On-X Mitral Heart Valve with Standard Sewing Ring ONXM-27/29Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00851788001280), received between Aug 11, 2015 and Aug 15, 2024 — classified as 3 deaths, 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IMPLANT REGISTRATION CARD (IRC) FOR ONXMC-25/33 SN (B)(6), IMPLANT DATE (B)(6) 2024 RECEIVED BACK FROM THE USER FACILITY. THE DEVICE TRACKING DATABASE HAS AN EXISTING MITRAL VALVE FOR THIS PATIENT, ONXM-27/29 SN (B)(6), IMPLANT DATE (B)(6) 2024. THIS INVESTIGATION IS RELEGATED TO ONXM-27/29 SN (B)(6) FOR EXPLANT.

  Patient problems: Unspecified Heart Problem

  MAUDE report 19994524 ↗
• InjuryJan 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, THIS ONXM-27/29 SN (B)(6) WAS IMPLANTED ON (B)(6) 2021 IN WHICH A REDO PROCEDURE WAS PERFORMED.

  Patient problems: Insufficient Information; Thrombosis/Thrombus

  MAUDE report 16146327 ↗
• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE INITIAL REPORT, PATIENT RECEIVED ONXM 27/29 SN (B)(6) 1 ON (B)(6) 2016 WITH AN EXPLANT ON (B)(6) 2018. ACCORDING TO OPERATIVE NOTES, PATIENT EXPERIENCED ENDOCARDITIS, DEVELOPMENT OF A FISTULOUS TRACT AND AORTIC-MITRAL CURTAIN AND INTO THE RIGHT VENTRICLE.

  Patient problems: Endocarditis; Fistula

  MAUDE report 7953456 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARD RECEIVED INDICATE THAT PATIENT RECEIVED ONXM 27/29 ON (B)(6) 2014 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2014 AND REPLACEMENT WITH AN ONXM-25 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

  Patient problems: No Information

  MAUDE report 5995389 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARD RECEIVED INDICATE THAT PATIENT RECEIVED ONXM-27/29 ON (B)(6) 2009 WHICH REQUIRED INTERVENTION/EXPLANT ON 06/10/2015 AND REPLACEMENT WITH ANOTHER ONXM-27/29 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

  Patient problems: No Information

  MAUDE report 5995325 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANT RECOVERY CARD RECEIVED INDICATE THAT PATIENT RECEIVED ONXM-27/29 ON (B)(6) 2011 WHICH REQUIRED INTERVENTION/EXPLANT ON (B)(6) 2015 AND REPLACEMENT WITH ANOTHER ONXM-27/29 FOR UNSPECIFIED REASON. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE MADE WITHOUT SUCCESS.

  Patient problems: No Information

  MAUDE report 5995306 ↗
• InjuryOct 3, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, THE PATIENT RECEIVED ON-X MITRAL HEART VALVE WITH STANDARD SEWING RING - 27/29MM IN 2010. THE VALVE WAS EXPLANTED DUE TO UNKNOWN REASONS IN (B)(6) 2014 AND THE PATIENT RECEIVED ON-X MITRAL HEART VALVE WITH CONFORM-X SEWING RING - 25/33MM. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION, INCLUDING THE REASON FOR REOPERATION, OPERATIVE NOTES, AND PATIENT COMORBIDITES; HOWEVER, ALL ATTEMPTS WERE UNSUCCESSFUL.

  Patient problems: No Code Available

  MAUDE report 5995294 ↗
• DeathSep 29, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE IRC, PATIENT IMPLANTED WITH ONXM-27/29 ((B)(4)) ON (B)(6) 2016 AND DIED ON (B)(6) 2016.

  Patient problems: Death

  MAUDE report 5986478 ↗
• InjurySep 23, 2016Partial Blockage; Partial Blockage

  DR. (B)(6) OF (B)(6) HOSPITAL USED A M27/29 (SN (B)(4), EXPIRY DATE: 2020-02-10) TO PERFORM A MVR TWO WEEKS AGO. AFTER FINISHING THE SEWING, HE USED THE LEAFLET PROBE TO TEST THE MOVEMENT OF THE LEAFLETS. DR. (B)(6) SAID THERE WAS ONE LEAFLET NOT MOVING PROPERLY. HE USED THE ROTATOR TO TURN THE VALVE LEAFLETS TO ANOTHER POSITION, IT DID NOT IMPROVE THE LEAFLET MOVEMENT. DR. (B)(6) FINALLY DECIDED TO REMOVE THIS M 27/29 FROM PATIENT AND REPLACED BY ANOTHER ON-X M 27/29. THE MVR WAS COMPLETED WITHOUT AFFECTING THE QUALITY OF OPERATION. DR. (B)(6) COMPLAINED ABOUT THE QUALITY OF PRODUCT.

  Patient problems: No Code Available

  MAUDE report 5974825 ↗
• MalfunctionMar 30, 2016Fracture; Fracture

  AS PER THE REQUEST SUBMITTED BY FDA MEDWATCH PROGRAM, THIS REPORT IS BEING RESUBMITTED AS REPORT NUMBER 1649833-2016--70017-1. THIS REPORT WAS INITIALLY SUBMITTED AS FOLLOW-UP REPORT 1649833-2016-70030 - 1, MARCH 30, 2016. DESCRIPTION FROM MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MOR NO. 1649833-2015-70030. EVENT OCCURRED IN USA. ORIGINAL REPORT STATED LEAFLET BROKE WHILE ROTATING THE VALVE. THE VALVE HAS BEEN RETURNED AND INVESTIGATED AND IT WAS FOUND THAT THE LEAFLET HAD BEEN PUSHED OUT OF ITS SOCKET WHILE ATTEMPTING ROTATION, AND IN THE PROCESS THE HOUSING COATING WAS FRACTURED IN A NUMBER OF AREAS. THE CONCLUSION IS THAT THE DAMAGE RESULTED FROM USING A ROTATOR THAT IS SMALLER THAN THE VALVE SIZE, ALLOWING ROTATIONAL FORCES TO BE APPLIED TO THE LEAFLETS. THE CORRECT SIZE ROTATOR APPLIES ROTATIONAL FORCES SAFELY TO STRONG FEATURES ON THE HOUSING INTERIOR. IN BRIEF, IT IS SUMMARIZED AS "IATROGENIC DAMAGE". THE IFU CLEARLY WARNS AGAINST USING UNDERSIZED ROTATORS AS IT CAN RESULT IN DAMAGE. THIS WAS NOT A STRUCTURAL VALVE DYSFUNCTION CAUSED BY LATENT DEFECT IN THE VALVE.

  Patient problems: Insufficient Information

  MAUDE report 5536466 ↗
• MalfunctionNov 18, 2015Fracture

  LEAFLET BROKE WHILE HANDLING THE VALVE DURING IMPLANT ("WHILE ADJUSTING THE VALVE"), TAKEN TO MEAN WHILE ROTATING THE VALVE. PATIENT IS OK. THE PRODUCT HAS NOT YET BEEN RETURNED. THIS IS BEING REPORTED NOW BECAUSE CONCLUSIONS OF THE INVESTIGATION WILL NOT BE AVAILABLE PRIOR TO 30 DAYS. IN ALL PAST CASES OF CARBON PART BREAKAGE, THE CONCLUSION HAS BEEN "IATROGENIC", OR SURGEON-CAUSED, I.E., NOT A MALFUNCTION, OR STRUCTURAL VALVE DYSFUNCTION. IN ALL CASES WHERE LEAFLETS BREAK DURING ROTATION, IT HAS BEEN FOUND THAT THE ON-X ROTATOR INSTRUMENT WAS NOT USED. THE IFU HAS CLEAR WARNINGS ON USING ONLY ON-X INSTRUMENTS. ONCE WE COMPLETE THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5234157 ↗
• MalfunctionNov 6, 2015Mechanical Problem

  PATIENT RECEIVED A MITRAL VALVE REPLACEMENT (MVR) ON (B)(6) 2015. SUCCESSFULLY IMPLANTED AND TESTED THE VALVE, ALL SUCCESSFUL. AFTER CLOSURE, NOTED THAT HEART WAS BALLOONING, PUT PATIENT BACK ON BYPASS, FOUND THAT A LEAFLET WAS NOT MOVING PROPERLY. EXPLANTED THAT VALVE (ONXM-27/29) AND REPLACED WITH THE ONLY AVAILABLE VALVE, A SIZE 25MM. SURGEON REQUESTED THAT WE INVESTIGATE. NO OTHER INFORMATION AVAILABLE. SERIAL NUMBER NOT AVAILABLE. IT IS EXPECTED THAT THE VALVE WILL BE RETURNED FOR INVESTIGATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 5208358 ↗
• MalfunctionOct 24, 2015Obstruction of Flow

  MITRAL VALVE IMPLANT IN (B)(6). AFTER IMPLANT, LEAFLETS HAD DIFFICULTY MOVING. ATTEMPTED ROTATION, DID NOT HELP.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 5173364 ↗
• DeathAug 11, 2015Device remains implanted; Insufficient Device Problem Information

  Patient problems: Death; Hemorrhage, Cerebral

  MAUDE report 5001652 ↗
• DeathAug 11, 2015Device remains implanted; Insufficient Device Problem Information

  EVENT OCCURRED IN (B)(6). TENTH POST-OP DAY, PATIENT DEATH. JUDGED AS OPERATIVE MORTALITY, PROBABLY "SUDDEN". BACKGROUND: DOUBLE-VALVE PATIENT. DISEASE ETIOLOGY: ENDOCARDITIS. NYHA CLASS III. MITRAL REGURGITATION AND AORTIC REGURGITATION. EMERGENCY VALVE REPLACEMENT, AORTIC AND MITRAL. PATIENT NOT ON ANTICOAGULATION ON SURGERY DATE. ON JULY 21, 2015, ONXLTI RECEIVED A SET OF DATA FROM THE SPONSOR OF A (B)(4) STUDY, WHERE-IN THEY WANTED ON-X TO DO DATA ANALYSIS ON A SET OF DATA CONTAINING ADVERSE EVENTS. THE VALVE ON THIS MDR IS ONE OF THE AE'S. THERE ARE NO STATISTICALLY SIGNIFICANT DIFFERENCES IN THESE RATES AND THIS TRIAL WAS RUN AT INR OF 1.5 TO 2.5 VERSUS THE PMA AT 2.0 TO 3.0. AT LOWER INR LO RATES ARE EXPECTED BASED ON OUR RESEARCH. SO THESE EVENTS WHILE MDR REPORTABLE AS INDIVIDUAL OCCURRENCES, THEY ARE OVERALL IN THE RANGE EXPECTED.

  Patient problems: Death

  MAUDE report 5001650 ↗

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