BARD 0117008Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741030857), received between Dec 28, 2017 and Feb 26, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF 3DMAX MESHES (RIGHT - DEVICE 1, LEFT- DEVICE 2). PER OP NOTES, ¿INGUINAL HERNIAS WERE NOTED. A MEDIUM 3DMAX MESH (DEVICE 1) WAS PLACED ACCORDINGLY ON THE RIGHT- SIDE AND TACKED TO THE PUBIC TUBERCLE MEDIALLY ALONG COOPERS LIGAMENT AND THEN UP ON THE RECTUS FASCIA ANTERIORLY. IN LIKEWISE FASHION, THE LEFT INGUINAL HERNIA WAS REPAIRED WITH LEFT SIDED 3DMAX MESH (DEVICE 2).¿ ON (B)(6) 2008 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE 3). PER OP NOTES, ¿DIRECT HERNIA DEFECT WAS PALPABLE INFERIOR TO THE INGUINAL FLOOR JUST SUPERIOR TO THE INGUINAL LIGAMENT. A SMALL PERFIX PLUG (DEVICE 3) WAS PLACED, AND PATCH WAS PLACED TO REINFORCE THE FLOOR USING SUTURES.¿ ON (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH SEVERE LEFT GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESHES (DEVICE 2, 3) AND IMPLANT OF BARD SOFT MESH (DEVICE 4). PER OP NOTES, ¿THE UNDERLYING PREVIOUSLY EXISTING MESH (DEVICE 2, 3) HAD TORN COMPLETELY AWAY FROM DEEP SPACE AND COMPL

  Patient problems: Hernia

  MAUDE report 24455559 ↗
• MalfunctionAug 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, THE PATIENT WAS IMPLANTED WITH SOFT MESH "TWO WEEKS AGO" (CONTACT COULD NOT REMEMBER THE EXACT DATE). CONTACT REPORTS THE PATIENT "IS HAVING COMPLICATIONS FROM THE MESH - NOT ABLE TO BREATH ON HER OWN AFTER SURGERY, IN A LOT OF PAIN, ON DIFFERENT KINDS OF MEDICATION."

  Patient problems: Dyspnea; Pain

  MAUDE report 22850596 ↗
• InjuryApr 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A SOFT MESH. CASE-SPECIFIC DETAILS NOT PROVIDED. ADDENDUM PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2018 - PATIENT WAS DIAGNOSED WITH DIRECT RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD SOFT MESH. PER OPERATIVE NOTES, "THE DIRECT INGUINAL SAC WAS IDENTIFIED AND SEPARATED FROM THE CORD. THIS WAS REDUCED AND A BARD SOFT MESH WAS SHAPED INTO SIZE AND SECURED AT THE PUBIC TUBERCLE WITH SUTURES. THE MESH WAS THEN OVERLAPPED TO RECREATE THE DEEP RING AND AGAIN SECURED WITH SUTURES." (B)(6) 2019 TO (B)(6) 2021 - PATIENT HAD HERNIA, GROIN PAIN AND PROVIDED WITH ANTI-INFLAMMATORY MEDICATIONS.

  Patient problems: Hernia; Insufficient Information

  MAUDE report 19211830 ↗
• InjuryApr 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES MULTIPLE PATIENTS HE REPRESENTS HAVE EXPERIENCE UNSPECIFIED INJURY AND ALLEGE THEY MAY HAVE REQUIRED ADDITIONAL MEDICAL/SURGICAL TREATMENT. ATTORNEY ALLEGES THIS PATIENT WAS TREATED WITH A SOFT MESH. CASE-SPECIFIC DETAILS NOT PROVIDED.

  Patient problems: Hernia; Insufficient Information; Seroma

  MAUDE report 19211760 ↗
• InjuryJun 20, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY, IMPLANT OPERATIVE REPORT AND IMPLANT TRACKING LOG ALLEGE THE FOLLOWING: ON (B)(6) 2009 - THE PATIENT WAS DIAGNOSED WITH CYSTOCELE, STRESS URINARY INCONTINENCE AND UNDERWENT A CYSTOCELE REPAIR AND A MID-URETHRAL SLING CYSTOSCOPY WITH IMPLANT OF A BARD/DAVOL SOFT MESH. ATTORNEY ALLEGES UNSPECIFIED ADVERSE PATIENT OUTCOMES ASSOCIATED WITH USE OF DEVICE.

  Patient problems: No Information

  MAUDE report 7622660 ↗
• InjuryJan 9, 2018Defective Device; Defective Device

  THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2007 - THE PATIENT WAS DIAGNOSED WITH STRESS INCONTINENCE AND UNDERWENT A CYSTOSCOPY PROCEDURE AND MID-URETHRAL SLING IMPLANT USING A BARD SOFT MESH. (B)(6) 2014 - THE PATIENT PRESENTED WITH RECURRENT URINARY TRACT INFECTIONS AND URINARY INCONTINENCE. AN IN OFFICE CYSTOSCOPY NOTED THE PATIENT HAD ANTERIOR EROSION OF MESH (DAVOL SOFT). THE PATIENT WAS DIAGNOSED WITH INTRAURETHRAL MESH EROSION AND UNDERWENT PARTIAL EXCISION OF THE BARD SOFT MESH FOLLOWED BY CYSTOSCOPY. PER OPERATIVE REPORT DETAILS "THE MESH (DAVOL SOFT) EROSION WAS NOTED ANTERIORLY VERY DISTAL TO THE URETHRA. THIS WAS EXCISED LATERALLY TO REMOVE THE ENTIRE PORTION OF MESH THAT WAS INTRAURETHRAL."

  Patient problems: Erosion; Incontinence; Urinary Tract Infection

  MAUDE report 7175921 ↗
• InjuryDec 28, 2017Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING IS BASED ON A REVIEW OF MEDICAL RECORDS PROVIDED TO DAVOL BY THE PATIENT'S ATTORNEY: (B)(6) 2012 - THE PATIENT WAS DIAGNOSED WITH A TOTAL VAULT PROLAPSE WITH A LARGE CYSTOCELE. THE PATIENT UNDERWENT A LAPAROTOMY, OPEN SACROCOLPOPEXY WITH IMPLANT OF A BARD SOFT MESH, REPAIR OF VAGINAL VAULT OPENING AND BURCH BLADDER SUSPENSION FOLLOWED BY CYSTOSCOPY. (B)(6) 2013 - THE PATIENT HAD AN MD OFFICE VISIT WHERE THE PATIENT COMPLAINED OF A VAGINAL BULGE OR PRESSURE AND UNDERWENT OFFICE CYSTOSCOPY. THE PATIENT WAS DIAGNOSED WITH PELVIC PROLAPSE. (B)(6) 2013 - THE PATIENT WAS DIAGNOSED WITH SYMPTOMATIC PELVIC PROLAPSE AND UNDERWENT A CYSTOCELE REPAIR WITH IMPLANT OF TWO NON-BARD DAVOL GRAFTS AND A NON BARD DAVOL MESH, SACROSPINOUS LIGAMENT VAGINAL VAULT SUSPENSION AND CYSTOSCOPY. THERE WAS NO MENTION OF ANY VISUALIZATION OR INVOLVEMENT OF THE PREVIOUSLY IMPLANTED BARD SOFT MESH.

  Patient problems: Prolapse

  MAUDE report 7150794 ↗