On-X Mitral Heart Valve with Conform-X Sewing Ring ONXMC-25/33Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00851788001303), received between Jan 5, 2016 and Jan 16, 2026 — classified as 1 death, 30 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (8 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 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.

Recalls naming this device

1. Feb 1, 2026Class IIOpen, Classified

   Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

   Z-2133-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED FROM JAPAN ON-X DISTRIBUTOR, AN ON-X CONFORM-X MITRAL VALVE BEING PLACED UPSIDE DOWN. ADDITIONAL INFORMATION RECEIVED: IS IT THAT WHEN THEY OPENED AN ON-X CONFORM-X MITRAL PACKAGE THAT THE VALVE WAS MOUNTED UPSIDE DOWN? AS IN, A PRODUCTION ERROR? WHEN THE ON-X CONFORM-X MITRAL VALVE WAS OPENED, IT WAS INSTALLED IN THE CORRECT ORIENTATION. THIS IS NOT A MANUFACTURING ERROR. DID THEY INADVERTENTLY CHOOSE AN ON-X AORTIC WITH CONFORM-X CUFF OFF THE SHELF AND THEN IMPLANT IT IN THE PATIENT¿S MITRAL POSITION? THE CONFORMX MITRAL 25/33 WAS SELECTED AND IMPLANTED INTO THE PATIENT'S MITRAL VALVE (INITIAL IMPLANTATION). AFTER INITIAL IMPLANTATION IN THE MITRAL VALVE, THE CONFORMX MITRAL 25/33 WAS REMOVED FROM THE PATIENT. WHEN RE-IMPLANTING THE REMOVED CONFORMX MITRAL 25/33 INTO THE PATIENT'S MITRAL VALVE, IT WAS IMPLANTED UPSIDE DOWN IN THE MITRAL VALVE (SECOND IMPLANTATION). DID THEY DISMOUNT THE ON-X CONFORM-X MITRAL VALVE PRIOR TO SUTURE PASS THROUGH THE CUFF, AND THEN TRY TO ¿RE-MOUNT¿ THE VALVE ON THE HOLDER BUT ACCIDENTALLY RE-MOUNTED IT BACKWARDS? DURING THE INITIAL IMPLANTATION, THE ON-X CONFORM-X MITRAL VALVE WAS REMOVED AFTER THE SUTURE THR

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24093649 ↗
• DeathNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE OCT 2025 ANNUAL LITERATURE SEARCH FOR ON-X HEART VALVES (AORTIC AND MITRAL) FOR SUSTAINING MDR REPORTING WE DISCOVERED THE FOLLOWING PUBLICATION BY HONGANUR ET AL ¿SHOCK AFTER REDO SURGERY FOR MECHANICAL MITRAL VALVE THROMBOSIS¿. THIS IS A CASE REPORT OF AN: 74-YEAR-OLD FEMALE WITH HISTORY OF ON-X #25/33 MM MECHANICAL MITRAL VALVE REPLACEMENT (MVR) SECONDARY TO RHEUMATIC HEART DISEASE PRESENTED WITH 2 DAY HISTORY OF WORSENING DYSPNEA AND HEMOPTYSIS. INR WAS 2.2. TEE: RESTRICTED MOTION OF MEDIAL PROSTHETIC DISK DUE TO LARGE THROMBUS & FREE MOTION OF LATERAL DISK. COLOR DOPPLER: MILD MR. FOLLOWING 2 WEEKS OF ANTICOAGULATION WITH HEPARIN AND WARFARIN HER SYMPTOMS PERSISTED AND LHC REVEALED ONGOING OBSTRUCTION OF MEDIAL DISK AND MODERATE LAD AND DIAGONAL DISEASE. HEART TEAM RECOMMENDED AGAINST THROMBOLYSIS OR CATHETER-BASED THERAPIES DUE TO LARGE THROMBUS BURDEN. SHE WAS DEEMED HIGH, NOT PROHIBITIVE, RISK FOR REDO MVR; SHE WAS AGREEABLE. SHE UNDERWENT TWO VESSEL BYPASS SURGERY AND MVR WITH A BIOPROSTHESIS. SURGERY WAS COMPLICATED BY SHOCK AND INCESSANT VENTRICULAR ARRHYTHMIA. POST-SURGERY, SHOCK WORSENED AND SHE WAS TRANSITIONED TO COMFORT CARE. THIS INVESTIGATION IS RELEGAT

  Patient problems: Shock; Thrombosis/Thrombus

  MAUDE report 23522888 ↗
• InjurySep 4, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  ACCORDING TO INITIAL REPORTS, "VALVE WAS IMPLANTED IN A 48-YEAR-OLD PATIENT WITH NO SPECIFIC REPORTED ISSUE. PATIENT WAS WELL. THE NEXT DAY, AN ISSUE WAS REPORTED AND THE VALVE WAS CHECKED VIA ULTRASOUND ECHOGRAPHY FOR A SUSPECTED INSUFFICIENT MOBILITY OF ONE OF THE TWO VALVE BLADES. VALVE REMOVED AND REPLACED ON (B)(6) 2025 BECAUSE ONE OF THE TWO BLADES WAS IMMOBILE. PATIENT WAS TREATED A SECOND TIME. VALVE WAS EXPLANTED AND REPLACED BY A NEW ONE. PATIENT DIED FROM THIS SECOND INTERVENTION." THIS INVESTIGATION IS RELEGATED TO ONXMC-25/33, SN (B)(6), FOR ALLEGED LEAFLET IMMOBILITY.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22962826 ↗
• InjuryJul 2, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  AN IRC (IMPLANT REGISTRATION CARD) FOR ONXM-27/29 A0389008, IMPLANT DATE - (B)(6) 2025 WAS RECEIVED FROM THE USER FACILITY FOR A PATIENT WITH A PREVIOUS ON-X MITRAL IMPLANT, ONXMC-25/33 (B)(6), IMPLANT DATE (B)(6) 2023. THIS EVENT IS RELEGATED TO ONXMC-25/33 (B)(6) FOR EXPLANT.

  Patient problems: Insufficient Information

  MAUDE report 22385967 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A MITRAL IMPLANT REGISTRATION CARD (IRC) WAS RECEIVED FOR A PATIENT WITH AN EXISTING MITRAL IMPLANT, INDICATING EXPLANT OF THE ORIGINAL MITRAL VALVE.

  Patient problems: Insufficient Information

  MAUDE report 21587856 ↗
• InjuryJan 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO INITIAL REPORTS, A 37 YEAR OLD PATIENT WITH ONXMC-25/33 EXPERIENCED HEMORRHAGIC STROKE . THE DEVICE REMAINS IMPLANTED.

  Patient problems: Hemorrhagic Stroke

  MAUDE report 21137635 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "ON (B)(6) 2023, THE PATIENT UNDERWENT MITRAL VALVE REPLACEMENT DUE TO MITRAL STENOSIS. ONE MONTH LATER, MITRAL VALVE DYSFUNCTION AND VALVE OBSTRUCTION OCCURRED. ON (B)(6), 2023, AN EMERGENCY OPERATION WAS PERFORMED TO REPLACE THE MECHANICAL VALVE AGAIN. DURING THE OPERATION, A LARGE NUMBER OF THROMBI WERE FOUND IN THE ATRIUM AND ACCUMULATED ON THE VALVE. IT WAS CONSIDERED THAT THE PATIENT'S HYPERCOAGULABLE CONSTITUTION LED TO THE VALVE OBSTRUCTION."

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21068791 ↗
• InjuryDec 5, 2023Incomplete Coaptation; Incomplete Coaptation

  ACCORDING TO THE INITIAL REPORT RECEIVED, "ON-X VALVE WAS IMPLANTED. WHEN REVIEWING THE VALVE THE LEAFLETS WERE NOT MOVING. THE VALVE WAS EXPLANTED AND AN ALTERNATE VALVE WAS IMPLANTED. AFTER REMOVAL, THE LEAFLETS WERE MOVING AGAIN."

  Patient problems: Insufficient Information

  MAUDE report 18265995 ↗
• InjuryOct 6, 2023Perivalvular Leak; Perivalvular Leak

  A MITRAL EIRC (ELECTRONIC IMPLANT REGISTRATION CARD) WAS RECEIVED FOR A PATIENT WITH AN EXISTING MITRAL VALVE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE EXPLANTING FACILITY: -THE RECORDS ARE THAT THIS PATIENT HAD A RE-DO IN (B)(6) 2020 WITH AN AORTIC AND MITRAL VALVE FOR A LEAK. HE DID WELL UNTIL (B)(6) 2022 WHEN A PERIVALVULAR LEAK WAS FOUND AROUND THE MITRAL. HE WENT TO THE CATH LAB TO ATTEMPT TO PLUG IT. HE THEN CAME BACK IN (B)(6) AS THE PLUG HAD NOT RESOLVED THE ISSUE. THE LEAK WAS DEEMED TOO LARGE TO PLUG AND WITH PULMONARY HYPERTENSION AND HIGH BLOOD PRESSURES, [SURGEON] DEEMED IT NECESSARY TO REPLACE IT. RECEIVED IN A CONTAINER LABELLED WITH PATIENT'S NAME AND "EXPLANTED MECHANICAL MITRAL VALVE" IS A SPECIMEN CONSISTING OF A STRUCTURALLY INTACT MECHANICAL CARDIAC VALVE THAT MEASURES 4.1 CM IN OUTER DIAMETER AND 2.5 CM IN INNER DIAMETER. BOTH LEAFLETS ARE STRUCTURALLY INTACT AND MOBILE. THERE IS NO PANNUS, TISSUE DEHISCENCE, OR SURFACE THROMBUS. THERE ARE SMALL BITS OF PERI VALVULAR SOFT TISSUE THAT MEASURES 0.6 CM. THIS VALVE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885569 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 08SEPT2023, A ON-X MITRAL IMPLANT REGISTRATION CARD RETURNED FROM THE USER FACILITY IS FOR A PATIENT WITH AN EXISTING ON-X MITRAL VALVE IMPLANTED. THE ARTIVION FIELD REPRESENTATIVE REPLIED TO THE REQUEST FOR ADDITIONAL INFORMATION AS FOLLOWS "I TRIED SEVERAL TIMES TO GET INFO ON THIS VALVE, BUT NEVER RECEIVED A RESPONSE. THERE WAS NEVER A COMPLAINT FROM THE SURGEON OR ANYONE ELSE ABOUT THIS VALVE." NO ADDITIONAL INFORMATION FORTHCOMING. THIS INVESTIGATION IS RELEGATED TO ONXMC-25/33. SERIAL NUMBER: (B)(6).

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

  MAUDE report 17885532 ↗
• InjuryJul 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT WAS BROUGHT BACK TO THE OR DUE TO SOME TYPE OF "ISSUE VALVE RELATED". IT WAS NOTED THE SURGEON WAS ABLE TO FIX THE ALLEGED ISSUE ROTATING THIS VALVE. THIS ON-X VALVE REMAINS IMPLANTED. ACCORDING TO THE SURGEON, THE PATIENT'S NATIVE ¿SUBVALVULAR TISSUE WAS CAUGHT AND COULD NOT ROTATE VALVE. OPENED ANOTHER VALVE TO EVALUATE WHAT CAN BE DONE TO FREE THE LEAFLET. BROUGHT PT [PATIENT] BACK TWO DAY LATER TO EXPLORE TRANS AORTIC AND I WAS ABLE TO RESECT SUBVALVULAR TISSUE AND FREE THE LEAFLET. PT IS DOING WELL NOW.¿

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

  MAUDE report 17330762 ↗
• InjuryJul 6, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO INITIAL REPORTS SURGEON PERFORMED A DOUBLE VALVE SURGERY. HE FIRST IMPLANTED AN ONX MITRAL CONFORM-X WITHOUT ANY COMPLICATIONS. THEN HE PROCEEDED TO IMPLANT THE AORTIC VALVE, HOWEVER THE ANNULUS WAS TOO SMALL FOR AN ON-X 19MM, THUS HE INCREASED THE ANNULUS AND IMPLANTED AN 19MM ON-X VALVE IN THE SECOND TRY. WHEN CIRCULATION WAS RESTORED, A MITRAL INSUFFICIENCY WAS DETECTED. THEY OPENED THE PATIENT AND FOUND THAT ONE OF THE MITRAL VALVES WAS BROKEN AND THE PIECE MISSING. THE SURGEON EXPANDED THE MITRAL CONFORM-X AND IMPLANTED A 27/29 MITRAL ON-X WITHOUT FURTHER COMPLICATIONS." DATE OF EVENT: (B)(6) 2023. PRODUCT SERIAL NUMBER UNKNOWN AT THIS TIME.

  Patient problems: Insufficient Information; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17269806 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO INITIAL REPORTS PATIENT IS UNDERGOING REOPERATION FOR PVL (PARAVALVULAR LEAK) AND HEMOLYTIC ANEMIA. DATE OF IMPLANT - (B)(6)2022. DATE OF EXPLANT - (B)(6)2023. THIS INVESTIGATION IS RELEGATED TO ONXAE-21, SERIAL NUMBER (B)(6).

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17136007 ↗
• InjuryFeb 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO THE INITIAL REPORT RECEIVED, "RECEIVED AN ONXMC IMPLANT (SN (B)(4) ONXMC-25/33) FOR AN EXISTING MITRAL PATIENT." AT THIS TIME, THE CAUSE FOR EXPLANT IS UNKNOWN. THIS INVESTIGATION IS RELEGATED TO ONXMC-25/33 (B)(4). 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: Insufficient Information

  MAUDE report 16364795 ↗
• InjuryFeb 1, 2023Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  IMPLANT SUMMARY CARD FOR ONXM-31/33, SN (B)(4) WAS RECEIVED BACK FROM THE USER FACILITY. IMPLANT DATE (B)(6) 2022. UPON ENTERING THE INFORMATION INTO THE DEVICE TRACKING DATABASE, ONXM-31/33, SN (B)(4) EXISTS FOR THIS SAME PATIENT. IMPLANT DATE (B)(6) 2022. THIS INVESTIGATION IS RELEGATED TO ONXM-31/33, SN (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Valvular Insufficiency/ Regurgitation

  MAUDE report 16280401 ↗
• InjuryDec 21, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORT RECEIVED FROM THE ARTIVION SALES REPRESENTATIVE (ASR), " THE PATIENT DEVELOPED HEART FAILURE MORE THAN 5 MONTHS AFTER THE VALVE WAS IMPLANTED AND WAS ADMITTED TO THE HOSPITAL. AFTER RE-EXAMINATION OF CARDIAC ULTRASOUND, THE DEVELOPMENT OF MECHANICAL VALVE MITRAL VALVE POSITION WAS LIMITED, AND THE EMERGENCY SURGERY OF CARDIAC SURGERY WAS REOPERATED, AND THE DEVELOPMENT OF ONE VALVE LEAFLET ON ONE SIDE OF THE MECHANICAL VALVE WAS FOUND TO BE LIMITED DURING SURGERY." A QUERY OF THE ARTIVION DEVICE TRACKING DATABASE FOUND SERIAL NUMBER: (B)(4) TO BE ASSOCIATED WITH AN ONXACE-23. A REQUEST HAS BEEN SENT TO CONFIRM THIS INFORMATION. A BRIEF HISTORY OF THE PATIENT FROM THE SURGEON IS AS FOLLOWS: 50Y FEMALE. THE CHIEF COMPLAINT IS REPEATED SHORTNESS OF BREATH FOR 5 DAYS AND AGGRAVATION FOR 1 DAY. THE ADMITTING DIAGNOSIS IS HEART FAILURE. CARDIAC DOPPLER ECHOCARDIOGRAPHY AFTER ADMISSION INDICATES THAT THE OPENING OF MECHANICAL MITRAL VALVE IS LIMITED. AFTER THE SECOND OPERATION, THE PATIENT HAS RECOVERED SMOOTHLY AND CAN NOW WALK ON THE GROUND. A RESPONSE FROM THE ARTIVION REPRESENTATIVE RELAYED THE SERIAL NUMBER TO BE (B)(4). A QUERY OF THE DEVICE TRACKING SYSTEM I

  Patient problems: Heart Failure/Congestive Heart Failure; Thrombosis/Thrombus

  MAUDE report 16021880 ↗
• InjuryOct 31, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A REPORT WAS RECEIVED STATING AN ON-X MITRAL VALVE "DID NOT WORK PROPERLY". THE PRODUCT HAS BEEN RETURNED AND WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 15698695 ↗
• InjuryAug 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "RECEIVED A SECOND MITRAL IMPLANT FOR THIS PATIENT. SN (B)(4). ONLY TOP HALF OF IRC WAS RECEIVED, SO SURGEON IS UNKNOWN."

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 15141957 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, ONXMC-25/33 SERIAL NUMBER (SN) (B)(4) WAS IMPLANTED ON (B)(6) 2022 AND EXPLANTED ON (B)(6) 2022. CAUSE OF EXPLANT IS STILL CURRENTLY UNKNOWN.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 14742883 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "RECEIVED A MITRAL POSITION MITRAL IMPLANT FOR A PATIENT THAT ALREADY HAS ONE. ONE ON (B)(6) 2020 ONE ON (B)(6) 2021. SECOND IMPLANT SN (B)(4) ONXMC 25/33." THIS INVESTIGATION WILL BE RELEGATED TO ONXMC 25/33, SN (B)(4). ADDITIONAL QUESTIONS WERE ANSWERED BY THE USER FACILITY: WHY WERE THE VALVES EXPLANTED? WAS THERE A DEFICIENCY? THEY WERE ORIGINALLY IMPLANTED (B)(6) 2020 WITH THE EXPECTATION OF TERMINATION OF DRUG USE. SHE RETURNED (B)(6) 2021 WITH ENDOCARDITIS AND HAD TO BE EXPLANTED. (B)(6) 2020 SN#(B)(4) TRICUSPID POSITION SN#(B)(4) MITRAL POSITION. (B)(6) 2021 SN#(B)(4) TRICUSPID POSITION SN#(B)(4) MITRAL POSITION. WILL THE EXPLANTED VALVES BE RETURNED? WE HAD NO INTENT TO RETURN THE VALVES DUE TO THE REASON FOR EXPLANT. WHY WERE THE VALVES ORIGINALLY IMPLANTED? STATED EARLIER HOW IS THE PATIENT POST-OPERATIVELY? POOR CONDITION. MANY CO-MORBIDITIES. ARE OPERATIVE NOTES AVAILABLE FOR US TO REVIEW? I DO NOT THINK THAT THE NOTES ARE AVAILABLE FOR REVIEW. NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Endocarditis

  MAUDE report 11738053 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "RECEIVED A TRICUSPID POSITION MITRAL IMPLANT FOR A PATIENT THAT ALREADY HAS ONE. ONE ON (B)(6) 2020 ONE ON (B)(6) 2021. SECOND IMPLANT SN (B)(4) ONXMC 25/33". THIS INVESTIGATION WILL BE RELEGATED TO ONXMC 25/33, SN (B)(4). ADDITIONAL QUESTIONS WERE ANSWERED BY THE USER FACILITY: WHY WERE THE VALVES EXPLANTED? WAS THERE A DEFICIENCY? THEY WERE ORIGINALLY IMPLANTED (B)(6) 2020 WITH THE EXPECTATION OF TERMINATION OF DRUG USE. SHE RETURNED (B)(6) 2021 WITH ENDOCARDITIS AND HAD TO BE EXPLANTED. ON (B)(6) 2020 SN#(B)(4) TRICUSPID POSITION SN#(B)(4) MITRAL POSITION. ON (B)(6) 2021 SN#(B)(4) TRICUSPID POSITION SN#(B)(4) MITRAL POSITION. WILL THE EXPLANTED VALVES BE RETURNED? WE HAD NO INTENT TO RETURN THE VALVES DUE TO THE REASON FOR EXPLANT. WHY WERE THE VALVES ORIGINALLY IMPLANTED? STATED EARLIER. HOW IS THE PATIENT POST-OPERATIVELY? POOR CONDITION. MANY CO-MORBIDITIES. ARE OPERATIVE NOTES AVAILABLE FOR US TO REVIEW? I DO NOT THINK THAT THE NOTES ARE AVAILABLE FOR REVIEW. NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Endocarditis

  MAUDE report 11737680 ↗
• InjuryJul 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IMPLANT REGISTRATION CARD WAS RECEIVED WITH "DISPOSED" LISTED AS THE STATUS.

  Patient problems: Complaint, Ill-Defined

  MAUDE report 8748443 ↗
• InjuryMay 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO AN EMAIL RECEIVED ON (B)(6)2018: "WHILE ENTERING SN (SERIAL NUMBER) FOR ONXMC 25/33 THE SYSTEM NOTIFIED ME OF A PREVIOUS IMPLANT IN SAME POSITION FOR SAME PATIENT." PREVIOUS IMPLANT IS ASSOCIATED WITH ANOTHER ONXMC 25/33 AND THIS VALVE IS THE ONE BEING INVESTIGATED.

  Patient problems: No Information

  MAUDE report 7475896 ↗
• InjurySep 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL REPORTS FROM THE PATIENT, "I HAVE YOUR ONXMC-25/33 MITRAL VALVE REPLACEMENT SINCE (B)(6) 2009. I HAD A MAJOR BLEEDING EPISODE ON WARFARIN A YEAR AGO. DON'T WANT ANOTHER! HOWEVER MY CARDIOLOGIST IS RAISING THE INR RANGE FOR MY VALVE." PATIENT CONTACTED CRYOLIFE WITH CONCERNS ABOUT HER PHYSICIAN INCREASING HER INR RECENTLY. AS OF (B)(6) 2017 THE PATIENT'S INR IS 2.0. THE PATIENT'S CONCERN STEM'S FROM A BLEEDING INCIDENT IN (B)(6) OF 2016 THE RESULTED IN A TWO WEEK HOSPITALIZATION.

  Patient problems: Blood Loss

  MAUDE report 6845056 ↗
• InjuryOct 5, 2016Leak/Splash; Leak/Splash

  ACCORDING TO THE INITIAL REPORT, "IMPLANT OF ONX MITRAL VALVE WENT FINE. WHEN THEY LOOKED AT ECHO THE FELT THAT THERE WAS A PERI VALVULAR LEAK. WE DISCUSSED THE UNIQUE SIGNATURE JETS OF THE ONX VALVE BUT ECHO AND SURGEON BOTH AGREED THAT THEY SAW A MILD TO MODERATE LEAK. SURGEON FELT THAT IT WAS NOT NECESSARY TO GO IN AND FIX. PT WAS CLOSED AND SURGERY WAS COMPLETED."

  Patient problems: No Code Available

  MAUDE report 6001364 ↗

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-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