DULEX 0118241Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741011870), received between Jun 12, 2018 and Apr 28, 2025 — classified as 3 injuries.

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

• InjuryApr 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH DULEX MESH FOR A HERNINA REPAIR. THE PATIENT PRESENTED WITH A BULGE FROM HERNIA AND PAIN. AS REPORTED, "HE NEVER HEALED FROM THE HERNIA PROCEDURE AND WAS SUPPOSED TO HAVE ANOTHER ONE TO REMOVE THE MESH, BUT PROVIDER LEFT IN AND SNIPPED THE CORNERS AND HAD TO HAVE A DRAIN TUBE AS WELL AND BECAME SEPTIC. WE WAITED ANOTHER 6-8 WEEKS AND HAD TO HAVE ANOTHER PROVIDER REMOVE THE MESH BY ANOTHER PROCEDURE ON (B)(6) 2016.

  Patient problems: Pain; Sepsis

  MAUDE report 21918544 ↗
• InjuryFeb 21, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED: (B)(6)2010 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF DULEX MESH (DEVICE #1). PER OPERATIVE NOTES, ¿IN THE LEFT LOWER QUADRANT, SOME DENSE ADHESIONS TO THE SAC WERE DIVIDED. THERE WAS AN ADDITIONAL SUPERIOR ASPECT HERNIA JUST TO THE RIGHT OF MIDLINE WAS IDENTIFIED, ADHESIONS WERE DIVIDED. A CUTANEOUS BRIDGE WHICH HAD AN OLD PIECE OF MESH WAS DIVIDED, AND A DULEX MESH (DEVICE #1) WAS PLACED AND SUTURED.¿ (B)(6)2012 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT FLANK HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE PARTIAL REMOVAL OF DULEX MESH (DEVICE #1) AND IMPLANT OF VENTRALIGHT ST MESH (DEVICE #2). PER OPERATIVE NOTES, ¿AFTER EXTENSIVE LYSIS OF ADHESIONS, THE HERNIA SAC WAS DISSECTED. THE PREVIOUS MESH (DEVICE #1) WAS RESECTED AND REMOVED. A VENTRALIGHT ST MESH (DEVICE #2) WAS PLACED AND SUTURED.¿ (B)(6)2015 - PATIENT WAS DIAGNOSED WITH MULTI-RECURRENT VENTRAL INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF DULEX MESH (DEVICE #1) AND IMPLANT OF SYNTHETIC MESH. PER OPERATIVE NOTES, ¿THE HERNIA SAC WAS FOUND HERNIATED INTO THE SIGMOID COLON. THE ADHESIONS WERE LYSED, AND HERNIA

  Patient problems: Adhesion(s); Hernia; Scar Tissue

  MAUDE report 21431423 ↗
• InjuryJun 12, 2018Defective Device; Defective Device

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY AND MEDICAL RECORDS: ON (B)(6) 2007: THE PATIENT WAS DIAGNOSED WITH STRESS URINARY INCONTINENCE, VAGINAL RELAXATION, ABNORMAL BLEEDING, RIGHT ADNEXAL MASS AND UNDERWENT A TWO PART PROCEDURE WHICH INCLUDED TOTAL ABD HYSTERECTOMY, BILAT SALPINGO-OOPHORECTOMY, AN ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL DULEX MESH TO REDUCE ENTEROCELE AND IMPLANT OF A TENSION-FREE VAGINAL TAPE USING A NON BARD/DAVOL "GYNECARE TVT" MESH SLING. ON (B)(6) 2009: THE PATIENT WAS DIAGNOSED WITH EROSION OF VAGINAL MESH AND UNDERWENT A PARTIAL EXCISION OF THE VAGINAL MESH AND CLOSURE OF THE VAGINA. PER OPERATIVE DICTATION "2CM AREA A GRANULATION TISSUE WAS NOTED AT THE APEX OF THE VAGINA AND WAS TRIMMED AWAY. IT WAS NOTED AT THAT TIME, THERE WAS A 1CM AREA OF "SUSPENSION MESH" THAT WAS PRESENT IN THE CENTER OF THIS AREA THAT HAD TO GRANULATION TISSUE IN IT. THE MESH (DULEX) WAS GRASPED, ALL OF WHICH APPEARED TO BE RETROPERITONEAL AND EXCISED IN SEVERAL SMALL PIECES. ALL VISIBLE MESH WAS REMOVED". THE PATIENT IS REPORTED TO HAVE HAD PERSISTENT VAGINAL PAIN AND DRAINAGE. ON (B)(6) 2015: THE PATIENT WAS DIAGNOSED WITH ERODED MESH INTO VAGINA AND UNDERWEN

  Patient problems: Abnormal Vaginal Discharge; Erosion; Pain

  MAUDE report 7591172 ↗