On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder ONXACE-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00851788001457), received between Feb 9, 2016 and Sep 15, 2025 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2025Adverse 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) FOR AN AORTIC ON-X WAS RECEIVED FOR A PATIENT WITH AN EXISTING AORTIC ON-X IMPLANT, INDICATING THE ORIGINAL IMPLANT WAS EXPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 23057203 ↗
• InjuryJul 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO INITIAL REPORTS, "PATIENT IS IN THE ON-X PAS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN EVENT ON (B)(6) 2022. THE EVENT WAS DESCRIBED AS THROMBOEMBOLISM: ¿ACUTE CVA, DYSPHASIA¿, THE EVENT DURATION WAS 3 DAYS AND WAS FULLY RESOLVED. THIS EVENT IS RELEGATED TO ONXACE-21 (B)(6) FOR THROMBOEMBOLISM. ADJUDICATION RECEIVED STATING THE EVENT IS RELATED TO THE DEVICE. ADDITIONAL INFORMATION RECEIVED. 62-YEAR-OLD MALE WITH PAST MEDICAL HISTORY SIGNIFICANT FOR MECHANICAL AORTIC VALVE REPLACEMENT, HISTORY OF CAD, HISTORY OF ESSENTIAL HYPERTENSION, HYPERLIPIDEMIA, RECENT LEFT MCA TERRITORY ISCHEMIC CVA (NEUROLOGY SUSPECTED THIS TO BE SECONDARY TO LARGE VESSEL ATHEROSCLEROTIC DISEASE OF THE LEFT INTERNAL CAROTID ARTERY, ADMITTED FROM (B)(6) 2022), HISTORY OF MIGRAINE PRESENTED TO THE ED WITH CHIEF COMPLAINTS OF LEFT-SIDED HEADACHE, BLURRED VISION SINCE YESTERDAY MORNING ALONG WITH WORSENING SPEECH. ELEVATION IN THE ER WITH CTA HEAD AND NECK SHOWED NEW EVOLVING RIGHT INFERIOR OCCIPITAL PCA TERRITORY INFARCT THAT SPANS APPROXIMATELY 5 CM WITHOUT HEMORRHAGE ALONG WITH KNOWN EVOLVING SMALL TO MODERATE SIZE LEFT POSTERIOR MCA LATE SUBACUTE INFARCT. INR THERAPEUTIC TODAY AT 2.0, AT

  Patient problems: Thromboembolism

  MAUDE report 22386414 ↗
• InjuryNov 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION, "RECEIVED AN AORTIC IRC FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT. PLEASE LET ME KNOW IF THIS IS AN EXPLANT." THIS INVESTIGATION IS RELEGATED TO ONXACE-21, SN (B)(6) WITH THE ALLEGATION OF EXPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 20620861 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL REPORTS, AN EVENT FOR PATIENT IN THE ON-X POST APPROVAL STUDY WAS REPORTED 31JUL2024. THE EVENT IS REPORTED AS PROSTHETIC ENDOCARDITIS WITH STREPTOCOCCUS GALLOLYTICUS AND IS FULLY RESOLVED AFTER 18 DAYS. INR WAS 2.3 ON (B)(6) 2024. EVENT WAS ADJUDICATED AS PROSTHETIC ENDOCARDITIS AND VALVE RELATED."

  Patient problems: Endocarditis

  MAUDE report 20039770 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INTIAL REPORT A PATIENT HAD AN ONXACE-21, SERIAL NUMBER: (B)(6), IMPLANTED ON (B)(6) 2022. AN IMPLANT REGISTRATION CARD (IRC) WAS RECEIVED ON 16APRIL2024 AT ARTIVION, INC. THE IRC INDICATED THAT THE ONXACE-21 WAS EXPLANTED ON (B)(6) 2024. THE REASON FOR EXPLANT IS UNKNOWN.

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

  MAUDE report 19280123 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION, PATIENT IS SUBJECT IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY. THE PATIENT WAS IMPLANTED WITH A SURGEON MADE AAP DEVICE AND ON-X AORTIC VALVE SN# (B)(6) ON (B)(6) 2011. ON (B)(6) 2011 (217 DAYS POST IMPLANT) THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A DIAGNOSIS OF TIA. PATIENTS INR WAS 1.6 AT THE TIME OF THE EVENT. PER MEDICAL RECORDS PROVIDED ¿PATIENT WAS ADMITTED WITH TIA SYMPTOMS. I NR WAS SUBTHERAPEUTIC. LOVENOX INITIATED AND COUMADIN DOSE WAS INCREASED. CT BRAIN NEGATIVE. TEE DONE TO ASSESS PROSTHETIC VALVE WITHOUT EVIDENCE OF ANY ASSOCIATED THROMBUS. NEUROLOGY WAS CONSULTED AND FELT.LIKELY A TIA (IF RECURRENCE OF SX'S WHILE THERAPEUTIC WOULD CONSIDER CAROTID U/S). PATIENT ALSO FOUND TO HAVE TRIGLYCERIDES OF 470 AND HDL OF 26 AND WAS STARTED ON CRESTOR 10MG AND 2G FISH OIL. THE PATIENT WILL GO HOME WITH LOVENOX AND INCREASED COUMADIN.¿ PATIENT WAS DISCHARGED HOME ON (B)(6) 2011 WITH RECOMMENDATION OF FOLLOW UP IN 4 WEEKS.

  Patient problems: Transient Ischemic Attack

  MAUDE report 18594556 ↗
• InjuryDec 4, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 02OCT2023, "THIS IS SUBJECT 331 FROM THE ON-X AORTIC POST-APPROVAL STUDY. THE SUBJECT WAS HOSPITALIZED DUE TO VALVE THROMBOSIS." THE MEDICAL RECORD RECEIVED RELAYED THAT A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED. THE REPORT STATED "MECHANICAL AVR IN SITU APPEARS WELL-SEATED, NO OBVIOUS SIGNS OF DEHISCENCE. NO OBVIOUS MOBILE STRUCTURES SEE ATTACHED TO THE PROSTHETIC VALVE." BASED ON THE ADJUDICATION FORM COMPLETED THIS EVENT IS UNRELATED TO THE VALVE. ADDITIONAL INFORMATION RECEIVED FROM ARTIVION CLINICAL TRIAL MANAGER, "THIS EVENT FOR 331 WAS LOOKED INTO FURTHER AND WAS RECLASSIFIED AS VALVE THROMBOSIS." NO ADDITIONAL INFORMATION FORTHCOMING. THIS INVESTIGATION IS RELEGATED TO ONXACE-21, SERIAL NUMBER: (B)(6).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18256038 ↗
• InjuryAug 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT AN AORTIC IMPLANT REGISTRATION CARD WAS RECEIVED FOR A ONXACE-21 THAT IS FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT. THE ONXACE-21 SN: (B)(6) WAS IMPLANTED ON (B)(6) 2023. IT WAS THEN EXPLANTED ON (B)(6) 2023. ADDITIONAL INFORMATION PROVIDED FROM THE SURGEON IS AS FOLLOWS "I EXPLANTED THE VALVE SO I COULD DO A REDO AVR/MVR FOR MITRAL VALVE ENDOCARDITIS (CULTURE NEGATIVE). I PUT ANOTHER ON-X BACK IN THE AORTIC POSITION AND PUT AN ON-X MECHANICAL IN THE MITRAL. THE OLD DEHISCED VALVE WAS A ST. JUDE. THERE WAS NOTHING WRONG WITH THE ON-X AORTIC VALVE. I JUST TOOK IT OUT FOR EXPOSURE PURPOSES AND I COULD NOT SAY THAT IT WAS NOT INFECTED. IT LOOKED PERFECT AND IT WAS FUNCTIONING PERFECTLY TOO. VALVE WAS NOT SAVED. PATIENT IS DOING GREAT." NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Endocarditis

  MAUDE report 17558987 ↗
• InjuryMar 15, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  ACCORDING TO THE INITIAL REPORT RECEIVED, ¿I WILL MEET THE SURGEON TODAY AND I WILL BRING THE VALVE AND SEND TO YOU FOR INSPECTION. BUT UNFORTUNATELY THE PATIENT IN BAD CASE AT CCU I GOT MESSAGE FROM UNIVERSITY HOSPITAL THAT THEY HAVE CASE USED ONXACE - 21 BUT THE VALVE IS NOT WORK THEY ENTER THE PATIENT TO OR AND REPLACE THE VALVE, BUT WHEN THEY CHECK LEAFLET IS WORKING, BUT INSIDE PATIENT WASN'T WORK ECO IS AVAILABLE SURGEON ASKED ME IF IT REPORTED BEFORE HERE IN KSA OR ANY OTHER COUNTERY? I SAID IT'S FIRST TIME TO HEAR ABOUT THAT AND NEVER REPORTED IN KSA BEFORE¿ ADDITIONAL INFORMATION WAS RECEIVED FROM THE SURGEON, "I¿M WRITING THIS EMAIL WITH REGARDS TO THE ON X VALVE THAT WAS UNEXPECTEDLY MALFUNCTIONING POST IMPLANTATION. FOLLOWING ARE THE CASE DETAILS: 42 YEAR OLD FEMALE WITH HISTORY OF SYSTEMIC LUPUS ERYTHEMATOSUS AND CHRONIC KIDNEY DISEASE. SHE WAS ADMITTED WITH HEART FAILURE AND FOUND TO HAVE SEVERE AORTIC INSUFFICIENCY. SHE WAS TAKEN TO THE OR ON (B)(6) 2023. THE PATIENT HAD ISSUES WITH DYSPHAGIA AND WAS DEEMED TO HAVE A CONTRAINDICATION TO TEE AND WAS THEREFORE THIS WAS NOT DONE INTRAOP. OPERATIVE FINDINGS SHOWED A LEFT CORONARY CUSP THAT WAS THICKENED AND RETRACTED, TH

  Patient problems: Aortic Valve Stenosis

  MAUDE report 16547062 ↗
• InjuryFeb 8, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE INITIAL REPORT THROUGH THE LIVE REGISTRY, THE ON-X LOW DOSE POST APPROVAL REGISTRY PATIENT (252) WAS HOSPITALIZED FOR A HEART ATTACK ON (B)(6) 2022. THE PATIENT WAS ALSO NOTED TO HAVE CONGESTIVE HEART FAILURE, ATRIAL FIBRILLATION, HYPONATREMIA (LOW LEVEL OF SODIUM IN THE BLOOD), AND EPISTAXIS (NOSEBLEED). THE EVENT FULLY RESOLVED AFTER 10 DAYS. ON (B)(6) 2018 ONXACE-21 SN (B)(6) WAS IMPLANTED IN THE AORTIC POSITION IN A 70-YEAR-OLD FEMALE PATIENT WHO WAS SUBSEQUENTLY ENROLLED IN THE ON-X LOW DOSE POST APPROVAL STUDY (PAS) AS SUBJECT # 252. TWO EVENTS WERE REPORTED TO THE MANUFACTURER; THE FIRST EVENT WAS A MYOCARDIAL INFARCTION WITH ANGIOPLASTY AND THE SECOND EVENT WAS AN EPISODE OF SEVERE EPISTAXIS AS A RESULT OF A SUPRATHERAPEUTIC INR RESULTING IN A HOSPITAL ADMISSION. UPON REVIEW OF THE PATIENT¿S MEDICAL RECORD, IT WAS DETERMINED THAT THE MYOCARDIAL INFARCTION WITH ANGIOPLASTY OCCURRED ON (B)(6) 2022. THE SECOND EVENT OF SEVERE EPISTAXIS AS A RESULT OF A SUPRATHERAPEUTIC INR RESULTED IN A HOSPITAL ADMISSION THAT OCCURRED ON (B)(6) 2022. ADDITIONALLY, A COMPLICATION ADJUDICATION WAS SUBMITTED BY SIDNEY LEVITSKY, MD FOR THE MYOCARDIAL INFARCTION WITH ANGIOPLASTY A

  Patient problems: Epistaxis; Heart Failure/Congestive Heart Failure; Myocardial Infarction

  MAUDE report 16326384 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, "ANOTHER AORTIC IMPLANT FOUND FOR SAME PATIENT. NEW IMPLANT SN (B)(4) ONXACE 23".

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

  MAUDE report 14745069 ↗
• InjuryDec 28, 2021Material Integrity Problem; Material Integrity Problem

  ACCORDING TO INITIAL REPORTS, "MATERIAL DETACHED FROM THE FRAME OF AN ON-X AORTIC VALVE, ALTHOUGH NO GREAT FORCE WAS APPLIED" SURGERY PROLONGED. THIS INVESTIGATION IS RELEGATED TO ONXACE-21 (B)(4).

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

  MAUDE report 13095023 ↗
• InjuryNov 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "PATIENT IS SUBJECT (B)(6) IN THE (B)(6) POST APPROVAL STUDY. NEUROLOGIC THROMBOEMBOLISM, SUBACUTE INFARCTION WAS REPORTED TO HAVE LASTED 3 DAYS AND FULLY RESOLVED WITH NO TREATMENT." ADJUDICATION DETERMINED THIS EVENT TO BE VALVE-RELATED. THIS INVESTIGATION WILL BE RELEGATED TO ONXACE-21, SN (B)(4).

  Patient problems: Thromboembolism

  MAUDE report 12746829 ↗
• InjuryAug 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "PATIENT EXPERIENCED CHEST PAIN. BROUGHT TO CATH LAB ON (B)(6) 2019. DETERMINED HE HAD INFARCT. THROMBUS DISCOVERED ON VALVE LEAFLET AND CIRCUMFLEX. TERMED AS ORGANIZED CLOT. ONE OF THE TWO LEADFLETS [LEAFLETS] NOT OPENING.TRAETED [TREATED] WITH THROMBOLYTIC THERAPY. ONE LEADFLET [LEAFLET] STILL CLOSED ON (B)(6) 2019. VALVE LEAFLET DETERMINED OPEN ON (B)(6) 2019. PATIENT NOW STABLE."

  Patient problems: Chest Pain; Thrombus

  MAUDE report 8859975 ↗
• InjuryJul 15, 2019Perivalvular Leak; Insufficient Device Problem Information; Perivalvular Leak; Insufficient Device Problem Information

  ACCORDING TO INITIAL REPORTS, THE SURGEON IMPLANTED AN ONXACE-21 SERIAL NUMBER (B)(4) IN A REDO AVR CASE. ON CARDIAC ECHO WHEN THE PATIENT CAME OFF BYPASS A LEAK WAS NOTED THROUGH THE LEAFLETS. SURGEON EXPLANTED IT AND REPLACE IT WITH ANOTHER IDENTICAL ONXACE-21. PERTINENT CO-MORBIDITIES - HEAVILY CALCIFIED ANNULUS.

  Patient problems: Regurgitation

  MAUDE report 8790283 ↗
• InjuryFeb 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT OF THE MCRI ON-X LOW DOSE POST-MARKET REGISTRY DEVELOPED COMPLETE HEART BLOCK POSTOPERATIVELY. PERMANENT PACEMAKER IMPLANTED ON DAY 7.

  Patient problems: Complete Heart Block

  MAUDE report 8339366 ↗
• 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-21 ON (B)(6) 2009 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2015 AND REPLACEMENT WITH AN ONXACE-23 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

  Patient problems: No Information

  MAUDE report 5995380 ↗
• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT WAS IMPLANTED WITH A SIZE 21MM ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER. THE 21MM WAS TOO TIGHT AND WAS CAUSING IMPINGEMENT. THE PATIENT WAS PLACED BACK ON THE PUMP AND WENT INTO HEART BLOCK. A SIZE 19MM ON-X AORTIC HEART VALVE WITH CONFORM-X SEWING RING AND EXTENDED HOLDER WAS IMPLANTED DURING THE SAME PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 5967521 ↗
• InjuryApr 28, 2016Appropriate Device Problem Term/Code Not Available

  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 THE OPERATIVE NOTES WERE OBTAINED, WHICH EXPLAIN WHY THE RE-DO AORTIC VALVE REPLACEMENT (AVR) WAS DONE. THE PATIENT WAS DIAGNOSED WITH PARAVALVULAR LEAK (PVL). PATIENT WAS RE-OPERATED AND A NEW VALVE ONXACE-21, S/N (B)(4) WAS IMPLANTED. THE VALVE BEING EXPLANTED HAD DEHISCED JUST RIGHT OF THE RIGHT CORONARY COMMISURE. INTRAOP TRANSESOHPAGEAL ECHO SHOWED NO PVL POST VALVE REPLACEMENT. PATIENT TRANSFERRED TO ICU HAVING TOLERATED THE RE-OP WELL. THE REASON THIS IS BEING REPORTED IS PVL IS DEFINED IN THE AATS/STS GUIDELINES AS VALVE-RELATED AND REPORTABLE. IT IS ALSO AN EXPECTED ADVERSE EVENT, AND IS LISTED AMONG THE EXPECTED ADVERSE EVENTS POSSIBLE FOR A HEART VALVE PATIENT, IN SECTION 5 OF THE IFU.

  Patient problems: Aortic Insufficiency

  MAUDE report 5617499 ↗
• InjuryMar 1, 2016Perivalvular Leak

  AS PER THE REQUEST SUBMITTED BY FDA MEDWATCH PROGRAM, THIS REPORT IS BEING RESUBMITTED AS REPORT NUMBER 1649833-2016--70010-1. THIS REPORT WAS INITIALLY SUBMITTED AS 1649833-2015-70027 - 1, APRIL 28, 2016. DESCRIPTION FROM ORIGINAL FOLLOW-UP MEDWATCH REPORT AS FOLLOWS: 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 THE OPERATIVE NOTES WERE OBTAINED, WHICH EXPLAIN WHY THE RE-DO AORTIC VALVE REPLACEMENT (AVR) WAS DONE. THE PATIENT WAS DIAGNOSED WITH PARAVALVULAR LEAK (PVL). PATIENT WAS RE-OPERATED AND A NEW VALVE ONXACE-21 S/N (B)(4) WAS IMPLANTED. THE VALVE BEING EXPLANTED HAD DEHISCED JUST RIGHT OF THE RIGHT CORONARY COMMISURE. LNTRAOP TRANSESOPHAGEAL ECHO SHOWED NO PVL POST VALVE REPLACEMENT. PATIENT TRANSFERRED TO ICU HAVING TOLERATED THE RE-OP WELL. THE REASON THIS IS BEING REPORTED IS PVL IS DEFINED IN THE AATS/STS GUIDELINES AS VALVE-RELATED AND REPORTABLE. IT IS ALSO AN EXPECTED ADVERSE EVENT, AND IS LISTED AMONG THE EXPECTED ADVERSE EVENTS POSSIBLE FOR A HEART VALVE PATIENT, IN SECTION 5 OF THE IFU.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 5471831 ↗
• MalfunctionFeb 9, 2016No Apparent Adverse Event; No Apparent Adverse Event

  AS PER THE REQUEST SUBMITTED BY FDA MEDWATCH PROGRAM, THIS REPORT IS BEING RESUBMITTED AS REPORT NUMBER 1649833-2016-70004-1. THIS REPORT PREVIOUSLY WAS SUBMITTED AS 1649833-2015-70025-1, FEBRUARY 9, 2016. DESCRIPTION FROM ORIGINAL FOLLOW-UP MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MDR NO. 1649833-2015-70025-1. EVENT OCCURRED IN (B)(6). ORIGINAL REPORT STATED: "DISTRIBUTOR IN B)(4) NOTIFIED ONXLTI THAT THE SEWING RING STITCHING WAS UNRAVELING. THE CONDITION WAS NOTICED AT THE BEGINNING OF THE SURGERY. THE VALVE WILL BE RETURNED TO ONXLTI FOR INVESTIGATION". THE VALVE HAS BEEN RETURNED AND EVALUATED. THIS VALVE IS VERY SIMILAR TO PAST OCCURRENCES OF THIS TYPE WHICH HAVE BEEN ATTRIBUTED TO IATROGENIC DAMAGE, WHERE THE SURGEON'S NEEDLE PATH WAS TOO CLOSE TO THE VALVE BODY WHERE THE SEWING RING CONSTRUCTION SUTURE IS LOCATED, CUTTING THE CONSTRUCTION SUTURE, AND ALLOWING IT TO UNRAVEL AS FAR AS 4 STITCHES UP TO THE POINT A THE STOP KNOT. UNRAVELING DOES NOT PROGRESS BEYOND THE STOP KNOT, IT IS CONCLUDED THAT THE VALVE DID NOT MALFUNCTION, IT WAS DAMAGED BY USER ERROR. THE IFU IS CLEAR ON INSTRUCTIONS ABOUT NEEDLE PATH IN THE SEWING RING.

  Patient problems: Insufficient Information

  MAUDE report 5420058 ↗

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