On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder ONXAE-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851788001402), received between Aug 11, 2015 and Jul 30, 2020 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Device remains implanted” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2020Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE INITIAL REPORT RECEIVED, THE IMPLANT REGISTRATION CARD FOR ONXAE-23, SN (B)(4) HAD "EXPLANTED" WRITTEN ON IT. AFTER REVIEW OF THE PATIENT'S FILE, THE HOSPITAL NURSE CONFIRMED THE VALVE WAS EXPLANTED DUE TO A CONCERN THAT THE ON-X VALVE WAS OCCLUDING THE LEFT CORONARY ARTERY OR STRETCHING THE PATIENT'S ANNULUS. ADDITIONAL INFORMATION WAS PROVIDED BY THE CRYOLIFE REPRESENTATIVE, "THE VALVE WAS EXPLANTED BECAUSE THE SURGEON COULD NOT SPIN THE VALVE AFTER THE SUTURES WERE IN. THE HIGH POINTS OF THE VALVE WERE BLOCKING THE CORONARIES PER THE SURGEON."

  Patient problems: Occlusion

  MAUDE report 10346333 ↗
• DeathSep 11, 2017Installation-Related Problem; Appropriate Device Problem Term/Code Not Available; Installation-Related Problem; Appropriate Device Problem Term/Code Not Available

  <P>ACCORDING TO THE EMAIL FROM THE DISTRIBUTOR, "WE HAVE A VERY VERY BIG PROBLEM TODAY PROF (B)(6) THE MAIN CONSULTANT FOR ARMY, THE MAN, WE MET HIM ON THE PRIVATE HOSPITAL WERE GOING TO IMPLANT A AORTIC VALVE SIZE 23 THE VALVE LEAFLET WERE INSERT IN THE OPPOSITE DIRECTION AS IF IT IS MITRAL VALVE." PICTURE OF VALVE CASE PROVIDED. VIDEO OF VALVE ON HOLDER FROM SURGEON. ADDITIONAL INFORMATION FROM THE DISTRIBUTOR STATES, "THE CASE WAS FOR A PATIENT ((B)(6)) NEED 3 CORONARY ARTERIES SURGERY [CABG, CORONARY ARTERY BYPASS GRAFTING] AND AORTIC VALVES REPLACEMENT. WHEN PROF DR (B)(6) START TO REPLACE THE VALVE AND AS HE IMPLANT OVER 200 ONX VALVES HE SAW THAT THE VALVE HAVE SOME THING WRONG THE SHAPE OF SWING COUGH IS NOT AS HE ADAPTED HE THINK THAT IT IS MITRAL AND ASK FOR VALVE BOX WHICH WAS FOR AORTIC 23. HE START TO IMPLANT AND PLACE THE VALVES, AFTER FINISH HE TEST THE LEAFLET FIND THAT IT IS IN THE OPPOSITE DIRECTION HE SQUEEZE THE HEART TO SEE HOW BLOOD WILL GO IN THE VALVE THEN TO THE AORTA (HE IS VERY EXPERT SURGEON), HE FIND LEAFLET CLOSE NO BLOOD WILL MOVE WHICH MEANS THAT HEART WILL CONTRACT AGAINST CLOSE VALVE. IF HE DO NOT DID SEE TEST AND HE SEPARATE THE PATIENT FROM HEART

  Patient problems: Cardiogenic Shock; Death

  MAUDE report 6854756 ↗
• InjuryMar 9, 2016Perivalvular Leak

  PATIENT HAD AORTIC VALVE REPLACEMENT (AVR) ON (B)(6) 2015. OVER 4 MONTHS POST-OPERATIVE, HE DEVELOPED PARAVALVULAR LEAK (PVL). IT WAS OBSERVED IN FOLLOW-UP ECHOS AND MONITORED FOR SEVERAL WEEKS, AFTER WHICH IT WAS DECIDED TO GO THROUGH A RE-DO AVR TO CORRECT THE PVL. THE PATIENT DID NOT EXHIBIT ASSOCIATED SYMPTOMATOLOGY (E.G., HEART FAILURE). THE OPERATIVE FINDINGS WERE THAT THE SURGEON COULD NOT FIND ANY PATHOLOGY AND THE LEAK AND PARAVALVULAR PROBLEM COULD NEVER BE IDENTIFIED. THE LEAK WAS DESCRIBED AS MODERATE AT MOST BY VOLUMETRIC ANALYSIS. THE RE-DO AVR WAS PURSUED ANYWAY. THIS IS BEING REPORTED BECAUSE PVL IS DEFINED IN THE AATS/STS GUIDELINES AS VALVE-RELATED AND REPORTABLE. PVL IS AMONG THE EXPECTED ADVERSE EVENTS THAT CAN OCCUR IN A HEART VALVE PATIENT, AS LISTED IN SECTION 5 OF THE IFU. PVL IS OCCURRING WELL-WITHIN EXPECTED FREQUENCY AND NO TREND IS SEEN. PATIENT STATUS: PATIENT IS STATUS POST 2ND AVR, IS CURRENTLY ASYMPTOMATIC SHOWING NO CLINICAL SEQUELAE AT THIS TIME. SHOWING ECHO EVIDENCE OF RE-OCCURRENCE OF PVL MILD.

  Patient problems: Aortic Insufficiency

  MAUDE report 5488426 ↗
• DeathAug 11, 2015Device remains implanted; Adverse Event Without Identified Device or Use Problem

  THIS IS THE SECOND MDR FOR THIS DOUBLE-VALVE REPLACEMENT CASE. MOST OF THE INFORMATION IS THE SAME AS IN MDR # 1649833-15-17. EVENT OCCURRED IN (B)(6). 10TH POST-OP DAY, PATIENT DEATH. JUDGED AS OPERATIVE MORTALITY, PROBABLY "SUDDEN". BACKGROUND: JUDGED AS OPERATIVE MORTALITY, PROBABLY "SUDDEN". BACKGROUND: DOUBLE-VALVE PATIENT. DISEASE ETIOLOGY: ENDOCARDITIS. NYHA CLASS III. MITRAL REGURGITATION AND AORTIC REGURGITATION. EMERGENCY VALVE REPLACEMENT, AORTIC AND MITRAL. PATIENT NOT ON ANTICOAGULATION ON SURGERY DATE. ON JULY 21, 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. 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

  MAUDE report 5001655 ↗

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