Bard 0112740Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741016585), received between Jul 12, 2019 and Dec 12, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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.

• InjuryDec 12, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2011- PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 1). PER OP NOTES, ¿A LARGE DIRECT HERNIA WAS IDENTIFIED IN THE RIGHT INGUINAL REGION. A BARD FLAT MESH (DEVICE 1) WAS PLACED ON THE POSTERIOR WALL OF INGUINAL CANAL AND SUTURED¿. (B)(6) 2012- PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD FLAT MESH (DEVICE 2). PER OP NOTES, ¿THE OLD SCAR WAS DISSECTED. BARD FLAT MESH (DEVICE 1) WAS FOUND RETRACTED TOWARDS THE INGUINAL LIGAMENT WHICH WAS THEN TACKED AND SUTURED. AN INDIRECT HERNIA WAS IDENTIFIED; A BARD FLAT MESH (DEVICE 2) WAS PLACED AND SUTURED¿. (B)(6)2013- PATIENT WAS DIAGNOSED WITH RECURRENT DIRECT RIGHT INGUINAL HERNIA, THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF DART MESH (DEVICE 3). PER OP NOTES, ¿A LARGE, SCARRED HERNIA SAC WAS IDENTIFIED INFERIOR TO THE CORD AND WAS DISSECTED. A DART MESH (DEVICE 3) WAS PLACED ON THE FLOOR OF THE INGUINAL CANAL AND SUTURED¿. (B)(6) 2014- PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIAS, RIGHT RECURRENT, LEFT DIRECT, THEREBY UNDERWENT LAPROSCOPIC REPAIR WITH IMPLANT

  Patient problems: Hernia

  MAUDE report 23788185 ↗
• InjuryJul 2, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2010 - PATIENT WAS DIAGNOSED WITH INCARCERATED VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF DART MESH (DEVICE #1). PER OPERATIVE NOTES, ¿INCARCERATED EPIGASTRIC HERNIA WAS IDENTIFIED, AND THE OMENTUM WAS REDUCED IN THE PERITONEAL CAVITY. A LARGE DART MESH (DEVICE #1) WAS PLACED AND SECURED OVER THE BOWEL AND OMENTUM USING SUTURES.¿ ON (B)(6) 2012 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #2) AND REMOVAL OF DART MESH (DEVICE #1). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED DART MESH (DEVICE #1) WAS REMOVED. THEN A LARGE HERNIA DEFECT WAS IDENTIFIED. A VENTRALIGHT ST (DEVICE #2) WAS USED FOR REPAIR AND SECURED BY SUTURES.¿ ON (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF VENTRALIGHT ST (DEVICE #3) AND EXPLANT OF VENTRALIGHT ST (DEVICE #2). PER OPERATIVE NOTES, ¿PREVIOUSLY PLACED VENTRALIGHT ST MESH (DEVICE #2) WAS REMOVED. THEN A VENTRALIGHT ST (DEVICE #3) WAS USED FOR REPAIR AND SECURED IN A SUBFASCIAL PLANE USING SUTURES.¿ ON (B)(6) 2017 - PATIENT WAS DIAGNOSED WIT

  Patient problems: Hernia

  MAUDE report 22380499 ↗
• InjuryJul 12, 2019Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL BARD (MARLEX) MESH DART ON (B)(6) 2002. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL BARD (MARLEX) MESH DART. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8786188 ↗