On-X Ascending Aortic ProsthesisRecalls & reported problems across all models

We found 5 models of On-X Ascending Aortic Prosthesis by On-X Life Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 62 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2015 and Mar 2, 2026 — classified as 5 deaths, 57 injuries.

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

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported On-X Ascending Aortic Prosthesis problems

On-X Ascending Aortic Prosthesis models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• On-X Ascending Aortic Prosthesis ONXAAP-25

  Heart-Valve, Mechanical
  2 deaths25 reports
• On-X Ascending Aortic Prosthesis ONXAAP-23

  Heart-Valve, Mechanical
  2 deaths17 reports
• On-X Ascending Aortic Prosthesis ONXAAP-27/29

  Heart-Valve, Mechanical
  1 death12 reports
• On-X Ascending Aortic Prosthesis ONXAAP-21

  Heart-Valve, Mechanical
  6 reports
• On-X Ascending Aortic Prosthesis ONXAAP-19

  Heart-Valve, Mechanical
  2 reports

Recent On-X Ascending Aortic Prosthesis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2026Manufacturing, Packaging or Shipping Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION ON (B)(6) 2026, "DURING THE AAP IMPLANTATION THEY NOTICED THAT THE EXCESS TISSUE THAT WAS PREVENTING THE VALVE LEAFLETS FROM FUNCTIONING PROPERLY HAD NOT BEEN REMOVED, SO THE NEEDED TO CUT IT, NOT EASY TO DO ESPECIALLY IN A 19 MM DIAMETER, AND IT PROLONGED SURGERY BY ALMOST ONE HOUR." THIS INVESTIGATION IS RELEGATED TO ONXAAP-19, SN (B)(6) WITH ALLEGATION OF EXCESS MATERIAL PREVENTING VALVE LEAFLETS FROM FUNCTIONING PROPERLY. ADDITIONAL INFORMATION RECEIVED FROM REP 02/12/2026: "I HAVE A FEW MORE QUESTIONS FOR THE SURGEON REGARDING THIS EVENT: 1. IS THIS PICTURE EXACTLY WHAT THE SURGEON WAS LOOKING AT IN A UN-ALTERED ON-X AAP AS IT WAS SUPPLIED RIGHT FROM THE BOX AND INTO THE PATIENT? OR. 2. DID THE SURGEON CUT THE SUPPLIED VALSALVA GRAFT AWAY FROM THE ON-X SIZE 19MM VALVE AND THEN ATTEMPT TO SEW ON A DIFFERENT GRAFT? UNFORTUNATELY, YOUR FIRST OPTION."

  Patient problems: Insufficient Information

  MAUDE report 24483029 ↗
• InjuryAug 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, STUDY PATIENT EXPERIENCED A SERIOUS ADVERSE EVENT DESCRIBED AS "CHRONIC TYPE B DISSECTION" WHICH REQUIRED "REDO AORTIC ROOT REPLACEMENT." PROCEDURE (IMPLANT) DATE: ON (B)(6) 2022. EVENT ONSET DATE: 22MAY2025. EVENT END DATE: 12JUNE2025. THE EVENT WAS LISTED AS NOT RELATED TO THE PROCEDURE, POSSIBLY RELATED TO AORTIC VALVE DISEASE OF HETEROGENEOUS ETHOLOGY, AND POSSIBLY RELATED TO THE ON-X AAP DEVICE.

  Patient problems: Endocarditis; Insufficient Information; Pseudoaneurysm

  MAUDE report 22815253 ↗
• InjuryJun 6, 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 07MAY2025 FROM A HOSPITAL REPORT INDICATING THE ON-X VALVE HAD BEEN EXPLANTED. THIS INVESTIGATION IS RELEGATED TO ONXAPP 27/29 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF EXPLANT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22160818 ↗
• InjuryJun 6, 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 (B)(6) 2025 A HOSPITAL REPORT INDICATING THE ON-X VALVE HAD BEEN EXPLANTED. THIS INVESTIGATION IS RELEGATED TO ONXAPP 27/29 SERIAL NUMBER: (B)(6) WITH THE ALLEGATION OF EXPLANT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 22157877 ↗
• InjuryMay 13, 2025Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL REPORTS FROM (B)(6), PRODUCT TRACKING ASSOCIATE, ARTIVION, INC., "RECEIVED A HOSPITAL REPORT INDICATING IMPLANT HAD BEEN EXPLANTED AND REPLACED." ONXAAP-27/29 (B)(6). IMPLANT DATE (B)(6) 2024. EXPLANT DATE (B)(6) 2025. THIS INVESTIGATION IS RELEGATED TO ONXAAP-27/29, (B)(6) FOR EXPLANT. ADDITIONAL INFORMATION: PRE-OPERATIVE DIAGNOSIS 1. PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH LIKELY INFECTED ASCENDING DACRON GRAFT. 2. STATUS POST REDO STERNOTOMY AND DEBRIDEMENT OF PREVIOUS AORTIC VALVE REPLACEMENT WITH ROOT REPLACEMENT IN (B)(6) 2024. 3. STATUS POST AVR WITH TISSUE PROSTHESIS AS WELL AS MITRAL VALVE REPAIR WITH ANNULOPLASTY RING IN 2019. 4. DEVELOPMENT OF COMPLETE HEART BLOCK REQUIRING INSERTION OF A TEMPORARY PERMANENT PACING SYSTEM, LIKELY SECONDARY TO PROGRESSION OF ROOT ABSCESS. POST-OPERATIVE DIAGNOSIS 1. PROSTHETIC AORTIC VALVE ENDOCARDITIS WITH LIKELY INFECTED ASCENDING DACRON GRAFT. 2. STATUS POST REDO STERNOTOMY AND DEBRIDEMENT OF PREVIOUS AORTIC VALVE REPLACEMENT WITH ROOT REPLACEMENT IN (B)(6) 2024. 3. STATUS POST AVR WITH TISSUE PROSTHESIS AS WELL AS MITRAL VALVE REPAIR WITH AN ANNULOPLASTY RING IN 2019. 4. DEVELOPMENT OF COMPLETE HEART BLOCK REQU

  Patient problems: Endocarditis; Heart Block

  MAUDE report 22009531 ↗
• InjuryDec 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL EMAIL ON (B)(6) 2024, "ATTACHED YOU WILL FIND A NEW AE REGARDING ON-X AND THE ASCEND STUDY." SOURCE DOCUMENTATION STATES PATIENT IN THE ASCEND STUDY EXPERIENCED CARDIAC ARRYTHMIA THAT LED TO HOSPITALIZATION BEGINNING ON (B)(6) 2023 AND RESOLVING (B)(6) 2023.

  Patient problems: Arrhythmia

  MAUDE report 21035515 ↗
• InjuryNov 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT THE HOSPITAL REPORTED AN EXPLANT OF AN ON-X VALVE AND A REPLACEMENT IMPLANT OF AN ON-X VALVE FOR THE SAME PATIENT.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 20689131 ↗
• DeathSep 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT IN THE ASCEND STUDY PASSED AWAY ON (B)(6) 2023. THIS EVENT IS LISTED AS POSSIBLY RELATED TO THE PROCEDURE, DEVICE AND/OR AORTIC VALVE DISEASE.

  Patient problems: Insufficient Information

  MAUDE report 20339957 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INTIAL REPORT RECEIVED VIA EMAIL ON 25JULY2024 FROM ARTIVION HECHINGEN COMPLAINT MANAGER, (B)(4)., ASCEND STUDY PATIENT (B)(6) EXPERIENCED ENDOCARDITIS WITH INFECTION.

  Patient problems: Endocarditis

  MAUDE report 20047109 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INTIAL REPORT RECEIVED VIA EMAIL ON 25JULY2024 FROM ARTIVION HECHINGEN COMPLAINT MANAGER, (B)(4)., ASCEND STUDY PATIENT (B)(6) EXPERIENCED VALVE THROMBOSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20047056 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, PATIENT IS IN THE ASCEND STUDY, ¿THE FIRST WOUND REVISION WAS PERFORMED ON (B)(6) 2024 FOR A SUSPECTED STERNAL FISTULA. TWO WIRE CERCIAGES WERE REMOVED AND VAC THERAPY WAS INITIATED ON (B)(6), THE WOUND WAS CLOSED AGAIN.¿ ADDITIONAL INFORMATION RECEIVED 06/19/2024: ONXAAP-23, SN (B)(6). ADDITIONAL INFORMATION RECEIVED 06/21/2024: "PLEASE NOTE THAT SITE SURGEON HAS CALLED ME REGARDING THIS SAE. -HE TOLD ME THAT THE PATIENT WAS SHORT-TIME-HOSPITALIZED (ONE NIGHT) SEVERAL TIMES FOR THE TREATMENT OF THIS STERNAL FISTULA. -THE CASE WAS DISCUSSED VERY OFTEN BY THE PHYSICIANS AND THEY ASSUME THAT THE DEVICE WAS NOT INFECTED, BUT THEY CANNOT RULE IT OUT FOR 100%. THAT´S WHY DOCTOR EVALUATED THE RELATION TO THE DEVICE AS POSSIBLE. HE WANTED TO ADD MORE DETAILS IN THE COMMENT FIELD OF THE AE-FORM, BUT IT WAS TOO SHORT. -THE PATIENT IS DOING FINE AGAIN NOW BUT THEY WILL FOLLOW-UP ON TH.IS EVENT ONE MORE TIME. THE SOURCE DATA OF THIS FOLLOW-UP WILL BE SENT AGAIN, IF NECESSARY."

  Patient problems: Fistula

  MAUDE report 19594695 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION , "PATIENT IS IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2011 WITH AN AAP DEVICE WITH AN UNKNOWN SN. THIS SUBJECT EXPERIENCED ADVERSE EVENT DURING THE DATES OF DATA COLLECTION [IMPLANT TO (B)(6) 2021 THAT WERE REPORTED TO THE SPONSOR. BELOW IS A SUMMARY OF EACH EVENT: ON (B)(6) 2012 : DIAGNOSIS OF ATRIAL FLUTTER WITH RVR WITH CARDIOVERSION ON (B)(6) 2012 ADJUDICATED AS : PROBABLY VALVE RELATED, PROBABLY PROCEDURE RELATED AND NOT ANTICOAGULATION RELATED. LIMITED INFORMATION WAS PROVIDED AS THIS WAS A RETROSPECTIVE STUDY, ALL AVAILABLE INFORMATION WILL BE SUBMITTED WITH THIS REPORT." THIS COMPLAINT INVESTIGATION IS RELEGATED TO THE ON 23JAN2012 EVENT FOR ONXAAP-23, SN (B)(6).

  Patient problems: Atrial Flutter

  MAUDE report 18640865 ↗
• InjuryFeb 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION "PATIENT IS IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2011 WITH AN AAP DEVICE WITH AN UNKNOWN SN. THIS SUBJECT EXPERIENCED ADVERSE EVENT DURING THE DATES OF DATA COLLECTION [IMPLANT TO (B)(6) 2021] THAT WERE REPORTED TO THE SPONSOR. BELOW IS A SUMMARY OF EACH EVENT: 22DEC2011 : DIAGNOSIS OF HEART BLOCK ADJUDICATED AS : PROBABLY VALVE RELATED, PROBABLY PROCEDURE RELATED AND NOT ANTICOAGULATION RELATED. LIMITED INFORMATION WAS PROVIDED AS THIS WAS A RETROSPECTIVE STUDY, ALL AVAILABLE INFORMATION WILL BE SUBMITTED WITH THIS REPORT." THIS COMPLAINT INVESTIGATION IS RELEGATED TO THE 22DEC2011 EVENT FOR ONXAAP-23, SN (B)(6).

  Patient problems: Heart Block

  MAUDE report 18640759 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL NOTIFICATION "PATIENT IS IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2018 WITH A PREFABRICATED AAP DEVICE SN (B)(6). ON (B)(6) 2018 (1 DAY POST IMPLANT) WAS NOTED WITH MINIMAL RESPONSE AFTER SURGERY. THE SUBJECT¿S RELEVANT HISTORY IS AS FOLLOWS. THE SUBJECT HAS BEEN PREVIOUSLY ADMITTED IN (B)(6) 2018 DUE TO ISCHEMIC STROKE IN THE RIGHT CEREBELLUM DUE TO EMBOLISM FROM THROMBOSIS OF A MECHANICAL AORTIC VALVE. HE WAS DISCHARGED TO REHAB AND THEN READMITTED ON (B)(6) 2018. AN MRI PERFORMED ON (B)(6) 2018 SHOWED MULTIPLE NEW FOCI OF DIFFUSION RESTRICTION INTRACRANIALLY IN BOTH HEMISPHERES COMPATIBLE WITH NEW INTERVAL EMBOLIC PHENOMENON COMPARED TO (B)(6) 2018 STUDY. A TEE WAS PERFORMED (DATE UNKNOWN) SHOWING ANNULAR THROMBOSIS AND UNROOFING WITH A MOBILE MASS WITH A THIN STALK IN THE LVOT COMING FROM THE ANNULUS. THE RE-DO AORTIC VALVE REPAIR WITH ASCENDING AORTIC REPLACEMENT WAS DONE ON (B)(6) 2018. ON (B)(6) 2018 A REPEAT MRI WAS PERFORMED SHOWING SMALL PROBABLE ACUTE ISCHEMIC FOCUS INVOLVING POSTERIOR RIGHT OCCIPITAL LOBE THAT WAS NOT VISUALIZED ON PRIOR CT OR M

  Patient problems: Stroke/CVA; Thrombosis/Thrombus

  MAUDE report 18594851 ↗
• InjuryJan 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO INITIAL NOTIFICATION "PATIENT IS IN THE POST-MARKET CLINICAL FOLLOW-UP STUDY PROTOCOL OF THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) RETROSPECTIVE STUDY AND WAS IMPLANTED ON (B)(6) 2014 WITH A PREFABRICATED AAP DEVICE SN (B)(6). ON (B)(6) 2018 (1,324 DAYS POST IMPLANT) AND PRESENTED TO THE ED FROM WORK WHERE HE EXPERIENCED DIFFICULTY FORMING WORDS, SLURRED SPEECH, RIGHT SIDED HEADACHE AND LEFT FACIAL DROOP. ALL SYMPTOMS HAD RESOLVED QUICKY PRIOR TO ARRIVING TO THE ED, EXCEPT LIGHT HEADINESS AND DIZZINESS. HE WAS ADMITTED FOR OBSERVATION AND FURTHER TESTING. AN MRI WAS PERFORMED SHOWING ACUTE INFARCT INVOLVING THE INSULAR CORTEX EXTENDING TO INVOLVE THE SUPERIOR LONGITUDINAL FASCICULAR ON THE RIGHT. THE CT AND CTA OF THE HEAD WERE UNREMARKABLE, THE CAROTID DOPPLER WAS UNREMARKABLE. INR WAS 2.0 ON ADMISSION. PT WAS EVALUATED BY PT/OT/ST AND DISCHARGED HOME ON (B)(6) 2018 AFTER ADDING ASA TO HIS DAILY MEDICATION TO FOLLOW UP WITH CARDIOLOGIST AND NEUROLOGIST." THIS COMPLAINT IS ASSOCIATED WITH ONXAAP-25 SN (B)(6).

  Patient problems: Stroke/CVA

  MAUDE report 18594801 ↗

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