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

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00851788001396), received between Oct 3, 2016 and Mar 9, 2026 — classified as 1 death, 3 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 9, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE MEDWATCH FORM RECEIVED VIA EMAIL FROM THE FDA MEDICAL DEVICE REPORTING TEAM ON 02/11/2026, ¿DESCRIBE THE EVENT OR PROBLEM: AFTER SECURING THE COR-KNOTS, THE SURGEON ATTEMPTED TO CUT OUT THE VALVE HOLDER, HOWEVER IT DID NOT DISLODGE. THE SUTURE OF THE VALVE HOLDER WAS CUT AND HANDLE WAS REMOVED, BUT VALVE WOULD STILL NOT COME OUT. THERE WAS CONCERN THE VALVE HAD BECOME DAMAGED WHEN TRYING TO REMOVE THE HOLDER. A STERNOTOMY WAS PERFORMED AND THE VALVE WAS REMOVED AND REPLACED WITH A DIFFERENT VALVE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : MINIMALLY INVASIVE AORTIC VALVE REPLACEMENT, USING RIGHT MINI THORACOTOMY APPROACH WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING)¿. FDA MEDWATCH FORM 3500A MEDSUN REPORT NUMBER: (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24544121 ↗
• DeathSep 16, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ON SEPTEMBER 1, 2022 THE FDA FORWARDED A MEDWATCH REPORT (B)(4) WHICH WAS SUBMITTED BY THE USER FACILITY IDENTIFYING AN ARTIVION PRODUCT. ACCORDING TO THE REPORT, "PATIENT HAD AN AORTIC VALVE REPLACEMENT WITH USAGE OF A MECHANICAL VALVE. SURGERY WITHOUT COMPLICATIONS. PATIENT DIED SEVERAL DAYS LATER AT HOME." THE PROCEDURE WAS REPORTED AS "AORTIC VALVE REPLACEMENT WITH LEFT ATRIAL APPENDAGE LIGATION." ADDITIONAL INFORMATION REPORTED STATES: "INR ONLY GOT AS HIGH AS 1.2 BEFORE PATIENT DIED." THE PATIENT WAS IDENTIFIED AS A 47-YEAR OLD FEMALE, WEIGHING 221 LBS., WITH THE FOLLOWING PRE-EXISTING CONDITIONS: "DIABETES; HYPERTENSION; MORBIDLY OBESE." ADDITIONAL INFORMATION WAS RECEIVED ON 9/7/2022: "THE PATIENT'S NATIVE VALVE WAS REPLACED WITH AN ONX VALVE. THE CAUSE OF DEATH IS UNKNOWN AND THE FAMILY REFUSED AN AUTOPSY. THE RECORDS [MEDICAL RECORDS, OPERATIVE NOTES, RE-OPERATIVE NOTES] ARE NOT BEING RELEASED."

  Patient problems: Insufficient Information

  MAUDE report 15438793 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT RECEIVED, A (B)(6) FEMALE THAT HAD AN ON-X AORTIC VALVE IMPLANTED ON (B)(6) 2019 SUFFERED A STROKE IN (B)(6) 2022 AND INR WAS INCREASED TO 3.8. HOME MONITORING WAS SUGGESTED. PATIENT IS ALSO DOING PHYSICAL AND SPEECH THERAPY. INR RECORDS SHOWED RANGE OF LOW (1.2 IN MARCH 2022) TO AN AVERAGE OF ABOUT 2.1.

  Patient problems: Stroke/CVA

  MAUDE report 14574916 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARDS RECEIVED INDICATED THAT PATIENT RECEIVED ONXAE-23 ON (B)(6) 2011 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2014 AND REPLACEMENT WITH ONXAE-21 FOR UNSPECIFIED REASON. ADDITIONAL INFORMATION RECEIVED VIA PHONE CONVERSATION ON (B)(6) 2016 WITH THE NURSE INDICATED THAT THE PATIENT WAS NOW DECEASED AND NO INFORMATION WOULD BE RELEASED FOR THE PATIENT.

  Patient problems: Death; No Information

  MAUDE report 5995223 ↗

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