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

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00851788001464), received between Jan 14, 2016 and Feb 11, 2026 — classified as 2 deaths, 23 injuries, 3 malfunctions.

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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT PRESENTED WITH PANNUS ON HIS ON-X VALVE THAT NEEDED TO BE EXPLANTED AND REPLACED.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 24315165 ↗
• InjurySep 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INTIAL REPORT RECEIVED VIA EMAIL, AN IMPLANT REGISTRATION CARD WAS RECEIVED INDICATING THE PATIENT HAD A SECOND AORTIC IMPLANT. THIS INVESTIGATION IS RELEGATED TO ONXACE-23 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF EXPLANT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 23056988 ↗
• InjuryJun 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT, THE PATIENT'S PRE-OP DIAGNOSIS WAS NSTEMI (NON-ST-ELEVATION MYOCARDIAL INFARCTION), CHEST PAIN. THE DEVICE WAS EXPLANTED DUE TO ENDOCARDITIS WITH LARGE ANNULAR ABSCESS.

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 22125051 ↗
• InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION ON (B)(6) 2025, "MALE PATIENT. TRIFECTA EXPLANTED, ONXACE23 IMPLANTED. A PLEDGIT DROPPED INTO THE LEFT VENTRICLE. THEY USED A LONG TONSIL CLAMP TO GO THROUGH THE ONX VALVE TO GET THE PLEDGIT, ONE OF THE LEAFLETS SHATTERED INTO 3 PIECES AND FELL INTO THE VENTRICLE. IT TOOK ABOUT THREE EXTRA HOURS TO RECOVER THE PIECES. THEY USED FLOURO AND CT TO MAKE SURE THEY HAD ALL THE PIECES. THE PATIENT ENDED UP ON ECHO FOR PULMONARY EDEMA THAT WAS WORSE, SURGEON BELIEVED, BECAUSE OF THE LONG PUMP RUN. TODAY 5/7 THE PATIENT STILL ON ECMO. THE PATIENT DID HAVE MILD PULMONARY EDEMA BEFORE THE CASE." THIS INVESTIGATION IS RELEGATED TO ONXACE-23, SN (B)(6) WITH THE ALLEGATION OF LEAFLET FRACTURE. ADDITIONAL INFORMATION RECEIVED 05/12/2025 FROM SURGEON: "THANKS FOR BRINGING THIS TO THE ATTENTION OF YOUR QI TEAM. THE REPORT MISTAKENLY SAYS THE PATIENT IS ON ECHO INSTEAD OF ECMO. THE PATIENT IS NOT DOING GREAT ¿ STILL ON ECMO OVER A WEEK LATER WITH ONGOING RV FAILURE, RESPIRATORY FAILURE. I WILL TRY TO OBTAIN A COPY OF THE RECORDS FOR YOU."

  Patient problems: Pulmonary Edema; Respiratory Failure

  MAUDE report 22060005 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT IN THE AORTIC PAS STUDY EXPERIENCED A THROMBOEMBOLISM.

  Patient problems: Stroke/CVA; Thromboembolism

  MAUDE report 21583008 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, CASE WAS ON (B)(6)2024 AND WAS UNEVENTFUL. I WAS NOT IN ATTENDANCE. TODAY, WHILE EXPLANTING THE VALVE, THE SURGEON DID SAY SHE NOTICED AT THE TIME OF THE INITIAL SURGERY, ONE OF THE LEAFLETS WAS NOT OPENING AND CLOSING FREELY. TO MY KNOWLEDGE, IT¿S UNKNOWN WHAT ADJUSTMENTS WERE MADE TO ENSURE LEAFLETS MOVED FREELY. PATIENT SUBSEQUENTLY REPORTED SUFFERING FROM BREATHING RELATED DIFFICULTIES. THE ONX WAS EXPLANTED AND A ST. JUDE VALVE WAS IMPLANTED. I AM HOPING TO SPEND SOME TIME WITH THE SURGEON TO GATHER ADDITIONAL DETAILS. PER THE HOSPITAL STAFF IT SOUNDS LIKE THE SURGEON SHOULD/COULD HAVE REMOVED SOME TISSUE THAT WAS IN THE WAY OF THE LEAFLET AND PREVENTED IT FROM MOVING. THIS INVESTIGATION IS RELEGATED TO ONXACE-23 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF EXPLANT DUE TO LEAFLETS NOT OPENING AND CLOSING FREELY.

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

  MAUDE report 21173369 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "RECEIVED AN AORTIC IMPLANT REGISTRATION CARD FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT." IMPLANT DATE (B)(6) 2022. EXPLANT DATE (B)(6) 2024.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20570479 ↗
• InjuryOct 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN IMPLANT REGISTRATION CARD WAS RECEIVED FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT, INDICATING EXPLANT OF THE ORIGINAL IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 20400254 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORT, PATIENT WAS SEEN AS AN OUTPATIENT ON (B)(6) 2023 FOR THROMBOEMBOLISM, SPECIFICALLY AN OCCLUSION OF THE LEFT INTERNAL CAROTID ARTERY. PATIENT WAS NOT HOSPITALIZED AND THERE IS NO EVIDENCE THAT AN ECHO WAS PERFORMED.

  Patient problems: Thromboembolism

  MAUDE report 19951598 ↗
• DeathJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN IMPLANT REGISTRATION CARD WAS RECEIVED WHICH HAD WRITTEN ON IT, ¿PATIENT DECEASED.¿ OBITUARY CONFIRMED DEATH DATE OF (B)(6) 2024.

  Patient problems: Insufficient Information; Myocardial Infarction

  MAUDE report 19752555 ↗
• InjuryJan 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION RECEIVED VIA EMAIL ON (B)(6) 2024, ONXACE-23 WAS EXPLANTED ON (B)(6) 2023*. RECEIPT OF ADDITIONAL INFORMATION FROM THE SURGEON: THE ON-X EXPLANT WAS FOR INFECTION UNRELATED TO THE VALVE. INFORMATION FROM THE OPERATIVE NOTES: IMPLANT OF ON-X ACE 23 PERFORMED ON (B)(6) 2021 DUE TO PROSTHETIC VALVE STENOSIS AND INSUFFICIENCY. THE ON-X ACE 23 WAS EXPLANTED ON (B)(6) 2023 DUE TO AORTIC VALVE DEHISCENCE. SUSPECTED ENDOCARDITIS, AND ALL CULTURES HAVE BEEN NEGATIVE. SEE ATTACHMENT TITLED: OPERATIVE NOTES FOR DETAILS. THE EXPLANT DATE WAS REPORTED IN ERROR. THE CORRECT EXPLANT DATE IS ON (B)(6) 2023. NO ADDITIONAL INFORMATION FORTHCOMING. THIS EVENT IS RELEGATED TO ONXACE-23 SERIAL NUMBER: (B)(6) .

  Patient problems: Endocarditis; Stenosis

  MAUDE report 18608038 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, A 62-YEAR OLD PATIENT WHO RECEIVED ONXACE-23, SN (B)(6) ON (B)(6) 2023 HAD A PARAVALVULAR LEAK NOTED ON TEE. PATIENT WAS REOPENED AND PLEDGETED SUTURES WERE INSERTED AT THE SITE OF LEAK. TEE ON (B)(6) 2023 SHOWED REDUCTION IN THE LEAK. FLUOROSCOPY WAS PERFORMED AND ONLY ONE VALVE LEAFLET COULD BE OBSERVED MOVING. REOPERATION WAS PERFORMED AND VALVE LEAFLETS WERE OBSERVED TO BE FUNCTIONING PERFECTLY. VALVE WAS REMOVED AND REPLACED WITH A NON-ARTIVION VALVE TO RESOLVE THE PVL. THE SENIOR SURGEON COMMENTED, ¿VALVE WAS PERFECT, HIGH GRADIENT COULD HAVE BEEN RESULT OF INACCURATE ECHO MEASUREMENTS.¿

  Patient problems: Insufficient Information; Valvular Insufficiency/ Regurgitation

  MAUDE report 17406997 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON (B)(6) 2022 FROM CLINICAL RESEARCH, "PATIENT IS SUBJECT #243 IN THE ON-X POST APPROVAL STUDY. THE PATIENT HAD AN EPISODE OF SUDDEN BLINDNESS IN RIGHT EYE LASTING 1 MINUTE ON (B)(6) 2022. THE PATIENT DID NOT SEEK MEDICAL ATTENTION AT THE TIME. AFTER THE RESEARCH FOLLOW-UP ON (B)(6) 2022, THE PATIENT ATTENDED A&E WHERE RETINAL TIA WAS SUSPECTED, AND THE PATIENT WAS REFERRED TO TIA CLINIC. CT NORMAL. FULLY RESOLVED. NO TREATMENT REQUIRED. ADJUDICATION OF THIS EVENT DETERMINED IT TO BE POSSIBLY VALVE-RELATED. THIS INVESTIGATION WILL BE RELEGATED TO ONXACE-23, SN (B)(4).

  Patient problems: Transient Ischemic Attack

  MAUDE report 15788846 ↗
• DeathJul 8, 2022Adverse 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 RECEIVED, AN IMPLANT REGISTRATION CARD WAS RECEIVED WITH A HAND-WRITTEN NOTE: "EXPIRED @ 1607 (B)(6) 2022." PATIENT'S OBITUARY WAS FOUND. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED TO DATE.

  Patient problems: Insufficient Information

  MAUDE report 14955193 ↗
• InjuryMar 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT EXPERIENCED A MAJOR PERIPHERAL THROMBOEMBOLISM.

  Patient problems: Thromboembolism

  MAUDE report 13694815 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA A PHONE CONVERSATION ON (B)(6) 2022 WITH CRYOLIFE SALES REPRESENTATIVE (CSR), ONE OF MY SURGEONS JUST CALLED TO REPORT THAT A PATIENT OF HIS HAS BEEN ADMITTED TODAY [(B)(6) 2022] FOR A STROKE. THE PATIENT HAD AN ONX AORTIC VALVE IMPLANTED POSSIBLY IN (B)(6) 2021. PER THE SURGEON THE "PATIENT IS DOING OK."

  Patient problems: Stroke/CVA

  MAUDE report 13235449 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL REPORTS, "PATIENT WITH ONXACE-23 SN (B)(4) IMPLANTED (B)(6) 2016. THE PATIENT IS HEALTHY. WHILE PLAYING WITH CHILDREN IN THE YARD THE PATIENT EXPERIENCED A TIA EVENT AND DOUBLE VISION. PATIENT WAS RUNNING AT AN INR CLOSE TO 1.5 BUT THE DOCTOR BROUGHT IT UP AS A PRE-CAUTION. THIS INVESTIGATION IS RELEGATED TO ONXACE-23 SN (B)(4).

  Patient problems: Transient Ischemic Attack

  MAUDE report 11895855 ↗
• InjuryJun 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON-X AORTIC PROSTHETIC HEART VALVE LOW DOSE WARFARIN POST APPROVAL CLINICAL REGISTRY STUDY, IMPLANTED (B)(6) 2017, EVENT DATE (B)(6) 2018: PRESENTED WITH CHEST PAIN, SOB AND PYREXIA. SPUTUM CULTURE CONFIRMED KLEBSIELLA PNEUMONIA ESBL+. EVENT DATE (B)(6) 2018: ADMITTED WITH SHORTNESS OF BREATH AND TREATED AS INFECTIVE EXACERBATED COPD. EVENT DATE (B)(6) 2018: PRESENTED TO ED [EMERGENCY DEPARTMENT] WITH VOMITING, CHEST PAIN, FAST HEART RATE AND HIGH BLOOD PRESSURE. INR FOUND TO BE 4.8, WARFARIN HELD. BP CONTROLLED WITH AMLODIPINE. NO MORE CHEST PAIN. EVENT DATE (B)(6) 2018: ADMITTED WITH SOB. GANGRENOUS TOES ON RIGHT FOOT (2ND & 3RD), DUE TO AMPUTATION OF TOES. TOES AMPUTATED (B)(6) 2018. NOT HEALING WELL. STILL IN HOSPITAL (B)(6) 2018, FOR BELOW KNEE AMPUTATION. NOTE FROM CLINICAL TRIAL ADJUDICATOR, DR. (B)(6), STATES "THIS PATIENT HAS HAD A NUMBER OF HOSPITAL ER VISITS PRIMARILY FOR PULMONARY ISSUES SECONDARY TO COPD AND KLEBSIELLA PNEUMONIA, BUT AT NO TIME WAS THERE A NOTE ABOUT IMPAIRED LE CIRCULATION WHICH COULD BE RESPONSIBLE FOR THE RLE GANGRENE AND ULTIMATE NEED FOR A BK AMPUTATION. THEREFORE ONE HAS TO QUESTION THE POTENTIAL FOR EMBOLIZATION AS THE CAUSE FOR THE SUDDEN DEVEL

  Patient problems: Chest Pain; Chronic Obstructive Pulmonary Disease (COPD); Gangrene; High Blood Pressure/ Hypertension; Pneumonia

  MAUDE report 7613026 ↗
• InjuryMay 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ONXACE-23 SN (B)(4) WAS IMPLANTED ON (B)(6)2017 AND EXPLANTED ON (B)(6)2018. ACCORDING TO OPERATIVE NOTES RECEIVED, "HE DID WELL INITIALLY; HOWEVER, HE RETURNED WITH CONGESTIVE HEART FAILURE TYPE SYMPTOMS AND WAS IDENTIFIED AS HAVING SEVERE PERIVALVULAR LEAK AROUND HIS VALVE. HE WAS ALSO NOTED TO HAVE AN AORTIC ROOT DILATION WITH CONTINUED DISSECTION THROUGHOUT HIS AORTA."

  Patient problems: Aortic Dissection; Aortic Regurgitation

  MAUDE report 7519343 ↗
• InjuryDec 12, 2017Perivalvular Leak; Perivalvular Leak

  ACCORDING TO THE INFORMATION RECEIVED, A (B)(6) FEMALE RECEIVED AN ONXACE-23 (B)(4) ON (B)(6) 2017 AND REQUIRED RE-INTERVENTION/EXPLANT ON (B)(6) 2017 DUE TO SEVERE LARGE PARAVALVULAR LEAK. IT WAS REPLACED WITH ANOTHER ONXACE-23 VALVE.

  Patient problems: Pseudoaneurysm

  MAUDE report 7109971 ↗
• InjuryOct 14, 2016Insufficient Device Problem Information; Insufficient Device Problem Information

  IMPLANT RECOVERY CARD RECEIVED INDICATED THAT (B)(6) MALE RECEIVED ONXACE-23 (SN (B)(4)) ON (B)(6) 2014 AND REQUIRED EXPLANT ON (B)(6) 2016 AND SUBSEQUENT REPLACEMENT WITH ANOTHER ONXACE-23.

  Patient problems: No Code Available

  MAUDE report 6029694 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARDS RECEIVED INDICATE THAT PATIENT IMPLANTED WITH ONXACE-25 ((B)(4), 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 ((B)(4), 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 ((B)(4)). THIS REPORT IS RELEGATED TO VALVE 2.

  Patient problems: Aortic Insufficiency; Organ Dehiscence

  MAUDE report 5995206 ↗
• MalfunctionMay 23, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AFTER IMPLANT OF THE PROSTHETIC AORTIC VALVE, AND AFTER THE PATIENT WAS TAKE OFF THE BYPASS, TRANSESOPHOGEAL ECHO (TEE) WAS USED TO VERIFY PROPER FUNCTION OF THE VALVE. A LARGE PRESSURE GRADIENT WAS OBSERVED ALONG WITH OBSERVING THAT A LEAFLET WAS NOT MOVING PROPERLY. THE ON-X VALVE WAS EXPLANTED AND REPLACED TO COMPLETE SURGERY. THE ON-X VALVE WAS RETURNED FOR PRODUCT EVALUATION.

  Patient problems: No Code Available

  MAUDE report 5673823 ↗
• MalfunctionApr 29, 2016Mechanical Problem; Mechanical Problem

  AFTER IMPLANT OF THE PROSTHETIC AORTIC VALVE, AND AFTER PATIENT WAS TAKEN OFF THE BYPASS, TRANSESOPHAGEAL ECHO (TEE) WAS USED TO VERIFY PROPER FUNCTION OF THE VALVE. A LARGE PRESSURE GRADIENT WAS OBSERVED ALONG WITH OBSERVING THAT A LEAFLET WAS NOT MOVING PROPERLY. THE ON-X VALVE WAS EXPLANTED AND REPLACED TO COMPLETE THE SURGERY. THE ON-X VALVE WAS RETURNED FOR PRODUCT EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5621294 ↗
• InjuryApr 28, 2016Adverse Event Without Identified Device or Use Problem

  WHILE ENTERING TRACKING DATABASE IMPLANT INFORMATION, A PATIENT WAS OBSERVED TO HAVE RECEIVED A SECOND IMPLANT OF THE SAME POSITION (AORTIC). THE SURGEON'S OFFICE WAS CONTACTED AND IT WAS REPORTED THAT THE RE-OPERATION WAS DUE TO PROSTHETIC ENDOCARDITIS. NO OTHER INFORMATION AVAILABLE. VALVE IS NOT AVAILABLE FOR RETURN. THIS IS BEING REPORTED BECAUSE ENDOCARDITIS IS DEFINED IN THE AATS/STS GUIDELINES AS VALVE-RELATED AND REPORTABLE, THEREFORE IT IS BEING REPORTED. IT IS LISTED AMONG EXPECTED ADVERSE EVENTS THAT CAN OCCUR FOR A HEART VALVE PATIENT IN SECTION 5 OF THE IFU. IT IS OCCURRING WITHIN EXPECTED FREQUENCY, NO TRENDS ARE SEEN.

  Patient problems: Endocarditis

  MAUDE report 5614631 ↗

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