On-X Ascending Aortic Prosthesis ONXAAP-23Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00851788001525), received between May 2, 2016 and Aug 15, 2025 — classified as 2 deaths, 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 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 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE MEDWATCH REPORT MW5148519 RECEIVED VIA EMAIL ON 12/18/2023 FROM THE FDA,"IT WAS LEARNED THAT A PATIENT WITH A NON-EDWARDS 23MM ON-X MECHANICAL VALVE DEVELOPED LARGE LVOT PSEUDOANEURYSM APPROXIMATELY 1 YEAR POST IMPLANT AND HAD EXTENSIVE TESTING, BUT NO CLEAR ETIOLOGY/MECHANISM FOR THE MECHANICAL VALVE FAILURE AND PRESUMED CULTURE NEGATIVE ENDOCARDITIS. SHE UNDERWENT REDO BIO BENTALL (B)(6) 2023) AND THE MECHANICAL VALVE WAS REPLACED WITH A 25MM EDWARDS AORTIC VALVED-CONDUIT. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). " ADDITIONAL INFORMATION TAKEN FROM THE MEDWATCH FORM INDICATED A ON-X AAP 23MM VALVE WAS EXPLANTED.

  Patient problems: Pseudoaneurysm

  MAUDE report 18518879 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "RECEIVED AN AORTIC IMPLANT REGISTRATION SN: (B)(6) ONXAAP-23 FOR A PATIENT WITH AN EXISTING AORTIC IMPLANT. PLEASE NOTIFY ME IF THIS IS ACTUALLY AN EXPLANT."

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 17505447 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SURGEON HAD FOUR PATIENTS RECENTLY THAT RECEIVED ONXAAPS END UP WITH INFECTIONS. TWO REQUIRED TAKE BACK TO THE OPERATING ROOM FOR WASHOUT DUE TO PERICARDIAL EFFUSIONS/MEDIASTINAL FLUID COLLECTIONS. SWABS WERE TAKEN OF THE MEDIASTINAL FLUID AND DID NOT GROW ANY ORGANISMS. ALL FOUR PATIENTS HAD ELEVATED WBC [WHITE BLOOD CELL] COUNTS. INDIUM NUCLEAR WBC SCAN WERE POSITIVE ON ALL FOUR WITH UPTAKE AROUND THE AORTA. THIS INVESTIGATION IS RELEGATED TO ONE OF THE FOUR PATIENTS WITH DATE OF IMPLANT: (B)(6), 2023.

  Patient problems: Endocarditis; Pericardial Effusion; Unspecified Infection

  MAUDE report 17350677 ↗
• InjuryFeb 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, PATIENT IN THIS STUDY EXPERIENCED ENDOCARDITIS WITH INFECTION ON (B)(6) 2022. SUBSEQUENTLY, THIS ON-X VALVE WAS EXPLANTED ON (B)(6) 2022.

  Patient problems: Endocarditis

  MAUDE report 16351226 ↗
• InjuryDec 15, 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 AAP STUDY - ASCEND - POST MARKET CLINICAL FOLLOW-UP STUDY IN PATIENTS TREATED WITH THE ON-X ASCENDING AORTIC PROSTHESIS (AAP) ADVERSE EVENT REPORT, EVENT DETAILS: IMPLANT DATE - (B)(6) 2021. PATIENT AGE AT TIME OF EVENT: 64 YO. ADVERSE EVENT CLASSIFICATION: THIS EVENT IS NOT LINKED TO THE MEDICAL DEVICE ¿ NON-SERIOUS (AE). DETAILED DESCRIPTION OF EVENT: NO INFORMATION PROVIDED. OUTCOME OF EVENT: NO INFORMATION PROVIDED. INFORMATION ON TAKEN ACTIONS BECAUSE OF EVENT: NO INFORMATION PROVIDED. ASSESSMENT BY INVESTIGATOR: NO INFORMATION PROVIDED. ADVERSE EVENT - CARDIAC ARRHYTHMIA. CLASSIFICATION ¿ ADVERSE EVENT. START DATE ¿ ((B)(6), 2021. END DATE ¿ (B)(6), 2021. DURATION OF EVENT ¿ 0. OUTCOME ¿ SYMPTOMS RESOLVED WITHOUT SEQUELAE. CAUSAL RELATIONSHIP TO THE PROCEDURE ¿ POSSIBLE. CAUSAL RELATIONSHIP TO THE AORTIC VALVE DISEASE OF HETEROGENEOUS ETHOLOGY ¿ POSSIBLE. CAUSAL RELATIONSHIP TO ON-X AAP ¿ POSSIBLE. NUMBER OF REOPERATIONS PERFORMED: 0. THIS INVESTIGATION IS RELEGATED TO ONXAAP-23 SN(B)(4).

  Patient problems: Arrhythmia; Atrial Fibrillation

  MAUDE report 15986517 ↗
• InjuryNov 9, 2022Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available; Insufficient Device Problem Information; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE ADVERSE EVENT REPORT, SERIOUS ADVERSE EVENT, LED TO A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT, USERS OR OTHER PERSONS AS DEFINED BY ONE OF THE FOLLOWING: MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. START DATE DECEMBER 6, 2019 END DATE DECEMBER 9, 2019 OUTCOME - SYMPTOMS RESOLVED WITHOUT SEQUELAE. CAUSAL RELATIONSHIP TO PROCEDURE - PROBABLE. CAUSAL RELATIONSHIP TO THE AORTIC VALVE DISEASE OF HETEROGENEOUS ETHOLOGY - NOT RELATED. CAUSAL RELATIONSHIP TO ON-X AAP - POSSIBLE. NUMBER OF REOPERATIONS PERFORMED: REOPERATION IS DEFINED AS AN ADDITIONAL SURGICAL PROCEDURE AFTER THE INDEX PROCEDURE (IMPLANTATION OF ON-X AAP) TARGETED AT THE PATHOLOGY THAT WAS INITIALLY TREATED USING THE ON-X AAP OR TARGETED AT A NEW PATHOLOGY CAUSED BY THE INDEX PROCEDURE - 1. COMMENT ON EVENT AND SPECIFY REASON IN CASE OF ADE OR SADE - NOT ADE OR SADE. DATE OF REOPERATION - DECEMBER 9, 2019. DAYS AFTER INTERVENTION - 3. MAIN REASON FOR REOPERATION - PPM IMPLANT. IS THE REASON FOR REOPERATION RELATED TO THE INTERVENTION - PROBABLE. IS THE REASON FOR THE REOPERATION RELATED TO THE AORT

  Patient problems: Arrhythmia; Heart Block; Unspecified Heart Problem

  MAUDE report 15765111 ↗
• DeathJul 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT DIED DUE TO A MASSIVE STROKE, RT MCA, AND CARE WAS WITHDRAWN. THIS PATIENT WAS IMPLANTED WITH ONXAAP-23 SN (B)(4) ON (B)(6) 2022 AND DIED ON (B)(6) 2022.

  Patient problems: Stroke/CVA

  MAUDE report 15136738 ↗
• InjuryJun 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SUBJECT: (B)(6) IN THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY, EXPERIENCED THE FOLLOWING EVENT: ON (B)(6) 2017, 9 DAYS POST IMPLANT, SUBJECT EXPERIENCED A HEART BLOCK WHICH RESULTED IN A PACEMAKER BEING IMPLANTED. AT TIME OF HOSPITALIZATION THE SUBJECTS INR WAS 3.2.

  Patient problems: Heart Block

  MAUDE report 14822936 ↗
• InjuryJun 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SUBJECT (B)(6) IN THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY, EXPERIENCED TWO ADVERSE EVENTS: ON (B)(6) 2015 8 DAYS POST IMPLANT, SUBJECT EXPERIENCED AFIB, HYPERTENSION AND DYSLIPIDEMIA LASTING 1 DAY. INR AT TIME OF HOSPITALIZATION WAS 2.2. NO FURTHER DETAILS WERE PROVIDED. ON (B)(6) 2015, THE SUBJECT EXPERIENCED PERICARDIAL EFFUSION WITH TAMPONADE AND PAROXYSMAL ATRIAL TACHYCARDIA. THE SUBJECT RECEIVED A PERICARDIAL WINDOW AND LEFT THORACOSTOMY TUBE AND WAS DISCHARGED 5 DAYS LATER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Atrial Fibrillation; Cardiac Tamponade; High Blood Pressure/ Hypertension; Pericardial Effusion; Tachycardia

  MAUDE report 14822843 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, SUBJECT AAP-094 IN THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY (STUDY TIMELINE 2008-2018) EXPERIENCED TWO ADVERSE EVENTS: ON (B)(6) 2018 190 DAYS POST IMPLANT, SUBJECT EXPERIENCED A SUPRAVENTRICULAR TACHYCARDIA WHICH RESULTED IN AN ABLATION. AT TIME OF REINTERVENTION THE SUBJECTS INR WAS 1.9. ON (B)(6) 2019, THE SUBJECT EXPERIENCED AN AORTIC ANEURYSM WHICH REQUIRED A REOPERATION FOR RESECTION OF AORTIC PSEUDOANEURYSM AND WAS DISCHARGED 4 DAYS LATER.

  Patient problems: Pseudoaneurysm; Tachycardia

  MAUDE report 14733724 ↗
• InjuryJun 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, SUBJECT (B)(6) IN THE AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY (STUDY TIMELINE IS 2008-2018) EXPERIENCED AN ACUTE RIGHT HEMISPHERIC ISCHEMIC STROKE AND SUPRAVENTRICULAR TACHYCARDIA ON (B)(6) 2015, 8 DAYS POST IMPLANT. THE SUBJECT¿S INR WAS 1.7 AT TIME OF HOSPITALIZATION.

  Patient problems: Ischemia Stroke; Tachycardia

  MAUDE report 14733140 ↗
• InjuryJun 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, SUBJECT IN THE ON-X ASCENDING AORTIC PROSTHESIS (AAP)- SINGLE SITE RETROSPECTIVE STUDY EXPERIENCED THE FOLLOWING EVENT: ON (B)(6) 2013 99 DAYS POST IMPLANT, SUBJECT EXPERIENCED A 10 DAY HOSPITALIZATION FOR A NON-ST-ELEVATION MYOCARDIAL INFARCTION. AT THE TIME OF THE HOSPITALIZATION THE SUBJECTS INTERNATIONAL NORMALIZED RATIO (INR) WAS 3.5. SUBJECT RECEIVED A HEART CATH (CATHETERIZATION) AND WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, THE SUBJECT HAD REOPERATION; CORONARY ARTERY BYPASS GRAFT SURGERY. NO FURTHER DETAILS OF THE EVENT WERE PROVIDED.

  Patient problems: Myocardial Infarction

  MAUDE report 14591655 ↗
• DeathMay 2, 2016Adverse Event Without Identified Device or Use Problem

  WHILE ENTERING DEVICE IMPLANT INFORMATION, IT WAS NECESSARY TO VERIFY THE PATIENT'S LAST NAME. IN AN INTERNET LOOK-UP, IT WAS LEARNED THE PATIENT HAD PASSED AWAY ON (B)(6) 2016. THE HOSPITAL WAS CONTACTED TO FIND OUT CAUSE OF DEATH. THE ORIGINAL SURGERY ON (B)(6) 2016 WAS FOR REPAIR OF A PSEUDO-ANEURISM. DURING THE SURGERY, THE ANEURISM RUPTURED. UPON ENTERING THE CHEST, THE PATIENT NEEDED TO BE MAINTAINED BY ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) AND COULD NOT BE WEANED FROM THE BYPASS. THIS CARE NEEDED A LOT OF STAFF AROUND THE CLOCK AND THE IMPLANTING LOCATION COULD NOT CONTINUE TO PROVIDE IT BECAUSE IT IS A SMALLER HOSPITAL. THE PATIENT WAS TRANSFERRED TO A LARGER (B)(6) FACILITY IN (B)(6) ON (B)(6) 2016, WHERE THE PATIENT PASSED AWAY ON SATURDAY (B)(6) 2016. ATTEMPTS WERE MADE TO GET INFORMATION AS TO CAUSE OF DEATH, WITH NO SUCCESS AS (B)(6) LAW HAS BARRIERS THAT INTERFERED WITH GETTING THIS INFORMATION. THIS IS BEING REPORTED IN THE EVENT IT IS ACTUALLY REPORTABLE, AND NOT DUE TO COMPLICATIONS OF THE SURGERY NOT DIRECTLY RELATED TO THE DEVICE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5624373 ↗

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