RECONIX 0114510Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741011832), received between Dec 28, 2017 and Nov 14, 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. How this data works · Data updated Oct 13, 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.

• InjuryNov 14, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT FLANK VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF RECONIX MESH (DEVICE 1). PER OPERATIVE NOTES, ¿MULTIPLE ADHESIONS WERE TAKEN DOWN. A RECONIX MESH (DEVICE 1) WAS PLACED AND SUTURED INTO THE DEFECT.¿ (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH RIGHT FLANK RECURRENT HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF RECONIX MESH (DEVICE 2) AND BARD FLAT MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE SCAR TISSUE WAS EXCISED. THE OLD RECONIX MESH (DEVICE 1) WAS IDENTIFIED, AND DISSECTION REVEALED A HERNIA. THE HERNIA SAC WAS DISSECTED. IN THE PERITONEAL SIDE OF THE HERNIA, A RECONIX MESH (DEVICE 2) WAS PLACED AND SUTURED. A BARD FLAT MESH (DEVICE 3) WAS PLACED AND TACKED.¿ (B)(6) 2006 ¿ PATIENT WAS DIAGNOSED WITH RIGHT FLANK RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MESHES (DEVICE 1, 2, 3) AND AN IMPLANT OF DULEX MESH (DEVICE 4). PER OPERATIVE NOTES, ¿A SIGNIFICANT ADHESIOLYSIS OF THE RIGHT COLON THAT WAS ADHERED TO THE HERNIA SAC ITSELF. THERE WAS ANOTHER PRIOR MESH WAS SEEN THAT SEEMED TO HAVE HAD FALLEN AWAY FROM PART OF THE WALL. THE MULTIPLE GORE-

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23553262 ↗
• InjuryOct 10, 2019Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  PER INFORMATION PROVIDED BY THE PATIENT'S ATTORNEY, MEDICAL RECORDS & PRODUCT ID PAGE: ON (B)(6) 2008 THE PATIENT WAS DIAGNOSED WITH VAGINAL VAULT PROLAPSE, STRESS URINARY INCONTINENCE AND UNDERWENT A LAPAROSCOPIC ABD SACROCOLPOPEXY WITH IMPLANT OF A BARD/DAVOL FLAT MESH, LAPAROSCOPIC BURCH PROCEDURE AND CYSTOURETHROSCOPY. PER THE OPERATIVE REPORT DETAILS, "A PIECE OF GORE-TEX (DAVOL RECONIX) GRAFT MATERIAL, 1 MM THICK, 4 CM WIDE AND 10 CM LONG WAS INSERTED INTO THE PERITONEAL CAVITY AND THE DISTAL END OF THE GRAFT WAS SUTURED TO THE POSTERIOR APEX OF THE VAGINA WITH 8 SUTURES. THE PROXIMAL PORTION OF THE GRAFT WAS TACKED TO THE SACRAL PROMONTORY WITH PRO TACKER." ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 9176789 ↗
• InjuryDec 28, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON A REVIEW OF LIMITED MEDICAL RECORDS AND THE ATTORNEY'S LEGAL CLAIM PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: ON (B)(6) 2004 - THE PATIENT WAS DIAGNOSED WITH VAGINAL WALL PROLAPSE WITH RECTOCELE AND ENTEROCELE. THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH IMPLANT OF A BARD DAVOL RECONIX MESH, VAGINAL POSTERIOR REPAIR AND ENTEROCELE REPAIR. THE ATTORNEY ALLEGES THE PATIENT EXPERIENCED "RECURRENCE OF ORIGINAL PROBLEM, SEVERE LOWER ABDOMINAL PAIN AND BOWEL PROBLEMS." IT IS ALLEGED THE DOCTOR TREATED THE PATIENT FOR PAIN AND REFERRED HER TO A PAIN SPECIALIST.

  Patient problems: Pain; Prolapse

  MAUDE report 7153035 ↗