ONFLEX 0115610Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741095399), received between Dec 18, 2017 and Aug 5, 2025 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, THE MODIFIED ONFLEX MESH WAS NOTED TO BE RUPTURED BEFORE THE PROCEDURE. IT WAS REPORTED THAT THE INNER PACKAGING WAS FOUND TO BE INTACT, AND THE PRODUCT BOX WAS ALSO FULLY SEALED BEFORE IT WAS OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22721484 ↗
• InjuryJun 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL VENTRALEX ST ON (B)(6) 2021, MODIFIED ONFLEX ON (B)(6) 2023 AND 3DMAX MID ON (B)(6) 2024. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE DEVICES. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT.¿ IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 22165815 ↗
• MalfunctionAug 1, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A PROCEDURE, A FOREIGN MATERIAL (HAIR) WAS FOUND WHEN THE MODIFIED ONFLEX MESH PACKAGE WAS OPENED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19885942 ↗
• MalfunctionDec 27, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED ON (B)(6) 2022, UPON OPENING THE BARD/DAVOL MODIFIED ONFLEX MESH PACKAGE, A FOREIGN MATERIAL LIKE HAIR WAS FOUND. IT WAS REPORTED THAT ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16050668 ↗
• MalfunctionDec 1, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED ON 09-NOV-2022, UPON OPENING THE BARD/DAVOL MODIFIED ONFLEX MESH PACKAGE, A FOREIGN MATERIAL LIKE HAIR WAS FOUND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15893771 ↗
• MalfunctionDec 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, UPON OPENING THE PACKAGE OF THE BARD/DAVOL MODIFIED ONFLEX MESH ON 15-NOV-2021, IT WAS NOTED THAT THE SEALED EDGE WAS PEELED OFF ALL AROUND. AS REPORTED, NO DAMAGE WAS NOTED TO THE OUTER OR INNER PACKAGING. IT WAS REPORTED THAT THE MESH WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12955100 ↗
• InjuryJul 15, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, FOLLOWING IMPLANT OF A BARD/DAVOL MODIFIED ONFLEX MESH, THE PATIENT EXPERIENCED AN ALLERGIC REACTION AND DEVELOPED URTICARIA ON (B)(6) 2021. AS ALLEGED, THE PATIENT WAS SCHEDULED FOR A HOSPITAL VISIT ON (B)(6) 2021 AND THE MESH IS ALLEGEDLY SCHEDULED TO BE REMOVED ON (B)(6) 2021. ADDENDUM: AS REPORTED, THE PATIENT UNDERWENT REACTIVITY TESTING. AS REPORTED, THE PATIENT WAS ALLERGIC TO IODINE, NEGATIVE TO THE MESH AND SLIGHTLY ALLERGIC TO THE ABSORBABLE RING. IT WAS REPORTED THAT THE MESH REMOVAL WAS SCHEDULED ON (B)(6) 2021; THE SURGERY HAS BEEN POSTPONED (TIME UNDECIDED) BECAUSE THE PATIENT¿S ALLERGIC REACTION SYMPTOMS (URTICARIA, ETC.) IMPROVED BEFORE THE DATE. THE PATIENT IS UNDER OBSERVATION.

  Patient problems: Hypersensitivity/Allergic reaction; Urticaria

  MAUDE report 12177526 ↗
• InjuryDec 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL: ON (B)(6) 2017 - THE PATIENT WAS IMPLANTED WITH A BARD MODIFIED ONFLEX MESH. ON (B)(6) 2017 - THE PATIENT PRESENTED WITH ABDOMINAL WALL CELLULITIS AND RENAL FAILURE AND WAS TREATED WITH INFUSION AND MEDICATION. ON (B)(6) 2017 - THE PATIENT UNDERWENT EXPLANT OF THE MESH. THE RENAL FAILURE AND ABDOMINAL WALL FINDINGS (CELLULITIS) WERE RESOLVED FOLLOWING EXPLANT OF THE MESH AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AS REPORTED INITIALLY, ACUTE RENAL FAILURE BY CELLULITIS WAS SUSPECTED DUE TO CLINICAL FINDINGS. AT THAT TIME THE INFUSION WAS STARTED AND AFTER A BLOOD TEST AND EXPLANT OF THE MESH, AN ALLERGIC REACTION TO THE MESH WAS SUSPECTED.

  Patient problems: Cellulitis; Reaction; Renal Failure

  MAUDE report 7127621 ↗