On-X Mitral Heart Valve with Standard Sewing Ring ONXM-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00851788001273), received between Aug 11, 2015 and Sep 2, 2025 — classified as 6 deaths, 8 injuries, 3 malfunctions.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• DeathJun 26, 2020Adverse 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 REPORT ONXM 25 SN:(B)(6) WAS EXPLANTED ON (B)(6) 2020. THIS ON-X VALVE WAS REPLACED WITH ONXM 25 SN: (B)(6). AN OBITUARY FOR THE PATIENT WAS FOUND WITH DATE OF DEATH AS (B)(6) 2020. THIS INVESTIGATION IS RELEGATED TO ONXM 25 SN: (B)(6) AND ONXM SN: (B)(6).

  Patient problems: Death

  MAUDE report 10201432 ↗
• DeathMay 11, 2018Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO INITIAL REPORTS, ONXANE-21 SN (B)(4) IMPLANTED (B)(6) 2018, ONXM-25 SN (B)(4) IMPLANTED (B)(6) 2018 AND EXPLANTED (B)(6) 2018, ONXM-25 SN (B)(4) IMPLANTED (B)(6) 2018. DEATH OF PATIENT, ACCORDING TO OBITUARY FOUND ONLINE, (B)(6) 2018. THIS INVESTIGATION WILL BE RELEGATED TO ONXM-25 SN (B)(4). ACCORDING TO OPERATIVE NOTES RECEIVED, PREOPERATIVE DIAGNOSIS: PROGRESSIVE CARDIOVASCULAR DECLINE, STATUS POST PREVIOUS DOUBLE-VALVE PROCEDURE WITH KONNO ADAPTION REQUIRING RETURN TO THE OR FOR EVALUATION. POSTOPERATIVE DIAGNOSIS: EVIDENCE OF AN OBSTRUCTIVE LEAFLET: IN THE MITRAL PROSTHESIS REQUIRING REPLACEMENT. PROCEDURE: 1. EMERGENCY REPLACEMENT OF THE ST. JUDE MITRAL VALVE PROSTHESIS WITH A 25-MM ON-X VALVE ROTATED 90 DEGREES FROM THE ORIGINAL VALVE REPLACEMENT. 2. REPLACEMENT OF PREVIOUS MITRAL PROSTHESIS WITH A 25-MM ON-X PROSTHESIS. 3. INSTITUTION OF AV ECMO, 33947. 4. RECONSTRUCTION OF ATRIAL SEPTUM. 5. RECONSTRUCTION OF THE ATRIAL TREE WALL WITH A CORMATRIX PATCH. THE TRANSESOPHAGEAL ECHOCARDIOGRAM IN THE OPERATING ROOM CONFIRMED WITH THE 3D ECHO SHOWED ENTRAPMENT OF ONE LEAFLET OF THE MITRAL VALVE. CONDITION: THE PATIENT WAS TRANSPORTED TO THE CVICU IN GUARDED CONDITION.

  Patient problems: Aortic Valve Stenosis; Mitral Valve Stenosis; Sudden Cardiac Death

  MAUDE report 7507930 ↗
• DeathOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARD (IRC) RECEIVED INDICATES THAT PATIENT UNDERWENT DOUBLE VALVE SURGERY ON (B)(6) 2016 RECEIVING ONXANE-21 AND ONXM-25 INDICATED FOR SEVERE AORTIC INSUFFICIENCY AND SEVERE MITRAL REGURGITATION. PROCEDURE PERFORMED WAS "TRANSESOPHAGEAL ECHOCARDIOGRAM [TEE], MITRAL VALVE REPLACEMENT, CHORDAL SPARING (25 MM ON-X MECHANICAL VALVE), AORTIC VALVE REPLACEMENT (21 MM ON-X MECHANICAL VALVE), EXTENSIVE PERICARDIAL ADHESIOLYSIS SECONDARY TO EXTENSIVE PERICARDITIS." ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT DIED ON (B)(6) 2016. A PRELIMINARY AUTOPSY REPORT INDICATES THE FOLLOWING: PROVISIONAL ANATOMIC DIAGNOSES: CARDIOVASCULAR SYSTEM. STATUS POST (B)(6) 2016 AORTIC VALVE & RNLTRAL VALVE REPLACEMENT SURGERY. BOTH MITRAL & AORTIC ON-X PROSTHETIC HEART VALVES APPEAR PROPERLY POSITIONED & INTACT. SMALL EPICARDIAL ABSCESS (1 CM) AD]ACENT TO PROSTHETIC MITRAL VALVE B, HEART WITH CARDIOMEGALY (569 G). LEFT VENTRICULAR HYPERTROPHY. FOCAL SCARRING OF MYOMETRIUM SUGGESTIVE OF REMOTE INFARCT; NO ACUTE INFARCTION SEEN.. FIBRINOUS PERICARDITIS. CALCIFIC ATHEROSCLEROSIS OF CORONARY ARTERIES. PULMONARY SYSTEM. CONGESTED APPEARS TO LUNGS ,BILATERALLY (EACH LUNG 720 G). NO EVIDE

  Patient problems: Death

  MAUDE report 5995423 ↗
• 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 ONXM-25 ON (B)(6) 2014 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2014 AND REPLACEMENT WITH ANOTHER ONXM-27/29 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

  Patient problems: No Information

  MAUDE report 5995262 ↗
• MalfunctionApr 5, 2016Escape; Escape

  ECHO CHECK AFTER IMPLANT OF THE ONXM-25 INDICATED ONE OF THE LEAFLETS OF THE MITRAL VALVE WAS STUCK/NOT FUNCTIONING PROPERLY. SURGEON RE-OPENED TO INSPECT THE VALVE AND ONE LEAFLET WAS NOT FUNCTIONING. SHE ROTATED THE VALVE SEVERAL TIMES WITH THE 25MM ROTATOR BUT HAD DIFFICULTY AND EACH TIME SHE ROTATED, ONE SIDE OR THE OTHER WAS HITTING MUSCLE. SHE THEN USED A RUBBER-PADDED HEMOSTAT ( OR SIMILAR METALLIC INSTRUMENT), AS SHE FELT SHE COULDN'T GET ADEQUATE TORQUE ON THE MITRAL VALVE TO ROTATE IT ENOUGH. WHEN SHE TRIED THIS, ONE OF THE LEAFLETS BECAME DISLODGED. THE LOOSE LEAFLET WAS RETRIEVED AND SHE OPTED TO REPLACE THE 25MM VALVE WITH THE ONXMC-25/33. STANDARD TECHNIQUE WAS USED TO REDO THE MITRAL VALVE AND THE LEAFLETS WERE TESTED SEVERAL TIMES DURING THE CASE TO MAKE SURE THE LEAFLETS WERE NOT IMPINGING ON ANY SURROUNDING TISSUE. THE HEART WAS CLOSED AGAIN AND ECHO CARDIOLOGIST CONFIRMED THAT THE VALVE WAS FUNCTIONING PROPERLY. THE DAMAGED ONXM-25 VALVE WAS DISCARDED AT THE HOSPITAL AND COULD NOT BE RETRIEVED TO BE RETURNED FOR ANALYSIS. THE CONCLUSION DRAWN BASED ON THE DESCRIPTION ABOVE IS SIMPLY "IATROGENIC DAMAGE", AND NOT A MALFUNCTION DUE TO A LATENT DEFECT IN THE VALVE. T

  Patient problems: Iatrogenic Source

  MAUDE report 5548731 ↗
• MalfunctionFeb 24, 2016Mechanical Problem; Mechanical Problem

  DURING TRACKING DATABASE DATA ENTRY, IT WAS NOTED THAT THE SAME PATIENT HAD 2 MITRAL VALVE IMPLANTS, 1 IMPLANTED ON (B)(6) 2015, THEN ANOTHER ON (B)(6) 2015. CALLED HOSPITAL TO FIND OUT WHAT HAPPENED AND FOUND THAT THE FIRST VALVE HAD TO BE EXPLANTED BECAUSE ANATOMIC TISSUE LOOSENED AND INTERFERED WITH THE PROSTHETIC VALVE FUNCTIONALITY, RESULTING IN THE NEED TO DO A RE-DO MITRAL VALVE REPLACEMENT. THE FOLLOWING DESCRIPTION COMES FROM THE SURGEON'S OPERATIVE REPORT: AFTER REMOVAL OF THE MECHANICAL VALVE, IT WAS FOUND THAT THERE WERE LARGE SINUS POUCHES AT THE POSTERIOR WALL JUST BELOW THE POSTERIOR MITRAL ANNULUS/FIBROTIC TISSUE THAT WAS ATTACHED TO THE MITRAL VALVE. THESE POUCHES WERE NOT SEEN DURING THE LAST OPERATION, WHICH APPEARED COVERED BY THE MITRAL ANNULUS/FIBROTIC TISSUE. THE MITRAL ANNULUS/FIBROTIC TISSUE WAS ORIGINALLY ATTACHED TO THE VENTRICULAR WALL BELOW THE SINUS POUCHES, WHICH WAS PROBABLY DETACHED SUDDENLY FROM THE VENTRICULAR WALL LAST NIGHT, CAUSING THE MALFUNCTION OF THE PROSTHETIC MITRAL VALVE. THE PATIENT HAD TO BE RE-OPERATED AND A NEW ON-X VALVE WAS IMPLANTED, THIS TIME A LARGER SEWING RING MODEL WAS CHOSEN AND IT WAS SEATED HIGHER IN THE LEFT ATRIUM. PATIE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5457967 ↗
• MalfunctionAug 11, 2015Interference; Mechanical Problem; Appropriate Device Problem Term/Code Not Available

  EVENT OCCURRED IN (B)(6). ON-X MITRAL VALVE WAS USED IN MITRAL VALVE REPLACEMENT CASE. ECHO CHECK AFTER SURGERY FOUND SEVERE MITRAL REGURGITATION. SURGEON THOUGHT IT MIGHT BE DUE TO MALFUNCTION OF THE VALVE LEAFLET, NOT PARAVALVULAR LEAK. THE VALVE WAS EXPLANTED AND REPLACED. DR. (B)(6) WANTED TO KNOW IF THERE IS ANY PROBLEM WITH THE EXPLANTED VALVE. THE VALVE IS BEING RETURNED TO ON-X FOR INVESTIGATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Consequences Or Impact To Patient

  MAUDE report 4999233 ↗

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