; Fatigue; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 16911334 ↗
• InjuryFeb 15, 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 FOR ONXANE-23 SN (B)(4), IMPLANTED (B)(6) 2022, WAS RETURNED FROM THE USER FACILITY FOR A PATIENT WITH AN EXISTING ON-X HEART VALVE (ONXANE-19 SN (B)(4) IMPLANTED (B)(6) 2014. BOTH IRCS NOTATE THE VALVES WERE IMPLANTED IN THE AORTIC POSITION SUGGESTING THE ONXANE-19 SN (B)(4) WAS EXPLANTED. THIS INVESTIGATION IS RELEGATED TO ONXANE-19 SN (B)(4).

  Patient problems: Insufficient Information; Valvular Stenosis

  MAUDE report 16378991 ↗
• InjuryMay 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT RECEIVED VIA EMAIL ON 16-JUN-2021, "PATIENT IS SUBJECT # 370 IN THE ON-X POST APPROVAL STUDY. PATIENT WAS HOSPITALIZED FOR A PACEMAKER RELATED REASON. NO OTHER DETAILS ARE AVAILABLE AT THIS POINT." PER THE ADJUDICATION FORM DURING THIS HOSPITALIZATION THE PATIENT HAD A PACEMAKER IMPLANTED. THIS IS NOT RELATED TO THE IMPLANTED ON-X VALVE. ADDITIONAL INFORMATION RECEIVED RELAYED THE PATIENT WAS ADMITTED ON (B)(6) 2019 FOR ELECTIVE LEFT KNEE REPLACEMENT. ON (B)(6) 2019 THE PATIENT AWOKE WITH BILATERAL BLURRY VISION, AND IS BEING EVALUATED FOR STROKE. (B)(6) 2019: CT OF HEAD - OCCIPITAL LOBES WITH BILATERAL HYPODENSITY. RIGHT PARIETAL LOBE HYPODENSITY. SUGGESTIVE OF EVOLVING INFARCTS VS PRES. ASSESSMENT: SUSPECTED ACUTE INFARCTS INVOLVING THE OCCIPITAL + PARIETAL LOBES RELATED TO BEING OFF OF ANTICOAGULATION + MECHANICAL VALVE.

  Patient problems: Stroke/CVA

  MAUDE report 14403660 ↗
• InjuryApr 30, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE INITIAL REPORT, ONXANE-19, SERIAL NUMBER (B)(4) WAS IMPLANTED AND EXPLANTED WITHIN THE SAME PROCEDURE.

  Patient problems: No Information

  MAUDE report 10013846 ↗
• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED THE ON-X AORTIC HEART VALVE WITH ANATOMIC SEWING RING AND EXTENDER HOLDER - 19MM IN (B)(6) 2016 DUE TO SEVERE AI (ASYMPTOMATIC). SHE RETURNED FOR HIP REPLACEMENT WORK WHEN A NEW MURMUR AND AN X-RAY SHOWED SOME PNEUMOPERITONEUM. ECHO SHOWED SEVER AI (VALVE DEHISCENCE) AND LIKELY A VENTRICULAR SEPTAL DEFECT (V. SINUS OF VALSALVA ANEURYSM WITH RUPTURE INTO THE RV) WITH EF 55%, DEPRESSED LV FUNCTION, DEPRESSED RV FUNCTION. THERE WAS NO EVIDENCE OF INFECTION. A SECONDARY STERNOTOMY, REMOVAL OF THE PREVIOUSLY PLACED ON-X AORTIC VALVE, REPAIR (PATCH) SUBAORTIC VENTRICULAR SEPTAL DEFECT, AND REPAIR (PATCH) AORTIC PSEUDOANEURYSM AT THE LEVEL OF THE AORTICOMITRAL CONFLUENCE WAS PERFORMED. AN ON-X AORTIC HEART VALVE WITH ANATOMIC SEWING RING - 21MM WAS IMPLANTED.

  Patient problems: Aortic Insufficiency; Pseudoaneurysm

  MAUDE report 5967522 ↗

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