On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00851788001419), received between Aug 11, 2015 and May 6, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 25APRIL2024 RECEIVED IRC (IMPLANT REGISTRATION CARD) FOR A PATIENT WITH EXISTING AORTIC IMPLANT. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM ARTIVION FIELD REPRESENTATIVE VIA SURGEON'S PA (PHYSICIAN ASSISTANT), "PHYSICALLY ACTIVE GENTLEMAN UNDERWENT AORTIC VALVE REPLACEMENT WITH A ON X PROSTHESIS IN (B)(6) 2018. HE DEVELOPED HEART BLOCK SHORTLY POSTOP REQUIRING PERMANENT PACEMAKER. IN (B)(6) OF 2023 HE PRESENTED WITH THE ACUTE ONSET OF ABDOMINAL PAIN WHICH WAS EVENTUALLY IDENTIFIED AS A SPLENIC INFARCT. ASSESSMENT OF HIS AORTIC VALVE HAS DEMONSTRATED PARTIAL LOCALIZED DEHISCENCE OF THE ANNULAR ATTACHMENT IN THE AREA BELOW THE LEFT MAIN CORONARY AND IN THE AORTA MITRAL CONTINUITY. WHILE THE MOST LIKELY ETIOLOGY FOR SUCH FINDING IS ENDOCARDITIS WHICH MAY HAVE CONTRIBUTED TO THE SPLENIC INFARCTS, TREATMENT ULTIMATELY WOULD INVOLVE DEBRIDEMENT OF THE VALVE AND OF THE AORTIC ROOT COMPLEX. VENTRICULAR FUNCTION OVERALL HAS REMAINED PRESERVED. I FEEL HE MEETS CRITERIA TO RECOMMEND RE-EXPLORATION WHICH WOULD CONSIST OF DEBRIDEMENT OF THE ROOT AND PROSTHETIC AORTIC VALVE AND AORTIC ROOT RECONSTRUCTION. I WOULD STILL IMPLANT AND ON X ME

  Patient problems: Endocarditis

  MAUDE report 19247439 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL REPORT, AN IMPLANT REGISTRATION CARD FOR ONXANE-27/29 WAS RECEIVED. THIS PATIENT HAD AN EXISTING ONXAE-25, SN (B)(6) IMPLANTED. POSSIBLE AORTIC REDO.

  Patient problems: Insufficient Information

  MAUDE report 17255479 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, THIS VALVE WAS IMPLANTED ON (B)(6) 2022 AND REPLACED ON (B)(6) 2023 DUE TO ENDOCARDITIS.

  Patient problems: Endocarditis

  MAUDE report 17197483 ↗
• Apr 21, 2016Perivalvular Leak; Perivalvular Leak

  PATIENT CONTACTED ON-X BY EMAIL ON (B)(6) 2016, EXPRESSING CONCERN THAT HIS CARDIOLOGIST HAD APPARENTLY DONE A FOLLOW-UP ECHO AND DIAGNOSED THAT HE HAD 2 LEAKS AROUND THE NEWLY-IMPLANTED VALVE AT 1 WEEK POST-OP. HE STATED HIS SURGEON DID NOT AGREE, AND HE HAS SOUGHT A SECOND OPINION FROM MAYO CLINIC, ON HIS OWN INITIATIVE. HE WAS CONCERNED BECAUSE IT APPEARED TO HIM THAT HE MIGHT HAVE TO UNDERGO A RE-OPERATION. THE PATIENT WAS REQUESTING THE INTERVENTION OF ONXLTI WITH HIS MEDICAL PROVIDERS. ONXLTI ATTEMPTED TO HAVE THE PATIENT AUTHORIZE RELEASE OF HIS MEDICAL RECORDS ASSOCIATED WITH THE LEAK DIAGNOSIS. THE PATIENT APPEARS TO BE ASYMPTOMATIC RELATIVE TO A PARAVALVULAR LEAK (PVL) DIAGNOSIS. ONXLTI WAS PURSUING THE RECORDS/ECHOS SO THAT THEY COULD BE READ BY AN INDEPENDENT MEDICAL EXPERT TO SEE IF THE CHARACTERISTIC LEAKAGE JETS ASSOCIATED WITH THE PIVOT WASHING (AN INTENTIONAL DESIGNED-IN FEATURE OF THE ON-X VALVE) WERE POSSIBLY BEING MISTAKEN FOR PVL. HOWEVER, THE PATIENT HAS NOT BEEN RESPONSIVE TO OUR REQUESTS FOR APPROVAL TO RELEASE THE RECORDS. THE VALVE REMAINS IMPLANTED. THIS IS BEING REPORTED BECAUSE A PVL EVENT MAY HAVE OCCURRED. PVL IS AN EXPECTED ADVERSE EVENT, FORMALLY DE

  Patient problems: No Information

  MAUDE report 5596879 ↗
• Aug 11, 2015Insufficient Device Problem Information

  EVENT OCCURRED IN (B)(6). PERIPHERAL THROMBOEMBOLISM, POST-OPERATIVE-EARLY. PT COMPLAINED OF SUDDEN PAIN IN RIGHT LOWER LIMB ON (B)(6). EMERGENCY THROMBECTOMY WAS PERFORMED. ECHO DID NOT REVEAL APPARENT THROMBOSED VALVE, NO INTRACARDIAC THROMBUS WAS OBSERVED. HOLTER EKG DETECTED FREQUENT PAC'S (PREMATURE ATRIAL CONTRACTIONS). INR ON DATE OF EVENT WAS SUBTHERAPEUTIC AT 1.45. HEART VALVE REMAINS IMPLANTED AND FUNCTIONING NORMALLY. THIS EVENT FALLS WITHIN THE DEFINITIONS IN THE AATS/STS GUIDELINES AS A VALVE-RELATED EVENT AND IS THEREFORE REPORTABLE. IT IS AN EXPECTED ADVERSE EVENT, AS DEFINED IN THE OBJECTIVE PERFORMANCE CRITERIA IN FDA HEART VALVE GUIDANCE, AND ISO 5840, AND THIS OCCURRENCE IS WITHIN EXPECTED RATE. NO TREND IS SEEN. 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. ONCE ANALYZED AGAINST THE ENTIRE POPULATION IN THE (B)(6) STUDY (ONLY AVR HAS ENOUGH DATA FOR PROPER ANALYSIS) AND THEN COMPARING TO THE PMA. YOU GET THE FOLLOWING RESULTS. EVENT: THROMBOEMBOLISM, (B)(6) STUDY (%/PTYR): 0.71, PMA ST

  Patient problems: Pain

  MAUDE report 5000656 ↗

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