On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder ONXACE-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851788001440), received between Nov 18, 2015 and Feb 21, 2025 — classified as 1 death, 4 injuries.

The most frequently reported specific device problem is “Perivalvular Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2025Adverse 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 (IRC) WAS RECEIVED FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT. ADDITIONAL INFORMATION PROVIDED THAT THE EXPLANT OCCURED DUE TO ¿IMPAIRED LEAFLET MOBILITY WITH CIRCUMFERENTIAL PANNUS BELOW THE MSAVR¿

  Patient problems: Insufficient Information

  MAUDE report 21435990 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT THE ONXACE-19 DEHISCED BECAUSE OF FRAGILE PUSSED AORTIC ROOT. PATIENT WAS TRANSFERRED AND THINKS THE PATIENT HAD A HOMOGRAFT IMPLANTED. PER THE HOSPITAL REPRESENTATIVE, "VALVE PERFORMED AS WELL AS IT SHOULD." NO ADDITIONAL INFORMATION FORTHCOMING.

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

  MAUDE report 17919571 ↗
• DeathAug 1, 2022Adverse 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 INITIAL REPORT RECEIVED ON 7/7/2022, ARTIVION CUSTOMER SERVICE RECEIVED A CALL FROM [PATIENT] STATING SHE IS AT THE HOSPITAL AND WAS TOLD SHE HAS A FAULTY ON-X VALVE IMPLANTED ON (B)(6) 2020.

  Patient problems: Insufficient Information; Stroke/CVA

  MAUDE report 15138000 ↗
• InjuryNov 13, 2017Perivalvular Leak; Perivalvular Leak

  ACCORDING TO THE IMPLANT REGISTRATION CARDS, FEMALE PATIENT IMPLANTED WITH ONXACE-19 (SN (B)(4)) ON (B)(6) 2013 AND REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2017 AND SUBSEQUENT REPLACEMENT VIA ONXAE-23.INDICATION FOR INTERVENTION PER OP NOTES RECEIVED- "THE PATIENT IS A (B)(6)-YEAR-OLD LADY, WHO HAD COARCTATION REPAIR AS A CHILD AND THEN AORTIC VALVE REPLACEMENT AND ASD REPAIR IN 2014. SHE NOW RETURNS SYMPTOMATIC WITH SEVERE PARAVALVULAR LEAK OUTSIDE THE AORTIC VALVE PROSTHESIS AND 3+ POSTERIORLY DIRECTED MITRAL REGURGITATION."

  Patient problems: Insufficiency, Valvular

  MAUDE report 7025077 ↗
• InjuryApr 8, 2016Perivalvular Leak; Perivalvular Leak

  THIS RE-OPERATION WAS OBSERVED WHEN REVIEWING IMPLANT REGISTRATION INFORMATION IN THE TRACKING SYSTEM DATABASE. ON-X INVESTIGATED AND OBTAINED THE OPERATIVE REPORT FOR THE RE-OPERATION. PER THE OP REPORT, THE PATIENT HAD ENDOCARDITIS (SEVERE AORTIC INSUFFICIENCY AND PARAVALVULAR LEAK, SECONDARY TO ENDOCARDITIS), 5 DAYS POST-OPERATIVELY. THE VALVE HAD DEHISCED (FROM SEWING RING-TO-TISSUE CONNECTION). ACUTE CONGESTIVE HEART FAILURE, AND ACQUIRED COAGULOPATHY. RE-DO AORTIC VALVE REPLACEMENT (AVR) WAS PERFORMED WITH AN ONXACE-23 , S/N (B)(4). POST-OP, PATIENT TRANSFERRED TO ICU IN STABLE CONDITION. TEE AT END OF CASE SHOWED EXCELLENT VALVE FUNCTION WITH MINIMAL GRADIENT. ENDOCARDITIS IS AN EXPECTED ADVERSE EVENT, DEFINED IN THE AATS/STS GUIDELINES AS VALVE-RELATED AND REPORTABLE, THEREFORE THIS IS BEING REPORTED. IT IS AMONG SEVERAL OTHER ADVERSE EVENTS POSSIBLE FOR HEART VALVE PATIENTS AS LISTED IN SECTION 5 OF THE IFU.

  Patient problems: Aortic Insufficiency; Congestive Heart Failure

  MAUDE report 5564710 ↗
• Nov 18, 2015Sticking

  PATIENT ADMITTED FOR AVR (AORTIC VALVE REPLACEMENT). ROOT ENLARGEMENT PERFORMED IN ORDER TO FIT A 19MM AORTIC VALVE. VALVE IMPLANTED SUCCESSFULLY. INTRA-OPERATIVE TEE SHOWED VALVE LEAFLETS TO BE FUNCTIONING PROPERLY. UPON FOLLOW-UP AFTER SURGERY (35 DAYS POST-OP), ECHO SHOWED ONE LEAFLET NOT CLOSING WELL, CAUSING AORTIC INSUFFICIENCY (AI), BUT PATIENT TOLERATED IT FINE. NO SUBVALVULAR OBSTRUCTION CAN BE SEEN ON ECHO AND NO OBSERVED THROMBOSIS OR SUTURE IMPINGEMENT, THOUGH THIS CANNOT ALWAYS BE SEEN ON ECHO. A SMALL THROMBUS WAS SUSPECTED AND LOW DOSE LYTIC THERAPY ADMINISTERED ON (B)(6) 2015 AND AGAIN ON (B)(6) 2015. REPEAT TEE SHOWING OFFENDING LEAFLET NOW MOVING MUCH BETTER, AI ONE PLUS. TARGET INR 3.5 PLUS ASPIRIN GOING FORWARD. AS THE ISSUE WAS CLEARED UP WITH LYTIC THERAPY, VALVE THROMBOSIS IS THE SUSPECTED CONDITION. THIS IS BEING REPORTED BECAUSE IT REQUIRED MEDICAL INTERVENTION TO PREVENT PERMANENT DAMAGE, AND VALVE THROMBOSIS IS DEFINED TO BE VALVE-RELATED AND REPORTABLE PER AATS/STS GUIDELINES.

  Patient problems: Aortic Insufficiency; Thrombosis

  MAUDE report 5233125 ↗

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