BARD 0117013Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741030901), received between Jan 9, 2019 and Apr 14, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Patient-Device Incompatibility

  AS PER ANSM N° R2609569: AS REPORTED, THE PATIENT WAS IMPLANTED WITH BARD SOFT PRE-SHAPED MESH ON (B)(6) 2020. THE PATIENT UNDERWENT REMOVAL OF THE MESH ON (B)(6) 2021. DATE OF OCCURRENCE: ON (B)(6) 2020. DESCRIPTION OF THE INCIDENT: "UNBEARABLE PARIETAL PAIN. CHRONIC FATIGUE. MEMORY LOSS. PAIN IN BOTH LEGS. PAINKILLERS INEFFECTIVE." PATIENT¿S CURRENT CONDITION: LOSS OF INDEPENDENCE. INTRACTABLE PAIN MAKING ANY SOCIAL LIFE IMPOSSIBLE. ACTIONS TAKEN AT THE HEALTHCARE FACILITY TO MANAGE THE PATIENT: N/A.

  Patient problems: Fatigue; Memory Loss/Impairment; Pain

  MAUDE report 24876198 ↗
• InjuryFeb 11, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH LEFT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF VENTRIO ST MESH (DEVICE 1). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE SUPERIOR TO THE INGUINAL LIGAMENT OVER THE EXTERNAL RING AND CARRIED DOWN TO THE FASCIA OF THE EXTERNAL OBLIQUE. THE LEFT INGUINAL HERNIA SAC WAS DISSECTED OUT. A VENTRIO ST MESH (DEVICE 1) WAS PLACED INTO THE LEFT INGUINAL REGION AND SECURE IT WITH SUTURES.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, ADHESION THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT PRE-SHAPED MESH (DEVICE 2). PER OPERATIVE NOTES, ¿AN INCISION WAS MADE AND CARRIED DOWN TO THE EXTERNAL OBLIQUE. THE HERNIA SAC WAS DISSECTED OUT. ALL ADHESIONS WERE TAKEN DOWN. LYSIS OF ADHESIONS WERE PERFORMED. A BARD SOFT PRE-SHAPED MESH (DEVICE 2) WAS PLACED AND ANCHORED AT THE PUBIC TUBERCLE WITH SUTURED.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA, ADHESION, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 3) AND LYSIS OF ADHESION. PER OPERATIVE NOTES, ¿AN INCISION WAS MADE INFRAUMBILICAL AND CARRIED DOWN TO THE LEVEL OF THE FASCIA.

  Patient problems: Adhesion(s); Hernia

  MAUDE report 24311493 ↗
• MalfunctionJan 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BARD SOFT MESH TORE WHILE THE SURGEON WAS ATTEMPTING TO FIXATE USING SUTURES. AS REPORTED THAT ADDITIONAL SUTURES WERE USED TO COMPLETE THE REPAIR. THERE WAS NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8230779 ↗
• MalfunctionJan 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BARD SOFT MESH TORE WHILE THE SURGEON WAS ATTEMPTING TO FIXATE USING SUTURES. AS REPORTED THAT ADDITIONAL SUTURES WERE USED TO COMPLETE THE REPAIR. THERE WAS NO INJURY TO THE PATIENT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8230776 ↗