On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder ONXANE-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851788001655), received between Oct 3, 2016 and Mar 4, 2024 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL NOTIFICATION ON 02/22/2024, "RECEIVED IRC WITH ¿IMPLANTED/EXPLANTED¿ WRITTEN ON CARD." ADDITIONAL INFORMATION RECEIVED FROM REP 02/28/2024: "THE VALVE WAS EXPLANTED BECAUSE AFTER PLACEMENT THE PATIENT HAD A LARGE PERIVALVULAR LEAK FROM A ROOT ABSCESS. AFTER THE VALVE WAS REMOVED, A HAD TO DO A ROOT REPLACEMENT."

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

  MAUDE report 18831385 ↗
• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, "I RECEIVED A CALL TODAY FROM A SURGEON AT [HOSPITAL] STATING A PATIENT IS HAVING HEMOLYSIS AND HE (THE PATIENT) THINKS IT¿S BECAUSE OF THE ON-X HEART VALVE." ADDITIONAL INFORMATION WAS PROVIDED: 1. PRODUCT CODE AND SERIAL NUMBER OF THE VALVE? PROSTHESIS INSTALLED: ITEM: VALVE, IMPLANT STERILITY CHECKED (Y/N): YES, STERILITY EXPIRATION DATE: JAN 17, 2024, RN VERIFIER: [XXX], VENDOR: ON-X LIFE TECHNOLOGIES, INC., MODEL: ONXANE, LOT NUMBER: NONE, SERIAL NUMBER: (B)(4), STERILE RESP: MANUFACTURER, SIZE: 21MM. 2. INITIAL DATE OF SURGERY? (B)(6) 2018. 3. REASON FOR IMPLANTATION OF VALVE? SEVERE AORTIC INSUFFICIENCY. 4. DATE THE HEMOLYSIS WAS DIAGNOSED? UNKNOWN. 5. ACTION TAKEN BY SURGEON TO ADDRESS THE HEMOLYSIS? NONE. 6. HOW IS THE PATIENT CURRENTLY DOING? STILL GETTING PERIODIC IRON TRANSFUSIONS. 7. ARE OPERATIVE NOTES AVAILABLE FOR REVIEW? NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Anemia

  MAUDE report 12307950 ↗
• DeathJun 26, 2020Adverse 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 REPORT ONXANE 21 SN: (B)(4) WAS IMPLANTED ON (B)(6) 2020. AN OBITUARY FOR THE PATIENT WAS FOUND WITH DATE OF DEATH AS (B)(6) 2020. THIS INVESTIGATION IS RELEGATED TO ONXANE 21 SN: (B)(4). NO ADDITIONAL INFORMATION FORTHCOMING.

  Patient problems: Death

  MAUDE report 10201515 ↗
• DeathOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARD (IRC) RECEIVED INDICATES THAT PATIENT UNDERWENT DOUBLE VALVE SURGERY ON (B)(6) 2016 RECEIVING ONXANE-21 AND ONXM-25 INDICATED FOR SEVERE AORTIC INSUFFICIENCY AND SEVERE MITRAL REGURGITATION. PROCEDURE PERFORMED WAS "TRANSESOPHAGEAL ECHOCARDIOGRAM [TEE], MITRAL VALVE REPLACEMENT, CHORDAL SPARING (25 MM ON-X MECHANICAL VALVE), AORTIC VALVE REPLACEMENT (21 MM ON-X MECHANICAL VALVE), EXTENSIVE PERICARDIAL ADHESIOLYSIS SECONDARY TO EXTENSIVE PERICARDITIS." ADDITIONAL INFORMATION RECEIVED INDICATED THAT PATIENT DIED ON (B)(6) 2016. A PRELIMINARY AUTOPSY REPORT INDICATES THE FOLLOWING: PROVISIONAL ANATOMIC DIAGNOSES: CARDIOVASCULAR SYSTEM: STATUS POST (B)(6) 2016 AORTIC VALVE & RNLTRAL VALVE REPLACEMENT SURGERY; BOTH MITRAL AND AORTIC ON-X PROSTHETIC HEART VALVES APPEAR PROPERLY POSITIONED AND INTACT; SMALL EPICARDLAL ABSCESS (1 CM) AD]ACENT TO PROSTHETIC MLTRAL VALVE B, HEART WITH CARDLOMEGALY (569 G); LEFT VENTRICULAR HYPERTROPHY; FOCAL SCARRING OF MYOMETRLUM SUGGESTIVE OF REMOTE INFARCT; NO ACUTE INFARCTION SEEN; FLBRLNOUS PERLCARDITIS; CALCFFLC ATHEROSCLEROSIS OF CORONARY ARTERIES. PULMONARY SYSTEM: CONGESTED APPEARS TO LUNGS ,BILATERALLY (EACH LUNG 720 G); NO EV

  Patient problems: Death

  MAUDE report 5995430 ↗

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