On-X Ascending Aortic Prosthesis ONXAAP-27/29Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00851788001549), received between Oct 24, 2022 and Jun 6, 2025 — classified as 1 death, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 17350622 ↗
• InjuryApr 26, 2023Insufficient Device Problem Information; 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, PATIENT EXPERIENCED MAJOR BLEEDING EVENT (B)(6) 2023. DATE OF IMPLANT: (B)(6) 2023. 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 BODY FUNCTION. START DATE: (B)(6) 2023. END DATE: (B)(6) 2023. SYMPTOMS RESOLVED WITHOUT SEQUELAE. CAUSAL RELATIONSHIP TO PROCEDURE: CAUSAL. CAUSAL RELATIONSHIP TO THE AORTIC VALVE DISEASE OF HETEROGENEOUS ETHOLOGY: NOT RELATED. CAUSAL RELATIONSHIP TO ONXAAP: POSSIBLE. NUMBER OF REOPERATIONS PERFORMED: 1.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16818120 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, PATIENT IN THE STUDY EXPERIENCED CARDIAC ARRHYTHMIA ON (B)(6) 2020, FOLLOWING IMPLANT WITH THE ONXAAP (IMPLANTED (B)(6) 2020).

  Patient problems: Arrhythmia

  MAUDE report 16496304 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, A PATIENT IN THE ASCEND STUDY WAS REPORTED TO HAVE A CARDIAC ARRHYTHMIA (III GRADE AV BLOCK) THAT RESULTED IN A REOPERATION. THIS INVESTIGATION WILL BE RELEGATED TO ONXAAP-27/29, SN (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: Heart Block

  MAUDE report 16364384 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (B)(6) IN THE ASCEND STUDY EXPERIENCED THREE (3) ADVERSE EVENTS THAT WERE POSSIBLY RELATED TO THE IMPLANTED ON-X VALVE [ONXAAP-27 /27 SN (B)(4)]: (B)(6) 2022: SEIZURE. (B)(6) 2022: CARDIAC ARRHYTHMIA. (B)(6) 2022: MEDIASTINAL HEMATOMA OVERLYING THE RIGHT VENTRICLE WITH COMPRESSION. THIS INVESTIGATION WILL BE RELEGATED TO THE (B)(6) 2022 EVENT.

  Patient problems: Hematoma; Pleural Effusion; Shock

  MAUDE report 15960829 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT: (B)(6) IN THE ASCEND STUDY EXPERIENCED THREE (3) ADVERSE EVENTS THAT WERE POSSIBLY RELATED TO THE IMPLANTED ON-X VALVE [ONXAAP-27/27 SN: (B)(4)]: ON (B)(6) 2022: SEIZURE. ON (B)(6) 2022: CARDIAC ARRHYTHMIA. ON (B)(6) 2022: MEDIASTINAL HEMATOMA OVERLYING THE RIGHT VENTRICLE WITH COMPRESSION. THIS INVESTIGATION WILL BE RELEGATED TO THE ON (B)(6) 2022 EVENT.

  Patient problems: Arrhythmia

  MAUDE report 15960683 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT (B)(6) IN THE ASCEND STUDY EXPERIENCED THREE (3) ADVERSE EVENTS THAT WERE POSSIBLY RELATED TO THE IMPLANTED ON-X VALVE [ONXAAP-27/27 SN (B)(4)]: (B)(6) 2022: SEIZURE; (B)(6) 2022: CARDIAC ARRHYTHMIA; (B)(6) 2022: MEDIASTINAL HEMATOMA OVERLYING THE RIGHT VENTRICLE WITH COMPRESSION. THIS INVESTIGATION WILL BE RELEGATED TO THE (B)(6) 2022 EVENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 15960113 ↗
• InjuryOct 24, 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 INITIAL REPORTS, ASCEND - POST MARKET CLINICAL FOLLOW-UP STUDY IN PATIENTS TREATED WITH THE ON-X ASCENDING AORTIC PROSTHESIS (AAP). ADVERSE EVENT - PATIENT EXPERIENCED CARDIAC ARRHYTHMIA. DURATION OF THE EVENT (B)(6) 2020. SYMPTOMS RESOLVED WITHOUT SEQUELAE. CAUSAL RELATIONSHIP TO PROCEDURE - POSSIBLE. CAUSAL RELATIONSHIP TO THE AORTIC VALVE DISEASE OF HETEROGENEOUS ETHOLOGY - NOT RELATED. CAUSAL RELATIONSHIP TO ONXAAP - POSSIBLE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Arrhythmia

  MAUDE report 15657553 ↗

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