ONFLEX 0115410Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741074424), received between Apr 11, 2018 and Jul 15, 2025 — classified as 6 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER JOURNAL ARTICLE: "TRANS RECTUS SHEATH EXTRA-PERITONEAL PROCEDURE (TREPP) FOR INGUINAL HERNIA REPAIR UNDER LOCAL ANESTHESIA WITH SEDATION IN THE OUTPATIENT CLINIC: A FEASIBILITY STUDY." THE ARTICLE DESCRIBES RETROSPECTIVE FEASIBILITY STUDY WHICH INVESTIGATES THE SAFETY AND EFFICIENCY OF TREPP UNDER LOCAL ANESTHESIA IN THE OUTPATIENT CLINIC IN COMPARISON WITH LICHTENSTEIN BETWEEN 2019 AND 2022. IT WAS PERFORMED EXAMINING 247 PATIENTS (34 PATIENTS IN THE TREPP GROUP AND 213 PATIENTS IN THE LICHTENSTEIN GROUP) WHO UNDERWENT AN ELECTIVE INGUINAL HERNIA REPAIR UNDER LOCAL ANESTHESIA IN THE OUTPATIENT CLINIC OPERATION THEATRE. THE FOLLOWING COMPLICATIONS WAS OBSERVED DURING INGUINAL HERNIA REPAIR FOR TREPP GROUP PATIENTS TREATED WITH ONFLEX MESH HAD INGUINAL HERNIA RECURRENCE WITHIN 8 WEEKS OCCURRED 1 TIME IN THE TREPP GROUP. A SUB-ANALYSIS ON 6-MONTHS RECURRENCE RATE SHOWED 2 HERNIA RECURRENCES IN THE TREPP GROUP, THIS INCLUDES THE RECURRENCE WITHIN 8 WEEKS IN BOTH GROUPS. PAIN WAS PRESENT AFTER 8 WEEKS POST-OPERATIVELY IN (N=3) 8.8% OF THE PATIENTS IN THE TREPP GROUP. WOUND INFECTION, TREPP, N=1(2.9%); HEMATOMA, TREPP, N=5(14.7%); SEROMA, TREPP N=1(2.9%). THE ARTICLE CONCLUDED THAT

  Patient problems: Hematoma; Hernia; Pain; Post Operative Wound Infection; Seroma

  MAUDE report 22510949 ↗
• MalfunctionJun 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE, ONFLEX MESH EDGE WAS COMING LOOSE. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22184488 ↗
• MalfunctionJun 4, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ONFLEX MESH CONTAMINATED WITH FOREIGN MATTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459765 ↗
• MalfunctionDec 19, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING ATTEMPTED IMPLANTATION OF AN ONFLEX MESH, IT WAS NOTED THAT THE ¿RIM WAS GETTING LOOSE¿ AS SUCH ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. CONTACT REPORTS A CLAMP WAS ATTACHED TO THE MESH TO INSERT AND IS UNSURE IF THE CLAMP DAMAGED THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18354502 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  PER JOURNAL ARTICLE IN HERNIA (2021) TITLED, ¿SAFETY AND EFFICACY IN INGUINAL HERNIA REPAIR: A RETROSPECTIVE STUDY COMPARING TREPP, TEP AND LICHTENSTEIN (SETTLE).¿ FEATURED WAS A RETROSPECTIVE COHORT STUDY, 300 PATIENTS OF WHICH 58 (19.3%) UNDERWENT TREPP, 190 (63.3%) TEP AND 52 (17.3%) LICHTENSTEIN WITH BARD/DAVOL ONFLEX, NON-BARD/DAVOL PARIETEX, NON-BARD/DAVOL BIOMESH RESPECTIVELY OVER A PERIOD OF 7 MONTHS FROM MARCH TO SEPTEMBER 2019. THE PRIMARY OUTCOME OF THIS STUDY WAS INGUINAL HERNIA RECURRENCE RATE WITHIN 1 YEAR AFTER SURGERY. SECONDARY OBJECTIVES WERE CHRONIC POST-OPERATIVE INGUINAL PAIN (CPIP) LASTING MORE THAN 6 MONTHS, (MAJOR) COMPLICATION RATES AND OPERATING TIME. THE FOLLOWING COMPLICATIONS WERE OBSERVED FROM 58 PATIENTS TREATED WITH ONFLEX MESH DURING TREPP INGUINAL HERNIA REPAIR: RECURRENCE 2 (1.7%) PATIENTS; CHRONIC PAIN (>6 MONTHS) 1 (1.7%) PATIENT; HEMATOMA (SURGICAL EVACUATION) 5 (8.6%) PATIENTS & WOUND INFECTION 4 (6.9%) PATIENTS. INFORMATION IS PRESENTED WITHOUT PATIENT/CASE SPECIFIC DETAILS.

  Patient problems: Hematoma; Hernia; Pain; Post Operative Wound Infection

  MAUDE report 15978190 ↗
• InjuryOct 12, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  AS ALLEGED, THE PATIENT WAS IMPLANTED WITH A BARD/DAVOL ONFLEX MESH. IT WAS REPORTED THAT THE SURGERY TOOK PLACE "TWO YEARS AGO". IT IS ALLEGED THAT THE PATIENT HAS HAD PAIN SINCE SURGERY AND ALLEGEDLY AN MRI SHOWS THE MESH HAS MIGRATED AND IS DAMAGING OTHER AREAS OF THE BODY. AS REPORTED, "THE MESH WILL PROBABLY BE REMOVED AS IT SEEMS TO BE HURTING HIS NERVES AND ONE TESTICLE." AS REPORTED, THE PATIENT'S DOCTOR HAS PROPOSED TO RE-OPERATE. IT IS REPORTED THAT THE PATIENT WANTS TO CONTINUE IN THE PAIN CLINIC AT THIS TIME AND DOES NOT WANT TO UNDERGO RE-OPERATION.

  Patient problems: Nerve Damage; Pain

  MAUDE report 12617287 ↗
• InjuryNov 3, 2020Defective Device; Patient-Device Incompatibility; Material Deformation; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD MESH (BARD FLAT MESH) AND BARD ONFLEX MESH MEDIUM ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF ONFLEX (DEVICE #2). PER OP NOTES, "NO DIRECT HERNIA DEFECT WAS IDENTIFIED. THE INTERNAL INGUINAL RING WAS SLIGHTLY ENLARGED. THE INGUINAL CANAL FLOOR WAS RECONSTRUCTED WITH ONFLEX (DEVICE #2). NOTE, THERE WAS NO MENTION OF BARD FLAT MESH (DEVICE #1) BEING IMPLANTED IN THIS PROCEDURE. (NOTE: THERE WAS NO INDICATION IN THE MEDICAL RECORDS PROVIDED THAT THE PATIENT WAS IMPLANTED WITH A BARD FLAT MESH.) (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH CHRONIC PAIN, RIGHT INGUINAL NEURALGIA WITH MESHOMA, NERVE ENTRAPMENT THEREBY UNDERWENT WITH REMOVAL OF PARTIAL MESH (DEVICE #1). PER OP NOTES, "THERE W

  Patient problems: Adhesion(s); Injury; Nerve Damage

  MAUDE report 10779601 ↗
• InjuryFeb 21, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2020 THE PATIENT UNDERWENT THE REPAIR OF A SMALL FEMORAL HERNIA AND WAS IMPLANTED WITH A MEDIUM BARD ONFLEX MESH IN THE PREPERITONEAL SPACE. THE MESH WAS FIXATED WITH PROLENE STITCHES AT THE SUPERIOR LATERAL ASPECT. AS REPORTED THE PATIENT IS A "SKINNY SHORT LADY" AND UPON PLACEMENT THE SURGEON FELT THE CHOSEN MESH WAS TOO BIG FOR THE PATIENT'S BODY HABITUS. ON (B)(6) 2020 THE PATIENT PRESENTED TO THE ER WITH BLADDER IRRITATION ALLEGEDLY RELATED TO MESH PLACEMENT. THE PATIENT WAS TREATED WITH PAIN MEDICATION AND A PRESCRIPTION FOR BLADDER ANTI-SPASMODIC MEDICATION. THERE HAS BEEN NO ADDITIONAL TREATMENTS REPORTED. THE IMPLANTING SURGEON WAS NOTIFIED OF THE PATIENT'S POSTOPERATIVE BLADDER IRRITATION BY THE PATIENT DURING A POST SURGICAL FOLLOW UP VISIT. THE IMPLANTING SURGEON HAS EXPRESSED A DESIRE TO HAVE THE OPTION TO UTILIZE A SMALLER SIZE ONFLEX MESH PRODUCT AND STATES THE PATIENT'S POSTOPERATIVE CONDITION WAS "A DIRECT CAUSE AND EFFECT ISSUE" RELATED TO THE SIZE OF THE MESH IMPLANT.

  Patient problems: Irritation

  MAUDE report 9738963 ↗
• InjuryApr 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DAVOL: (B)(6) 2018 - THE PATIENT WAS IMPLANTED WITH A DAVOL ONFLEX MESH. AS REPORTED SINCE IMPLANT THE PATIENT HAD COMPLAINED OF SEVERE PAIN. (B)(6) 2018 - DUE TO PAIN THE PATIENT UNDERWENT AN ADDITIONAL SURGERY. AS REPORTED NO ABNORMALITIES WERE FOUND. FOLLOWING THE ADDITIONAL SURGERY IT IS REPORTED THAT THE PATIENT WAS FREE OF SYMPTOMS FOR APPROXIMATELY SIX WEEKS, BUT HAS STARTED TO EXPERIENCE INCREASING PAIN AND HAS BEEN UNABLE TO WORK. THE PATIENT'S DOCTOR REPORTS THAT THE PATIENT EXPERIENCED A "REJECTION REACTION" WHICH MANIFESTS ITSELF BY THE FOLLOWING SYMPTOMS: SEVERE PELVIC PAIN, INCREASED CRP (C-REACTIVE PROTEIN), LEUKOCYTOSIS, NO ABSCESS, NO SEROMA. THE PATIENT CONTINUES TO HAVE COMPLAINTS OF MALAISE AND LOCAL PAIN WITHOUT SIGNS OF BACTERIAL INFLAMMATION. CT SCAN PERFORMED ON (B)(6) EXCLUDES AN ABSCESS, BUT THE PERIFOCAL MUSCLES ARE SWOLLEN WITHOUT INVOLVEMENT OF INTRA-ABDOMINAL ORGANS.

  Patient problems: Foreign Body Reaction; Pain; Reaction

  MAUDE report 7420846 ↗