Bard 0112730Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741016578), received between Jun 20, 2017 and Feb 11, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Migration

  PER INFORMATION PROVIDED: (B)(6) 2009 - PATIENT WAS DIAGNOSED WITH VENTRAL AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD PRE-SHAPED MESH (DEVICE 1) AND BARD ¿ DART MESH (DEVICE 2). PER OP NOTES, ¿ADHESIONS WERE LYSED. THE HERNIA DEFECT WAS NOTED, AND THE OMENTUM WAS STUCK IN THE DEFECT WERE REDUCED. A PORTION OMENTUM WAS EXCISED. A BARD PRE-SHAPED MESH (DEVICE 1) WAS PLACED AND SUTURED TO FASCIA. THE UMBILICAL DEFECT WAS NOTED AND REDUCED. A MESH - DART (DEVICE 2) WAS PLACED AND SUTURED.¿ (B)(6) 2011 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF BARD ¿ DART (DEVICE 2) AND IMPLANT OF VENTRALEX MESH (DEVICE 3). PER OP NOTES, ¿ENTIRE SCAR TISSUES OF PREVIOUS SURGERY WERE EXCISED. THE PRIOR PLUG (DEVICE 2) HAD COME LOOSE AND EXCISED. MANY ADHESIONS OF SMALL BOWEL WERE LYSED. THE BOWEL AND OMENTUM WERE REDUCED FROM THE HERNIA SAC. A PORTION OF INCARCERATED OMENTUM STUCK IN THE SAC WAS EXCISED. A VENTRALEX MESH (DEVICE 3) WAS PLACED IN THE DEFECT AND SECURED USING SUTURES.¿ (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCARCERATED VENTRAL HERNIA AND ABDOMINAL PAIN THEREBY UNDERWENT OPEN REPAI

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

  MAUDE report 24313618 ↗
• InjuryDec 5, 2025Migration; Migration

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA AND INCARCERATED UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF MESH ¿ DARTS (DEVICE 1) AND MESH ¿ DARTS (DEVICE 2). PER OPERATIVE NOTES, ¿A TRANSVERSE ELLIPTICAL INCISION WAS MADE AROUND THE UMBILICUS. A LARGE MESH ¿ DARTS (DEVICE 1) WAS PLACED AND SUTURED. A VERTICAL INCISION WAS MADE OVER THE EPIGASTRIC HERNIA AND CARRIED DOWN TO THE DEFECT AND DISSECTED. A MESH ¿ DARTS (DEVICE 2) WAS PLACED AND SUTURED IN PLACE.¿ (B)(6) 2014 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA TO THE RIGHT OF THE PRIOR UMBILICAL HERNIA REPAIR THEREBY UNDERWENT OPEN REPAIR WITH VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE SCAR TISSUE WAS NOTED. THE DEFECT WAS REPAIRED WITH A VENTRALEX ST MESH (DEVICE 3) AND SUTURED.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AT THE UMBILICUS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH REMOVAL OF MESH ¿ DARTS (DEVICE 1) AND VENTRALEX ST MESH (DEVICE 3). PER OPERATIVE NOTES, ¿THE RECURRENT HERNIA AT THE UMBILICUS WITH THE PREVIOUS MESH, TURNS OUT THAT THE MESH DID NOT REMAIN ANCHORED ON THE RIGHT ABDOMINAL WALL, AN

  Patient problems: Hernia; Scar Tissue

  MAUDE report 23729898 ↗
• InjuryJul 5, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER PLAINTIFF PROFILE FORM (B)(4): ATTORNEY ALLEGES THAT THE PATIENT HAD PAIN AND HERNIA RECURRENCE. PER MEDICAL RECORDS: ON (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT GROIN INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG (DEVICE #1) AND DART MESH (DEVICE #2). PER OPERATIVE NOTES, ¿THE INCISIONAL HERNIA WAS IDENTIFIED AND A SMALL DART PLUG MESH (DEVICE #2) WAS PLACED IN THE INTERNAL RING SUPERIOR TO TRANSVERSALIS AND INFERIOR TO ILIOINGUINAL LIGAMENT. A SYNTHETIC MESH WAS TRIMMED AND PLACED UNDER EXTERNAL OBLIQUE FASCIA. AN OBVIOUS FASCIAL DEFECT WITH PROTRUDING PERITONEAL FAT WAS IDENTIFIED, REPAIRED USING TRIMMED PERFIX PLUG (DEVICE #1). THEN, THE SYNTHETIC MESH WAS PLACED OVER THIS AND SECURED TO THE PUBIC TUBERCLE AND ILIOINGUINAL LIGAMENT WITH SUTURES.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND RIGHT GROIN PAIN THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH THE EXPLANT OF PERFIX PLUG (DEVICE #1), DART MESH (DEVICE #2) AND IMPLANT OF BARD SOFT MESH (DEVICE #3). PER OPERATIVE NOTES, ¿ENCOUNTERED BOTH GROIN PLUGS AND A SMALL HERNIA NOTED IN THE FEMORAL SPACE. THE MEDIALLY PLACED GROIN

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 19679012 ↗
• InjurySep 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  PER MEDICAL RECORDS: ON (B)(6) 2005 PATIENT UNDERWENT REPAIR OF AN EPIGASTRIC HERNIA WITH IMPLANT OF A BARD/DAVOL DART MESH. ON (B)(6) 2006 THE PATIENT UNDERWENT REPAIR OF A RECURRENT EPIGASTRIC HERNIA WITH IMPLANT OF A NON BARD/DAVOL MANUFACTURED SEPRAMESH IP. THE OPERATIVE REPORT DOES NOT INDICATE THAT THE PREVIOUSLY IMPLANTED DART MESH WAS ENCOUNTERED DURING THIS REPAIR. ON (B)(6) 2009 THE PATIENT UNDERWENT REPAIR OF A RECURRENT INCISIONAL VENTRAL HERNIA WITH IMPLANT OF A NON-BARD/DAVOL BIOLOGIC MESH. THE OPERATIVE REPORT STATES THAT DURING THIS PROCEDURE AN "INCARCERATED TORN HERNIA MESH" WAS ENCOUNTERED WHICH WAS EXPLANTED DURING THE PROCEDURE

  Patient problems: Hernia

  MAUDE report 12490903 ↗
• InjuryJun 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE FOLLOWING WAS REPORTED VIA MAUDE EVENT REPORT (MW 5069673): " I HAD A SMALL UMBILICAL HERNIA THAT I NOTICED IN 2007. MY PRIMARY CARE SENT ME TO A SURGEON. ALTHOUGH VERY SMALL I WAS TOLD SURGERY WAS NEEDED. IT WAS SCHEDULED FOR EARLY 2008 AND PERFORMED ON (B)(6) 2008. ACCORDING TO THE SURGEON MY HERNIA WAS ACTUALLY LARGER THAN APPEARED AND STATED HE FOUND ANOTHER HERNIA WHILE REPAIRING THE SCHEDULED ONE. I DON'T RECALL ANY PAIN OR DISCOMFORT IN THE UPPER AREA WHERE THE SMALL EPIGASTRIC HERNIA WHICH CONTAINED A SMALL AMOUNT OF FAT WAS FOUND. I ONLY FIND ONE STICKER THAT SHOWS A DAVOL BARD MESH DART, SMALL MONOFILAMENT KNITTED POLYPROPYLENE, SIZE SMALL DART, REF 0112730 LOT 43AOD015, THAT WAS USED FOR THE REPAIR OR REPAIRS. I FIND NO SCARS OR REPAIR INDICATION ABOVE THE UMBILICAL REPAIR NO WHERE. NO DISCOMFORT AFTER SURGERY IN THE UPPER AREA AT ALL. EXTREME PAIN IN RECOVERY AROUND MY BELLY BUTTON AND INNER INTESTINAL AREA. I WAS LITERALLY SCREAMING IN PAIN. APPROXIMATELY 7 YEARS LATER I STARTED HAVING DISCOMFORT IN THE WHOLE INTESTINAL AREA AND MY PRIMARY CARE STARTED TESTING TO SEE WHAT COULD BE WRONG. WE DIDN'T SUSPECT ANOTHER HERNIA. MY DOCTOR THOUGHT MAYBE GALL STONES. AFTER M

  Patient problems: Bacterial Infection; Disability; Pain

  MAUDE report 6653840 ↗