On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder ONXANE-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00851788001662), received between Mar 10, 2016 and Feb 18, 2026 — classified as 2 deaths, 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, AN AORTIC IMPLANT REGISTRATION CARD WAS RECEIVED FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT, INDICATING THE ORIGINAL WAS EXPLANTED.

  Patient problems: Endocarditis; Unspecified Heart Problem

  MAUDE report 24376605 ↗
• InjuryJul 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED ON (B)(6) 2025 "RECEIVED AN AORTIC IMPLANT FOR PATIENT WITH EXISTING AORTIC IMPLANT (13 DAY REDO)". THIS INVESTIGATION IS RELEGATED TO ONX AORTIC VALVE, ONXANE-23, SERIAL NUMBER A0814604 THAT WAS EXPLANTED.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22480926 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DESCRIPTION OF REPORTED ADVERSE EVENT/PROBLEM: ACCORDING TO THE INITIAL NOTIFICATION, "THE REP CALLED ME FROM THE OR TO CONSULT ON THIS SITUATION WHERE THE SURGEON HAS IMPLANTED THE VALVE, TAKEN THE PATIENT OFF PUMP AND UPON VIEWING ECHO IT APPEARED AS IF ONE OF THE LEAFLETS WAS NOT MOVING SYNCHRONOUSLY W OTHER LEAFLET AND NOT ACHIEVING FULL RANGE OF MOTION OF THE TRAVEL ARC. ¿STICKY LEAFLET¿ OR ¿LEAFLET LAG¿ IN GENERAL TERMS. EVIDENCE OF A HIGHER THAN EXPECTED GRADIENT WAS RECORDED INTRA-OPERATIVELY AS WELL, OF APPROXIMATELY 38 ¿ 40 MMHG. PATIENT WAS THEN PUT BACK ON PUMP AND REOPENED TO INTERROGATE THE VALVE. SUSPECT LEAFLET APPEARED TO OPEN WELL BUT NOT CLOSE ALL THE WAY UPON PROBING, BUT SUBSEQUENTLY SEEMED TO RESOLVE SOMEWHAT. PATIENT WAS THEN TAKEN OFF PUMP AGAIN WITH AN IMPROVED RESULT BUT STILL SOMEWHAT SUSPICIOUS LEAFLET MOTION AND GRADIENT OF ABOUT 20MMHG. SURGEON AND TEAM DECIDED TO CLOSE THE PATIENT AND EXPECT RECOVERY FROM OR MEDS/HYPO-CONTRACTILE HEART MIGHT RESOLVE THE SITUATION. THE TEAM WILL FOLLOW THIS PATIENT¿S ICU RECOVERY AND DETERMINE RESULTS ON FOLLOW-UP TO SEE IF THIS IS RESOLVED OR RESOLVES IN THE COMING DAY/S." LATEST UPDATE FROM SURGEON REPORTED THAT THE

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 21111763 ↗
• InjuryNov 1, 2024Perivalvular Leak; Perivalvular Leak

  ACCORDING TO INITIAL REPORTS, "AN EVENT WAS REPORTED BY THE SITE FOR PATIENT IN THE ON-X PAS STUDY. THIS EVENT OCCURRED ON (B)(6) 2023 AND IS REPORTED AS AN EXPLANT FOR PARAVALVULAR LEAK WITH AN END DATE OF 29APR2023 AND RECORDED AS FULLY RESOLVED. " PATIENT IMPACT - RE-DO SURGERY, HOSPITALIZATION. DATE OF ON-X IMPLANT - (B)(6) 2018 THIS EVENT IS RELEGATED TO ONXANE-23, SN (B)(6) FOR PARAVALVULAR LEAK AND EXPLANT.

  Patient problems: Valvular Insufficiency/ Regurgitation

  MAUDE report 20590166 ↗
• DeathFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SURGEON SUSPECTED DEATH BY PEA, PULSELESS ELECTRICAL ACTIVITY. FOLLOWING THE IMPLANT OF THIS DEVICE, NO DEFICIENCIES WERE NOTED. PATIENT LEFT THE OPERATING ROOM WITH NORMAL SINUS RHYTHM. APPROXIMATELY TWO AND A HALF HOURS LATER, THE PATIENT CRASHED ON ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION). RESUSCITATION AND IMAGING WERE PERFORMED BY THE SURGEON.

  Patient problems: Diminished Pulse Pressure

  MAUDE report 18789654 ↗
• InjurySep 20, 2023Perivalvular Leak; Perivalvular Leak

  ACCORDING TO THE INITIAL REPORT, AN AORTIC EIRC WAS RECEIVED FOR A PATIENT WITH AN EXISTING AORTIC VALVE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS DEVICE WAS EXPLANTED DUE TO PARAVALVULAR LEAK. THIS DEVICE WAS DISCARDED AT THE FACILITY. THE CURRENT STATUS OF THIS PATIENT IS CURRENTLY UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783535 ↗
• InjuryJul 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT AN IMPLANT REGISTRATION CARD (IRC)WAS RECEIVED FOR SN (B)(6) ONXACE-23 FOR A PATIENT WITH AN EXISTING ONXANE-23 IMPLANTED. ADDITIONAL INFORMATION FROM THE ARTIVION FIELD REPRESENTATIVE RELAYED "BASED ON MY CONVERSATION WITH THE FACILITY, THIS WAS NOT VALVE RELATED AND PATIENT IS DOING GREAT POST-OPERATIVELY!" ADDITIONAL INFORMATION PROVIDED BY THE ARTIVION FIELD REPRESENTATIVE COLLECTED FROM THE HOSPITAL RELAYED, THE ON-X VALVE WAS IMPLANTED DUE TO AORTIC STENOSIS AND ASCENDING AORTIC ANEURYSM. THE PATIENT IS A 60 YOWF WHO UNDERWENT AN ASCENDING AORTIC ANEURYSM REPAIR WITH AN AVR AND A CABG X 2 IN (B)(6) 2023. SHE DEVELOPED SUPERFICIAL DRAINAGE FROM HER STERNOTOMY INCISION WHICH REQUIRED ANTIBIOTICS BUT ULTIMATELY RESOLVED. SHE REPORTS DEVELOPING A TOOTH ABSCESS FOR WHICH SHE DID NOT SEEK MEDICAL CARE AROUND 2 WEEKS AFTER HER INITIAL HOSPITALIZATION FOR HER INITIAL SURGERY. SHE EVENTUALLY PRESENTED LAST WEEK (4 MONTHS AFTER HER INITIAL SURGERY) WITH SEVERE CHEST PAIN. AN OSH CT SHOWED A PERIAORTIC HEMATOMA. HER CRP AND WBC WERE ELEVATED ON ADMISSION HERE. DESPITE 1 WEEK OF IV ABX, HER CRP REMAINED ELEVATED. HER BCXS ERE[ARE] NEGATIVE, AND HER TEE SHO

  Patient problems: Pseudoaneurysm

  MAUDE report 17244390 ↗
• InjuryJul 1, 2023Adverse 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 ONXANE -23 SERIAL NUMBER: (B)(6) WAS EXPLANTED ON (B)(6) 2023. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE GONE UNMET. THIS INVESTIGATION IS RELEGATED TO ONXANE -23 SERIAL NUMBER: (B)(6).

  Patient problems: Insufficient Information

  MAUDE report 17244179 ↗
• InjuryOct 5, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT IS SUBJECT IN THE ON-X POST APPROVAL STUDY. ON (B)(6) 2022 WEAKNESS OF THE LEFT LEG AND HEADACHE. FELT SOME SENSATION ON LEFT SIDE YESTERDAY WITH HEADACHE. NO COLLAPSE OR HEAD INJURY. NO CHEST PAIN, SOB, NAUSEA, VOMITING OR ABDOMINAL PAIN, NO URINARY SYMPTOMS. PMHX MICRO-HAEMORRHAGE UNDER NEUROLOGY, STROKE (REPORTED BY PT), HEART VALVE REPLACEMENT. LIVES ALONE. SYMPTOMS ARE WORSENING OF CURRENT SYMPTOMS AND NOT NEW. UNDER NEURO FOR MICRO HAEMORRHAGES ADVISED D/C HOME. ADJUDICATION FORM RECEIVED. THIS EVENT IS RELATED TO THE PRODUCT. THIS INVESTIGATION IS RELEGATED TO ONXANE-23, (B)(4). EVENT DATE ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Headache; Stroke/CVA; Transient Ischemic Attack

  MAUDE report 15542254 ↗
• InjuryOct 4, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT IS SUBJECT IN THE ON-X POST APPROVAL STUDY. (B)(6) 2022 - PATIENT DEVELOPED A HEADACHE AND LEFT SIDED WEAKNESS. HE WAS SEEN BY STROKE CONSULTANT - WAS ALERT, NO FACIAL WEAKNESS, NO VISUAL FIELD LOSS. STUTTERING SPEECH IS NORMAL FOR HIM. MILD LEFT ARM DRIFT WHICH RESOLVED THE NEXT DAY. HE HAS BEEN SEEN BY PT/OT AND DISCHARGED WITH NO FURTHER NEEDS. WE STARTED BRIDGING THERAPY TO ENSURE INR WAS ABOVE 2 BEFORE DISCHARGING ON WARFARIN. INR ON DISCHARGE WAS 2. THE ANTI COAGULANT TEAM UPDATED US THAT THE TARGET INR HAS BEEN REDUCED TO 1.8 WITH A RANGE OF 1.5 TO 2. HE IS CURRENTLY WAITING A NEUROLOGY OUTPATIENT REVIEW. WE HELD STATIN DUE TO A RISE IN ALP - GP TO REPEAT BLOODS - LFTS STILL DERANGED FOR LIVER USS. HE IS MFFD. THIS EVENT IS RELEGATED TO ONXANE-23 5548916.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Headache; Stroke/CVA

  MAUDE report 15540235 ↗
• DeathJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT,"SUBJECT: AAP- 095 ON (B)(6) 2019 454 DAYS POST IMPLANT, SUBJECT EXPERIENCED A PERIPHERAL VASCULAR DISEASE WHICH RESULTED IN AXILLARY BI-FEMORAL BYPASS WITH BILATERAL FEMORAL ENDARTERECTOMY. AT TIME OF REINTERVENTION THE SUBJECTS INR WAS 1.1. ON (B)(6) 2020, THE SUBJECT EXPERIENCED AN ACUTE CVA AND WAS DIAGNOSED WITH LUNG CANCER WHICH RESULTED IN A READMISSION. DURING THEIR TIME IN THE HOSPITAL THE SUBJECT EXPERIENCED ACUTE RESPIRATORY FAILURE AND WENT INTO CARDIAC ARREST WHICH RESULTED IN DEATH ON (B)(6) 2014, 31 DAYS AFTER HOSPITALIZATION. SUBJECT IN THE POST MARKET STUDY: OX1901.000-M (11/20)- POST MARKET CLINICAL FOLLOW UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY. PI: [SURGEON]. WHILE ARTIVION REPRESENTATIVE WAS PERFORMING PAPER CRF REVIEW, ADVERSE EVENTS WERE DISCOVERED AS THEY WERE DOCUMENTED IN CRF SUBMITTED FOR STUDY. MEDICAL RECORDS/SOURCE DOCUMENTATION HAS NOT BEEN PROVIDED FOR REVIEW AND WILL NOT LIKELY BE OBTAINED. GIVEN THE RETROSPECTIVE NATURE, THESE EVENTS ARE NOT CURRENT. (STUDY TIMELINE IS 2008-2018). IDENTIFIED EVENTS WERE REPORTED TO FIELD ASSURANCE IN A PER SUBJECT REPORT.

  Patient problems: Cardiac Arrest; Respiratory Failure; Stroke/CVA

  MAUDE report 14744866 ↗
• InjuryMar 12, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ACCORDING TO IMPLANT REGISTRATION CARD RETURNED FROM THE USER FACILITY, ONXANE-23 SN (B)(4) WAS IMPLANTED (B)(6), 2022 IN A PATIENT WITH AN EXISTING ONXANE-23 SN (B)(4), (B)(6), 2020. BOTH IRCS NOTATE THE VALVES WERE IMPLANTED IN THE AORTIC POSITION. THIS INVESTIGATION WILL BE RELEGATED TO ONXANE- 23 SN (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 13742179 ↗
• InjuryAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED VIA EMAIL ON 04-AUG-2020 THE DEVICE TRACKING TEAM, THE PATIENT HAD AN ONXANE 23 SERIAL NUMBER (SN): (B)(4) IMPLANTED ON (B)(6) 2018. THIS VALVE WAS EXPLANTED ON (B)(6) 2020, AND REPLACED WITH ONXAAP 23 SN: (B)(4). ADDITIONAL INFORMATION FROM THE SURGEON'S OFFICE, (B)(6) YO M WITH PROSTHETIC VALVE ENDOCARDITIS, WITH N EF AND FEVERS ON ADM. ROOT ABSCESS ON TEE AND CT. DENTAL ABSCESS OR DENTAL WORK (NO ABX) IS SUSPECTED ETIOLOGY. THE VALVE (ONXANE 23) WAS COMPLETELY LOOSE AND ABLE TO BE PULLED OUT. CIRCUMFERENTIAL ABSCESS, DEBRIDED AND SOME OLD CLOT REMOVED. CULTURES WERE SENT AND ARE NEGATIVE SO FAR. THE ROOT WAS REPLACED AS BENTALL GIVEN THE ABSCESS/DESTRUCTION. PATIENT HX: EX-SMOKER, DYSLIPIDEMIA, ANEMIA, AKI, PREVIOUS AVR, RHEUMATIC FEVER AS CHILD AND DEVELOPED AI AND CHF THAT LEAD TO AVR ON (B)(6) 2018. NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Endocarditis

  MAUDE report 10454218 ↗
• MalfunctionMar 31, 2016Fracture; Fracture

  AS PER THE REQUEST SUBMITTED BY FDA MEDWATCH PROGRAM, THIS REPORT IS BEING RESUBMITTED AS REPORT NUMBER 1649833-2016--70018-1. THIS REPORT WAS INITIALLY SUBMITTED AS 1649833-2016-70014 - 1, MARCH 31, 2016. DESCRIPTION FROM MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MOR NO. 1649833-2016-70014. EVENT OCCURRED IN ROMANIA. A LEAFLET WAS BROKEN WHILE ATTEMPTING ROTATION OF THE VALVE. THE VALVE HAS BEEN RETURNED AND INVESTIGATED. EVIDENCE SUGGESTS THAT THE HOUSING WAS ROTATED EITHER BY AN UNDER SIZE ROTATOR OR OTHER METHOD OUTSIDE THE SCOPE OF THE VALVE INSTRUCTIONS FOR USE (IFU) RESULTING IN LEAFLET FRACTURE AND SUBSEQUENT VALVE HOUSING DAMAGE. IN BRIEF, IT IS SUMMARIZED AS "IATROGENIC DAMAGE". THE IFU CLEARLY WARNS AGAINST USING UNDERSIZE ROTATORS OR OTHER NON-ON-X INSTRUMENT AS IT CAN RESULT IN DAMAGE. THIS WAS NOT A STRUCTURAL VALVE DYSFUNCTION CAUSED BY LATENT DEFECT IN THE VALVE.

  Patient problems: Insufficient Information

  MAUDE report 5538828 ↗
• MalfunctionMar 10, 2016Fracture; Fracture

  DISTRIBUTOR IN (B)(4) REPORTED EVENT AS FOLLOWS: "ON (B)(6) 2016 DURING AN IMPLANT PROCEDURE, AT THE MOMENT WHEN THE PHYSICIAN TRIED TO ROTATE THE VALVE USING THE DEDICATED TOOL FROM THE KIT, THE VALVE DID NOT ROTATE BUT A LEAFLET BECAME DETACHED. THE VALVE WAS REPLACED WITH ANOTHER ONE IN ORDER TO CONTINUE THE SURGICAL PROCEDURE." THE VALVE IS BEING RETURNED FOR INVESTIGATION, HAS NOT YET ARRIVED. INVESTIGATIONS OF ALL SUCH INSTANCES OF CARBON PART DAMAGE HAVE BEEN CONCLUDED TO BE "IATROGENIC", USUALLY NOT FOLLOWING THE IFU WARNINGS. THIS IS THE EXPECTED CONCLUSION IN THIS CASE, BECAUSE USE OF THE CORRECT SIZE ROTATOR INSTRUMENT WILL NOT TRANSMIT ROTATIONAL FORCES TO THE LEAFLETS. AFTER THE INVESTIGATION IS COMPLETE, A FOLLOW-UP MDR WILL BE FILED.

  Patient problems: Iatrogenic Source

  MAUDE report 5491866 ↗

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