BARD 0117014Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741030918), received between Apr 5, 2022 and Nov 21, 2025 — classified as 3 injuries, 2 malfunctions.

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

• InjuryNov 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX MESH (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿TO THE RIGHT OF MIDLINE, A DIRECT HERNIA AND INDIRECT HERNIA IN THE LEFT SIDE WAS NOTED. BOTH HERNIAS WERE REDUCED AND TWO LARGE 3DMAX MESHES (DEVICE 1 AND 2) WERE PLACED OVER THE DEFECT IN THE RIGHT AND LEFT SIDE AND FASCIA WAS CLOSED SUTURES.¿ (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH PRE-SHAPED (DEVICE 3). PER OPERATIVE NOTES, ¿A HERNIA DEFECT IN THE RIGHT UPPER ABDOMINAL WALL WAS NOTED AND REDUCED. THE DENSE SCAR TISSUE WAS REDUCED AND TO THE VENTRAL DEFECT, A PIECE OF BARD SOFT MESH PRE-SHAPED (DEVICE 3) WAS PLACED OVER THE FASCIA AND SUTURED IN PLACE.¿ (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH REMOVAL OF MIDLINE MESHES (DEVICE 1 AND 3) AND IMPLANT OF BARD SOFT MESH (DEVICE 4). PER OPERATIVE NOTES, ¿MULTIPLE HERNIA DEFECTS IN AND AROUND THE MIDLINE AND DENSE ADHESIONS TO ABDOMINAL WALL WAS REDUCED. THE MESH IN THE RIGHT OF MIDLINE (DEVICE 1) AND MESH

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

  MAUDE report 23616753 ↗
• InjurySep 12, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  AS REPORTED ON (B)(6) 2023 THE PATIENT WAS IMPLANTED WITH A BARD/BD SOFT MESH. REPORTEDLY, ¿THE PATIENT HAD POSTOPERATIVE PAIN AND POOR MOBILITY, MAINLY IN THE LOWER ABDOMEN, WHICH WAS CONSIDERED TO BE CAUSED BY THE STIMULATION OF THE PATCH (SOFT MESH). IT WAS SUSPECTED THAT THE PATCH MATERIAL WAS SLIGHTLY HARD AND IRRITATING HUMAN TISSUES.¿ IT WAS REPORTED THAT THE PATIENT WAS TREATED WITH "SYMPTOMATIC TREATMENT¿ AND THE PATIENT¿S STATUS IS NOW GOOD.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 17730442 ↗
• MalfunctionApr 18, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING LAPAROSCOPIC SURGERY, WHEN THE SURGEON OPENED THE SOFT MESH PACKAGE, A BLACK FOREIGN MATERIAL WAS NOTED ON THE PRODUCT. IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTED ON THE OUTER AND INNER PACKAGE WHEN RECEIVED AND THE PRODUCT BOX WAS COMPLETELY SEALED PRIOR TO OPENING. THE SURGEON DID NOT USE THE MESH AND THE PROCEDURE WAS COMPLETED USING ANOTHER SOFT MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16763679 ↗
• InjuryDec 14, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS PER NMPA (CHINA FDA): AS REPORTED, THE PATIENT UNDERWENT AN INDIRECT HERNIA REPAIR PROCEDURE ON (B)(6) 2022 USING PRE-CUT BARD SOFT MESH. AS REPORTED FOLLOWING IMPLANT THE PATIENT HAD POST OPERATIVE WOUND REDNESS, ITCHING & SWELLING. AS REPORTED THE PATIENT WAS SUCCESSFULLY TREATED WITH ANTI-ALLERGY DEXAMETHASONE INJECTION.

  Patient problems: Erythema; Itching Sensation; Swelling/ Edema

  MAUDE report 15977584 ↗
• MalfunctionApr 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING LICHTENSTEIN HERNIORRHAPHY ON (B)(6) 2022, THE BARD SOFT MESH WAS ATTEMPTED TO IMPLANT INTO THE PATIENT. AS REPORTED, THE SURGEON TRIED TO PICK THE MESH UP AND THE MESH BROKE WITH A HOLE JUST WITH A FINGER UNDER IT. IT WAS ALSO REPORTED THAT THERE WAS NO TEAR/HOLE ON THE MESH IDENTIFIED WHEN OPENING THE PACKAGE OR PRIOR TO INSERTION INTO THE PATIENT. AS REPORTED, THE SURGEON USED ANOTHER BARD SOFT MESH TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014452 ↗