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

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00851788001471), received between Feb 17, 2016 and Aug 12, 2025 — classified as 12 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT RECEIVED, PATIENT EXPERIENCED A MYOCARDIAL INFARCTION ON (B)(6) 2019.

  Patient problems: Myocardial Infarction

  MAUDE report 22783238 ↗
• InjuryAug 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT RECEIVED, PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT (CVA) ON (B)(6) 2025.

  Patient problems: Brain Injury; Embolism/Embolus; Stroke/CVA; Unspecified Heart Problem

  MAUDE report 22782990 ↗
• InjuryMay 22, 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 WAS RECEIVED BACK FROM THE USER FACILITY NOTATING AN ON-X AORTIC VALVE WAS IMPLANTED INTO AN EXISTING ON-X PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS INVESTIGATION WILL BE RELEGATED TO ONXACE-25, 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: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 16973526 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "PATIENT IS IN THE (B)(6) STUDY. HE ATTENDED THE HOSPITAL (EMERGENCY DEPARTMENT LIKELY) WITH HEADACHES, DIAGNOSED WITH TRANSIENT ISCHAEMIC ATTACK / MATURE LACUNAR INFARCTS R CAUDATE. NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE; NEUROLOGY RECORD REQUESTED FROM THE SITE."

  Patient problems: High Blood Pressure/ Hypertension; Stroke/CVA; Thromboembolism

  MAUDE report 12917285 ↗
• InjuryApr 18, 2017Adverse 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 REP REPORT, "RECENTLY, I HAD HEARD THAT SOMETHING MAY HAVE HAPPENED TO THE PATIENT. TODAY, I HEARD FROM THE DOCTOR THAT THE PATIENT HAD A STROKE ROUGHLY 24-36 HRS AFTER THE HEART VALVE WAS IMPLANTED [ON (B)(6) 2017]." AFTER SURGERY HE WOKE UP AND MOVED EVERYTHING. DAY 2 AFTERNOON HE STOPPED MOVING THE LEFT SIDE. CT SHOWED MULTIPLE EMBOLIC STROKE." THE FOLLOWING WAS REQUESTED FROM THE REP IN PREPARATION FOR MEETING WITH THE SURGEON: PROPOSED ETIOLOGY OF EVENT, ANTICOAGULATION REGIMEN IMMEDIATELY POSTOP, PERTINENT PATIENT COMORBIDITIES, PLANNED INTERVENTIONS, CURRENT PATIENT STATUS, AND IF IMPLANT/INTERVENTION NOTES WERE AVAILABLE. AFTER MEETING WITH THE SURGEON, THE REP STATED "THE PATIENT HAS NOT COME BACK TO THE CARDIOLOGIST AND HAS NO UPDATE ON THE PATIENT. THE SURGEON HASN'T SEEN THE PATIENT AND HAS NO ADDITIONAL INFORMATION." ATTEMPTS TO OBTAIN ADDITIONAL CLARIFYING INFORMATION WERE UNSUCCESSFUL.

  Patient problems: Embolism; Stroke/CVA

  MAUDE report 6500425 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARD RECEIVED INDICATE THAT PATIENT RECEIVED ONXACE-25 ON (B)(6) 2015 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2016 AND REPLACEMENT WITH AN ONXAAP-25 INDICATED FOR "ENLARGED ANEURYSM OF ASCENDING AORTA."

  Patient problems: No Code Available

  MAUDE report 5995392 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARDS RECEIVED INDICATED THAT PATIENT RECEIVED ONXACE-25 ON (B)(6) 2013 WHICH REQUIRED INTERVENTION/EXPLANT SOMETIME IN 2016 AND REPLACEMENT WITH ANOTHER ONXACE-25 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

  Patient problems: No Information

  MAUDE report 5995240 ↗
• InjuryOct 3, 2016Contamination; Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARDS RECEIVED INDICATE THAT PATIENT IMPLANTED WITH ONXACE-25 (4824304, VALVE 1) ON (B)(6) 2015 INDICATED FOR AORTIC VALVE REGURGITATION AND BACTERIAL ENDOCARDITIS. RE-INTERVENTION AND EXPLANT REQUIRED ON (B)(6) 2015 FOR BACTERIAL ENDOCARDITIS, REPLACED WITH ONXACE-23 (4945312, VALVE 2). ADDITIONAL RE-INTERVENTION/EXPLANT REQUIRED ON (B)(6) 2015 INDICATED FOR "4+ AORTIC INSUFFICIENCY WITH A ROCKING AORTIC VALVE SUGGESTING DEHISCENCE" AND REPLACED WITH ONXACE-23 (3926503). THIS REPORT IS RELEGATED TO VALVE 1.

  Patient problems: Endocarditis

  MAUDE report 5995201 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARDS RECEIVED INDICATED THAT PATIENT RECEIVED ONXACE-25 SOMETIME IN 2015 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2016 AND REPLACEMENT WITH AN ONXACE-27/29 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

  Patient problems: No Information

  MAUDE report 5995188 ↗
• InjuryMar 22, 2016Perivalvular Leak; Perivalvular Leak

  WHILE ENTERING TRACKING SYSTEM DATA, AN EXPLANT REPORT WAS ENCOUNTERED. REASON FOR EXPLANT WAS RESEARCHED AND FOUND TO BE DUE TO PARAVALVULAR LEAK (PVL), 2 YEARS POST-OP. RE-OPERATED AND REPLACED WITH A TISSUE VALVE. MINIMALLY INVASIVE SURGICAL TECHNIQUE WAS USED. PATIENT PRESENTED AT HOSPITAL WITH PROGRESSIVE WORSENING SHORTNESS OF BREATH, CHEST PAIN. AORTIC INSUFFICIENCY. THIS IS AORTIC VALVE REPLACEMENT (AVR) #3 FOR THIS PATIENT. FIRST VALVE WAS TISSUE IN 2008, 2ND WAS ON-X IN 2013, LATEST RE-DO WAS ANOTHER TISSUE VALVE. 1ST AVR FAILED DUE TO ENDOCARDITIS. RECEIVED EXTENSIVE MEDICAL RECORDS AND OP NOTES FOR THIS PATIENT THIS IS BEING REPORTED BECAUSE PVL IS DEFINED IN THE AATS/STS GUIDELINES AS VALVE-RELATED AND REPORTABLE. IT IS LISTED AMONG THE ADVERSE EVENTS THAT CAN OCCUR FOR A HEART VALVE PATIENT, IN SECTION 5 OF THE IFU. THIS EVENT IS OCCURING WITHIN EXPECTED FREQUENCY AND NO TRENDS ARE SEEN.

  Patient problems: Aortic Insufficiency

  MAUDE report 5516084 ↗
• InjuryFeb 29, 2016Device Operational Issue; Device Operational Issue

  PER OPERATIVE NOTES OBTAINED FROM THE HOSPITAL, THE PATIENT WAS RE-OPERATED, REVEALING A LEAFLET IN HIS ON-X PROSTHETIC AORTIC VALVE WAS COMPLETELY EMBEDDED IN A MIXTURE OF FRESH AND OLD THROMBUS. THE OTHER LEAFLET WAS ALSO IMMOBILE. THE MECHANICAL VALVE WAS EXPLANTED AND A TISSUE VALVE WAS IMPLANTED IN ITS PLACE. THE PATIENT WAS KNOWN TO BE MISSING SOME OF HIS INR MANAGEMENT APPOINTMENTS. ON ADMISSION, HIS INR WAS SUBTHERAPEUTIC. THE PATIENT DID WELL, TRANSFERRED TO ICU IN STABLE CONDITION. DISCHARGED HOME ON POST-OP DAY #4. REASON FOR REPORTING: VALVE THROMBOSIS IS AN EXPECTED ADVERSE EVENT, LISTED IN THE IFU SECTION 5. PER AATS/STS GUIDELINES, VALVE THROMBOSIS IS DEFINED AS VALVE-RELATED AND REPORTABLE. THIS EVENT OCCURS WELL WITHIN EXPECTED FREQUENCY AND THERE IS NO TREND OBSERVED.

  Patient problems: Aortic Insufficiency; Thrombosis

  MAUDE report 5466125 ↗
• InjuryFeb 17, 2016Insufficient Device Problem Information

  PATIENT REPORTED TO ON-X ON (B)(6) 2016, THAT 11 DAYS POST-OPERATIVELY HE HAD TO RETURN TO THE HOSPITAL WITH AN INR OF 6.8 AND THAT HIS PERICARDIAL SAC HAD FILLED WITH OVER A LITER OF BLOOD. DUE TO HIS CONDITION MEDICAL STAFF DID AN EMERGENCY REMOVAL OF BLOOD WITH A NEEDLE THROUGH THE CHEST, WITH NO TIME FOR ANESTHESIA. THE SAC WAS THEN EMPTIED. THE VALVE REMAINS IMPLANTED. THIS IS BEING REPORTED BECAUSE IT IS A BLEEDING EVENT, WHICH IS DEFINED IN THE AATS/STS GUIDELINES AS VALVE-RELATED, AND THAT THE BLEEDING EVENT REQUIRED IMMEDIATE MEDICAL INTERVENTION TO PREVENT PERMANENT INJURY. THUS, THIS IS BEING TREATED AS REPORTABLE. THERE IS NO FURTHER INFORMATION ON WHY HIS ANTICOAGULATION WAS SO FAR OUT OF RANGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Test Result

  MAUDE report 5442537 ↗

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