On-X Mitral Heart Valve with Standard Sewing Ring ONXM-31/33Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00851788001297), received between Sep 25, 2015 and Nov 24, 2025 — classified as 2 deaths, 7 injuries.

The most frequently reported specific device problem is “Break” (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 9 most recent of 9 reports, 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 ↗
• 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 ↗
• DeathFeb 11, 2020Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE INITIAL REPORT, THE PATIENT WAS IMPLANTED WITH ONXM-31/33 IN THE MITRAL POSITION ON (B)(6) 2019. ON (B)(6) 2020 AN ECHOCARDIOGRAM SHOWED A LEAFLET WAS MISSING AND HAD MIGRATED. THIS RESULTED IN CARDIOGENIC SHOCK AND METABOLIC ACIDOSIS. THE SURGEON ATTEMPTED MITRAL VALVE REPLACEMENT, BUT WAS UNSUCCESSFUL. THE PATIENT DEVELOPED PROLONGED HYPERTENSION AND HYPO PERFUSION, FOLLOWED BY MULTI-ORGAN FAILURE. THE PATIENT DID NOT LIVE. RADIOGRAPHIC SCANS SHOW THE DISLODGED VALVE AT THE LEVEL OF THE L2 VERTEBRA. REFERENCE MEDWATCH REPORT MW5092348.

  Patient problems: Death

  MAUDE report 9694503 ↗
• InjuryApr 3, 2018Perivalvular Leak; Perivalvular Leak

  ACCORDING TO REPORTS FROM THE PATIENT'S WIFE, "THEY REMOVED THE MECHANICAL VALVE AND REPLACED IT WITH A TISSUE VALVE." BASED ON INFORMATION OBTAINED FROM A PREVIOUS EVENT, THE EXPLANT WAS DUE TO PARAVALVULAR LEAK. PLEASE REFERENCE MANUFACTURER REPORT NUMBER 1649833-2018-00001 FOR PREVIOUSLY REPORTED EVENT .

  Patient problems: Congestive Heart Failure

  MAUDE report 7392990 ↗
• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INFORMATION RECEIVED, A (B)(6) MALE RECEIVED AN ONXM-31/33 ((B)(4)) ON (B)(6) 2017 AND REQUIRED RE-INTERVENTION/EXPLANT ON (B)(6) 2017 DUE TO SEVERE LARGE POSTERIOR DEHISCENCE OF PRIOR MITRAL PROSTHESIS. IT WAS REPLACED WITH AN ONXMC-25/33 VALVE.

  Patient problems: Heart Failure; Regurgitation

  MAUDE report 7112188 ↗
• DeathApr 10, 2017Break; Break

  ACCORDING TO THE INITIAL EMAIL FROM THE DISTRIBUTOR, "I REPORT YOU THE ACCIDENT HAPPENED TODAY ABOUT LEAFLET'S ESCAPE. ONE LEAFLET OF MITRAL 31/33, WHICH IMPLANTED ON (B)(6) 2013 TO THE (B)(6) MALE, WAS ESCAPED AND TRAPPED AT KIDNEY ARTERY. PATIENT WAS OPERATED TODAY AND REPLACED TO BIOLOGICAL VALVE BUT ESCAPED LEAFLET HAS NOT YET TAKEN OUT. THE PATIENT CONDITION IS NOT SO WELL HE HAS BEEN UNDER PCPS SINCE YESTERDAY WHEN HE WAS DELIVERED AS EMERGENCY PATIENT." ADDITIONAL INFORMATION FROM ANOTHER REPRESENTATIVE AT (B)(6) INDICATED THE FOLLOWING: "WE HAVE RECEIVED A SERIOUS COMPLAINT REGARDING ON-X MITRAL VALVE FROM HOSPITAL SAYING THAT ONE SIDE OF THE LEAFLETS WAS TOLD TO BE COME OFF OR FRAGMENTED (STILL UNKNOWN) FROM THE VALVE HOUSING. CT SCANNED PICTURE TELLS THE DETACHED LEAFLET SEEMS TO BE STAYING NEAR RENAL ARTERY, BUT DOCTORS ARE STILL NOT SURE WHETHER FRAGMENTED PARTS (IF THERE ARE) IN OTHER PARTS OF THE BODY. THE PATIENT IS A MALE, WHO HAD MVR (ON-X M VALVE) AND TRICUSPID VALVE PLASTY AT THE SAME TIME IN 2013, BEING BROUGHT TO THE HOSPITAL DUE TO RESPIRATORY FAILURE WAS FINALLY FOUND TROUBLE WITH THE REPLACED MITRAL VALVE. A BIOLOGICAL VALVE WAS USED TO REPLACE THE TROUBLED

  Patient problems: Death; Embolism; Foreign Body In Patient

  MAUDE report 6475529 ↗
• InjurySep 29, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE (B)(6), PATIENT IMPLANTED WITH ONXM 31/33 ON (B)(6) 2006 AND REQUIRED INTERVENTION/EXPLANT DUE TO "BIOPROSTHETIC MITRAL STENOSIS" ON (B)(6) 2016 AND WAS REPLACED WITH AN ONXMC-25/33.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 5986527 ↗
• InjurySep 25, 2015Obstruction of Flow

  EMAIL FROM SURGEON IN (B)(6) STATES HE HAD A PATIENT WITH AN OBSTRUCTION OF HIS ON-X VALVE IN THE TRICUSPID POSITION (AN OFF-LABEL USE OF THE ON-X VALVE, DONE AT THE SOLE DISCRETION OF THE SURGEON). THIS PATIENT HAD PREVIOUS MITRAL AND TRICUSPID REPLACEMENTS > 10 YEARS AGO, AND UNDER ANTICOAGULATION WITH DICUMAROL. THE REPORT ALLEGES THE PATIENT DEVELOPED PANNUS FORMATION ON THE TRICUSPID VALVE. THE SURGEON RE-OPERATED AND REPLACED THE ON-X VALVE IN THE TRICUSPID POSITION WITH A TISSUE VALVE. THE PATIENT IS DOING FINE. THE SURGEON WAS LOOKING FOR LITERATURE REFERENCES ON OBSTRUCTION W/ PANNUS OF A TRICUSPID VALVE. THE SURGEON WAS INFORMED THAT THERE HAVE BEEN NO CONFIRMED REPORTS OF PANNUS WITH THE ON-X HEART VALVES. ON-X INQUIRED AS TO AVAILABILITY OF THE VALVE FOR RETURN FOR INVESTIGATION, TO WHICH NO RESPONSE WAS RECEIVED. CURRENTLY WORKING WITH THE DISTRIBUTOR IN (B)(4) TO ATTEMPT GETTING THE VALVE BACK TO DETERMINE IF THE MATERIAL IS ACTUALLY PANNUS OR THROMBUS. IN 1 PAST PATHOLOGY INVESTIGATION, ALLEGED PANNUS WAS FOUND TO BE THROMBUS. IF FURTHER INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. THIS IS BEING REPORTED BECAUSE IT WAS REQUIRED THAT THE PATIENT UN

  Patient problems: Corneal Pannus

  MAUDE report 5104311 ↗

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