On-X Mitral Heart Valve with Standard Sewing RingRecalls & reported problems across all models

We found 3 models of On-X Mitral Heart Valve with Standard Sewing Ring by On-X Life Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Aug 11, 2015 and Nov 24, 2025 — classified as 11 deaths, 23 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported On-X Mitral Heart Valve with Standard Sewing Ring problems

On-X Mitral Heart Valve with Standard Sewing Ring models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• On-X Mitral Heart Valve with Standard Sewing Ring ONXM-25

  Heart-Valve, Mechanical
  6 deaths17 reports
• On-X Mitral Heart Valve with Standard Sewing Ring ONXM-27/29

  Heart-Valve, Mechanical
  3 deaths15 reports
• On-X Mitral Heart Valve with Standard Sewing Ring ONXM-31/33

  Heart-Valve, Mechanical
  2 deaths9 reports

Recent On-X Mitral Heart Valve with Standard Sewing Ring adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT A ON-X MITRAL VALVE WAS EXPLANTED.

  Patient problems: Endocarditis

  MAUDE report 23632400 ↗
• InjurySep 2, 2025Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION, "ON-X AORTIC LEAFLET NOT FUNCTIONING AND QUESTION REGARDING THE SIZER HANDLE." ADDITIONAL INFORMATION RECEIVED 08/11/2025: IS THERE AN ALLEGATION OF DEFICIENCY WITH THE ONX VALVE? ON TEE POST OP IT APPEARED ONE OF THE LEAFLETS WAS WIDE OPEN HAS ANY ADDITIONAL IMAGING BEEN PERFORMED POST OPERATIVELY THAT SHOWS THE LEAFLET IS MOVING AS INTENDED? CAN THAT BE SHARED? UNSURE AS THE PATIENT THEN HAD A TAVR WHEN IN CATH LAB PLEASE PROVIDE A BRIEF MEDICAL/SURGICAL HISTORY OF THE PATIENT. ON (B)(6) PATIENT ARRIVED FOR A MAZE AND AORTIC VALVE PROCEDURE WHICH WAS COMPLETED. UNABLE TO WEAN PATIENT FROM PUMP AND LEFT VENTRICLE WAS NOT MOVING. PATIENT THEN HAD A LIMA TO LAD AND AN SVG TO THE OM. STILL UNABLE TO WEAN FROM PUMP AND LEFT VENTRICLE STILL WAS NOT FUNCTIONING. PATIENT TAKEN TO CATH LAB AND PLACED ON ECMO. THIS IS WHEN IT WAS DISCOVERED THE LEAFLET WAS NOT FUNCTIONING PROPERLY. AT THIS TIME, A TAVR WAS PERFORMED. PATIENT RETURNED TO SURGERY AGAIN THAT (B)(6) TWICE AND THEN AGAIN ON (B)(6). PATIENT REMOVED FROM ECMO (B)(6). HOW IS THE PATIENT DOING POST-OPERATIVELY? PATIENT REMAINS IN ICU, IS STILL INTUBATED, ON LEVOPHED, IN ATRIAL FLUTTER. ADDITIO

  Patient problems: Insufficient Information

  MAUDE report 22945984 ↗
• DeathJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION ON 05/25/2025, "MITRAL VALVE ONXM-25 WAS IMPLANTED AND VALVE GOT STUCK AND EXPLANTED THE VALVE. BUT UNFORTUNATELY, PATIENT DIED ON TABLE."

  Patient problems: Insufficient Information

  MAUDE report 22297430 ↗
• DeathMay 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 15APRIL2025 FROM ARTIVION SALES MANAGER NORTH INDIA, (B)(6)., MITRAL VALVE ONXM-25 WAS IMPLANTED. VALVE STOPPED FUNCTIONING AS PER DR. (B)(6) AND PATIENT VITALS STARTED GETTING DETERIORATED THEN REDO SURGERY WAS DONE WITH ANOTHER ONXM-25 MITRAL VALVE. ADDITIONAL INFORMATION RECEIVED RELAYED A 49-YEAR-OLD FEMALE HAD THE ONXM-25 VALVE IMPLANTED ON (B)(6) 2025 DUE TO RHD WITH SEVERE MITRAL REGURGITATION AND MODERATE MITRAL STENOSIS. MODERATE AORTIC REGURGITATION WITH ATRIAL FIBRILATION WITH SMALL AORTIC ROOT WITH AF WITH NYHA CLASS IV WAS ALSO PRESENT. AVR WITH AORTIC ROOT ENLARGEMENT BY NICK'S PROCEDURE WITH MVR WERE PERFORMED ON (B)(6) 2025. SURGERY WAS UNEVENTFUL, TEE SHOWED NORMAL PROSTHESIS FUNCTION. PATIENT WAS EXTUBATED NEXT MORNING AND WAS BEHAVING NORMAL. THE PATIENT DEVELOPED CARDIAC DYSFUNCTION ON 1ST POD AND WAS MANAGED; ACCORDINGLY, TEE WAS DONE WHICH SHOWED REGURGITATION ACROSS MITRAL PROSTHESIS. A RE-DO MVR WAS DONE ON (B)(6) 2025 DUE TO POSSIBLE PROSTHESIS DYSFUNCTION OR PARAVALVULAR LEAK WITH NEW PROSTHESIS IMPLANTED. THE PATIENT DEVELOPED SEVERE LEFT VENTRICULAR DYSFUNCTION AND WAS MANAGED WITH IABP AND IONOTROPIC

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 21999495 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT FROM ARTIVION REPRESENTATIVE, THE ONLY INFORMATION I HAVE AT THIS TIME IS THAT AN ON-X MITRAL VALVE "FAILED". ADDITIONAL INFORMATION RECEIVED FROM THE ARTIVION REPRESENTATIVE PER THE HOSPITAL'S CHARGE NURSE: SHE SAID THE DOCTOR IS NOT INTERESTED AT DISCUSSING FURTHER WITH ME. SHE DID SAY THE DOCTOR DID ACKNOWLEDGE THE VALVE COULD HAVE BEEN PLACED AT THE WRONG ANGLE/POSITION OR A SUTURE COULD HAVE IMPEDED FREE MOVEMENT OF THE LEAFLETS. NO ADDITIONAL INFORMATION WILL BE PROVIDED BY ACCOUNT.

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

  MAUDE report 21171006 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL EMAIL, "DURING THE ANNUAL ON-X CEP/CER CYCLE A POSTER PRESENTATION WAS FOUND ¿SUCCESSFUL THROMBOLYSIS IN A CASE OF ON-X MITRAL VALVE THROMBOSIS." THIS PUBLICATION REPORTS ON A CASE OF A 55-YEAR-OLD MALE WHO PRESENTED WITH PROGRESSIVE DYSPNEA AND ATRIAL TACHYCARDIA. THREE MONTHS PRIOR HE UNDERWENT A MV REPLACEMENT WITH A 31/33 ON-X VALVE FOR RHEUMATIC MITRAL STENOSIS. INR WAS 1.2 DESPITE BEING COMPLIANT WITH WARFARIN. TEE SHOWED SIGNIFICANT PROSTHETIC MV OBSTRUCTION AND THROMBOSIS WAS CONFIRMED BY FLUOROSCOPY AND TEE. SLOW-INFUSION, LOW-DOSE TPA WAS INITIATED HOWEVER HE DEVELOPED ACUTE DECOMPENSATION WITH NYHA IV SYMPTOMS AND WAS GIVEN A BOLUS OF TPA TO AVOID SURGERY. HIS CLINICAL STATUS IMPROVED SIGNIFICANTLY, AND A REPEAT TEE SHOWED RESOLVED MV OBSTRUCTION."

  Patient problems: Tachycardia; Thrombosis/Thrombus

  MAUDE report 20587251 ↗
• InjuryOct 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ARTIVION RECEIVED NOTIFICATION OF AN ONX MITRAL VALVE IMPLANT ONXMC-25/33, SN (B)(6), IMPLANT DATE ON (B)(6) 2014, FOR A PATIENT WITH AN EXISTING ONX MITRAL HEART VALVE ONXM-25, SN (B)(6), IMPLANT DATE ON (B)(6) 2011. THIS INVESTIGATION IS RELEGATED TO ONXM-25, SN (B)(6) FOR EXPLANT.

  Patient problems: Insufficient Information

  MAUDE report 20452648 ↗
• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IMPLANT REGISTRATION CARD (IRC) FOR ONXMC-25/33 SN (B)(6), IMPLANT DATE (B)(6) 2024 RECEIVED BACK FROM THE USER FACILITY. THE DEVICE TRACKING DATABASE HAS AN EXISTING MITRAL VALVE FOR THIS PATIENT, ONXM-27/29 SN (B)(6), IMPLANT DATE (B)(6) 2024. THIS INVESTIGATION IS RELEGATED TO ONXM-27/29 SN (B)(6) FOR EXPLANT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19994524 ↗
• DeathMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, THIS PATIENT UNDERWENT SURGERY FOR MITRAL VALVE REPLACEMENT ON (B)(6) 2024 AND EXPERIENCED BLEEDING DUE TO AV DISJUNCTION (DISCONNECTION OF THE LEFT ATRIUM AND THE LEFT VENTRICLE CAUSING A RUPTURE OF THE LEFT VENTRICULAR FREE WALL. THIS PATIENT DIED DUE TO THESE COMPLICATIONS. THIS DEVICE IS NOT EXPECTED TO BE RETURNED TO ARTIVION FOR ANALYSIS.

  Patient problems: Heart Failure/Congestive Heart Failure; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 19309982 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION: OLD PATIENT WITH SEVERE COMPLICATION ONE LEAFLET DOESN¿T OPEN PROPERLY . DOCTOR REPLACE ONX VALVE BY ANOTHER TISSUE VALVE. CASE DATE: NOVEMBER 2022 SERIAL NUMBER AND BATCH NUMBER OF THE USED VALVE NOT AVAILABLE.

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

  MAUDE report 17975028 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT SUBMITTED BY AN ON-X PATIENT, "I HAD AORTIC VALVE REPLACEMENT AND MITRAL VALVE REPLACEMENT IN (B)(6) 2022. SZMM 25 SN: (B)(6); SZMM19, SN (B)(6). ACCORDING TO ECHO VALVES ARE NOT WORKING, I STILL HAVE AORTIC STENOSIS AND MITRAL VALVE REGURGITATION, AND NOW TRICUSPID VALVE HAS REGURGITATION. I HAVE SHORTNESS OF BREATH, LOSS OF BALANCE, FATIGUE, AND FEEL WORSE THAN BEFORE SURGERY. I AM NOT HAPPY WITH CURRENT CARDIOLOGIST AND MY SURGEON HAS LEFT AREA." THIS REPORT WILL BE RELEGATED TO ONXM-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: Balance Problems; Dyspnea; Fatigue; Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 16911333 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, THIS ONXM-27/29 SN (B)(6) WAS IMPLANTED ON (B)(6) 2021 IN WHICH A REDO PROCEDURE WAS PERFORMED.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 16146327 ↗
• InjuryMay 31, 2022Break; Break

  ACCORDING TO THE INITIAL REPORT, "[SURGEON], CARDIAC SURGEON AT [HOSPITAL], REMOVED AN ONXMC25/33 VALVE WITH A BROKEN LEAFLET ON A PATIENT WHO ARRIVED IN EMERGENCY. SHE DECLARED A SERIOUS INCIDENT ON THE VALVE. I SAW THE VALVE, AND I CONFIRM THE REFERENCE AND THE LEAFLET BROKEN. THE FIRST INFORMATION COMES FROM THE PHARMACIST, [PHARMACIST]. ACCORDING TO THE FIRST INFORMATION AT MY DISPOSAL, THE PATIENT IS (B)(6) AND WAS OPERATED SIX YEARS AGO IN (B)(6)."

  Patient problems: Dyspnea; Hemoptysis; Pulmonary Edema; Tachycardia; Unspecified Heart Problem

  MAUDE report 14548081 ↗
• InjuryDec 22, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INITIAL REPORT RECEIVED, "I HAVE RECEIVED NOTIFICATION FROM [USER FACILITY] THIS MORNING THAT THEY ARE UNDERTAKING AN EMERGENCY EXPLANT OF AN ON-X MITRAL VALVE ONM-25 (IMPLANTED (B)(6) 2020 AT [USER FACILITY] - S/N (B)(4)) DUE TO MISSING LEAFLET. I DON¿T HAVE ANY FURTHER DETAILS AT THIS STAGE ¿ THEY ARE CURRENTLY TRYING TO FIND AND RECOVER THE MISSING LEAFLET. CAN YOU PLEASE ADVISE NEXT STEPS AND INFORMATION REQUIRED ASAP FOR PROGRESSING THE FOLLOW UP AND ANYONE ELSE THAT NEEDS TO BE NOTIFIED. I WILL KEEP YOU POSTED WITH ANY FURTHER DEVELOPMENTS AND UPDATES AS THEY COME THROUGH." ADDITIONAL INFORMATION STATED, "PATIENT WAS PLAYING ON LARGE WATERSLIDE ON (B)(6). THEN WAS AT A CREEK SWIMMING ON THE AFTERNOON OF (B)(6) AND DOING SOME JUMPING (BOMBING) INTO WATER OFF A TREE/LOG. FELT SHORT OF BREATH IN CAR ON WAY HOME. COULD BARELY WALK/GET OUT OF CAR. PATIENT DEVELOPED ACUTE PULMONARY EDEMA AND DEVELOPED CARDIOGENIC SHOCK AND HYPOXIA. REQUIRED EMERGENCY SURGERY ON ADMISSION TO HOSPITAL. ONE LEAFLET FOUND TO BE MISSING FROM VALVE. PATIENT SCANNED 2 DAYS LATER AND VALVE LEAFLET WAS FOUND TO BE FRACTURED INTO 2 PARTS ¿ APPROX. 70% IN ABDOMINAL AORTIC BIFURCATION AND REMA

  Patient problems: Cardiogenic Shock; Hypoxia; Pulmonary Edema

  MAUDE report 13060545 ↗
• InjuryOct 19, 2021Device Handling Problem; Device Handling Problem

  ACCORDING TO INITIAL REPORTS, "ON X MITRAL 25 WAS EXPLANTED AND A DIFFERENT ONX M 25 WAS SUCCESSFULLY IMPLANTED. SURGEON STATED THAT THE ORIGINAL VALVE HAD AN IMMOBILE LEAFLET." ADDITIONAL INFORMATION RECEIVED. "THE PATIENT DID SUFFER SOME ADVERSE EVENTS ¿ THE PATIENT HAD TO GO BACK ON BYPASS AND RE-ARREST THE HEART. THIS ADDED PUMP TIME. WHEN THE FIRST VALVE WAS SEATED, THE WHITE HOLDER DID NOT WANT TO RELEASE APPROPRIATELY. THE PATIENT IS CURRENTLY RECOVERING AS EXPECTED IN THE CVICU." THE VALVE WILL BE RETURNED. THE HOLDER WILL NOT.

  Patient problems: Insufficient Information

  MAUDE report 12657613 ↗

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