BARD 0117015Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741030925), received between Feb 7, 2018 and Sep 28, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Patient-Device Incompatibility

  As per ANSM No (b)(4):As reported, on (b)(6) 2024 the patient underwent inguinal hernia repair with the implant of Bard Soft Pre-shaped Mesh.Type of surgery: Inguinal. Date of surgery: (b)(6) 2024.Regarding side effects:Postoperative pain: Yes, Pain still present: Yes; reoperated on (b)(6) 2026, Severity of pain: 8. Frequency of pain: periodic. Medications prescribed for pain: Yes .Pain management center: Yes. Patient's current condition: Emotional distress: anxiety, stress, loss of quality of life. Physical impairment: persistent pain, loss of mobility. Fatigue, sleep disturbances.Occupational impairment: even though I am retired from farming, I am unable to help my wife with her work.Measures taken at the healthcare facility for the patient's care: N/A.

  Patient problems: Ambulation or Postural Difficulties; Anxiety; Fatigue; Pain; Sleep Dysfunction

  MAUDE report 50917202 ↗
• InjuryFeb 27, 2026Material Deformation

  PER INFORMATION PROVIDED: ON (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF TWO BARD FLAT MESHES (DEVICE 1 AND 2). PER OPERATIVE NOTES, ¿THE PERITONEUM WAS MOBILIZED AND TWO INDIRECT INGUINAL HERNIA SACS ON RIGHT AND LEFT SIDES WERE IDENTIFIED AND REDUCED. TWO BARD FLAT MESHES (DEVICE 1 AND 2) WERE PLACED WITHIN PERITONEAL SPACE BILATERALLY AND FASCIA WAS CLOSED. TO THE SMALL UMBILICAL DEFECT, THE FASCIAL DEFECT WAS REDUCED AND CLOSED WITH SUTURES CIRCUMFERENTIALLY.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED RECURRENT LEFT INGUINAL HERNIA AND PAIN THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF BARD SOFT MESH PRE-SHAPED WITH KEYHOLE (DEVICE 3). PER OPERATIVE NOTES, ¿IN THE LEFT GROIN, THE HERNIAL DEFECT WAS REDUCED AND A PIECE OF BARD SOFT MESH PRE-SHAPED WITH KEYHOLE (DEVICE 3) WAS PLACED IN THE INGUINAL CANAL AND SECURED THE MESH WITH SUTURES.¿ ON (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH LEFT GROIN PAIN, THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH LEFT GROIN EXPLORATION AND REMOVAL OF MESHES (DEVICE 1 AND 3). PER OPERATIVE NOTES, ¿THE LEFT INGUINAL MESHES (DEVICE 1 AND 3) WERE SIGNIFICANTLY S

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 24468281 ↗
• MalfunctionJan 9, 2026Device Contamination with Chemical or Other Material

  AS REPORTED, DURING ROUTINE INSPECTION AFTER RECEIVING THE PRODUCTS, THE DISTRIBUTOR DISCOVERED UNKNOWN FILAMENT SUBSTANCES INSIDE THE STERILE PACKAGING OF A PRE SHAPED SOFT MESH. THE OUTER PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS PROPERLY SEALED BEFORE OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021192 ↗
• MalfunctionDec 16, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A PROCEDURE USING SOFT MESH PRE-SHAPED AFTER OPENING THE INNER PACKAGING, THE OPERATING ROOM NURSES OBSERVED TINY, UNIDENTIFIED FILAMENT-LIKE PARTICLES FELL TO THE FLOOR. DUE TO THE REFLECTIVE FLOOR SURFACE AND THE URGENT NATURE OF THE SURGERY, THE PARTICLES COULD NOT BE RETRIEVED. THE PACKAGING HAD BEEN CONFIRMED AS INTACT AND PROPERLY SEALED PRIOR TO OPENING. ANOTHER PATCH WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818040 ↗
• InjuryDec 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER ANSM REPORT (B)(4) IN SUMMARY: AS REPORTED ON (B)(6) 2022 THE PATIENT UNDERWENT A LICHTENSTEIN PROCEDURE, NAMELY A DIRECT APPROACH REPAIR OF A RIGHT INGUINAL HERNIA WITH ANTERIOR PLACEMENT OF A SOFT PRESHAPED MESH. THE HERNIA DIAGNOSIS WAS MADE ON THE BASIS OF RADIOLOGICAL FINDINGS. THE PATIENT DOES NOT DESCRIBE A CLINICALLY PALPABLE SAC. AS REPORTED FOLLOWING THIS PROCEDURE, PATIENT EXPERIENCED A SERIES OF PAINS THAT IS THE SUBJECT OF NUMEROUS CONSULTATIONS WITH SURGEONS AND OTHER PRACTITIONERS. PER CONSULTATION REPORT: PATIENT HAS RECEIVED COMPREHENSIVE TREATMENT FOR CHRONIC PAIN: MEDICATION, INFILTRATION ATTEMPTS, CONSULTATION WITH A SPECIALIST, AND NEUROSTIMULATION. THE LATTER TECHNIQUE APPEARS TO BE PARTIALLY EFFECTIVE. IN (B)(6) 2025, SHE SAW A PAIN SPECIALIST WHO RECOMMENDED REMOVAL OF THE INGUINAL PROSTHESIS. PER CONSULTATION REPORT: THIS PAIN, WHICH HAS BECOME CHRONIC, PERMANENT, NEUROPATHIC IN NATURE, WITH A FEELING OF STIFFNESS, COMBINES HYPOAESTHESIA TO TOUCH WITH HYPERAESTHESIA, ALLODYNIA AND TINEL'S SIGN IN THE AFFECTED AREA. IT COULD BE ASSUMED THAT THIS IS A CONSEQUENCE OF DAMAGE TO A BRANCH OF THE ILIOINGUINAL OR GENITOFEMORAL NERVE, OR ITS INVOLVEMENT IN THE P

  Patient problems: Ambulation or Postural Difficulties; Hypoesthesia; Nerve Damage; Neuropathy

  MAUDE report 23703692 ↗
• InjurySep 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH RIGHT INCISIONAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH IMPLANT OF PERFIX PLUG (DEVICE 1). PER OPERATIVE NOTES, ¿THE INCISIONAL HERNIA WAS IDENTIFIED AND A PERFIX PLUG (DEVICE 1) WAS PLACED INTO THE CAESAREAN HOLE AND AN ONLAY MESH WAS PLACED ON TOP AND SEWED IT TO THE CONJOINED TENDON.¿ (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC ABDOMINAL PAIN IN THE LOWER ABDOMEN THEREBY UNDERWENT LAPAROSCOPIC REPAIR. PER OPERATIVE NOTES, ¿A LARGE AMOUNT OF OMENTAL TYPE ADHESIONS IN THE LOWER ABDOMINAL AREA WERE TAKEN DOWN. A PERFIX PLUG (DEVICE 1) IN THE RIGHT LOWER QUADRANT THAT IS STICKING INTO THE ABDOMINAL AREA WHICH WAS CAUSING A CHRONIC PAIN.¿ (B)(6) 2018 ¿ PATIENT HAD LOWER ABDOMINAL PAIN AND DIAGNOSED WITH ABDOMINAL WALL SEROMA THEREBY UNDERWENT INCISION AND DRAINAGE OF SEROMA. (B)(6) 2018 ¿ PATIENT WAS DIAGNOSED WITH CHRONIC ABDOMINAL WALL PAIN, MESHOMA AND VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE REMOVAL OF MESH (DEVICE 1) AND IMPLANT OF PRE-SHAPED SOFT MESH (DEVICE 2). PER OPERATIVE NOTES, ¿A MESHOMA WAS IDENTIFIED. THE PREVIOUS MESH (DEVICE 1) THAT HAD CURLED UP INTO A BALL WAS REMOVED. THE RESUL

  Patient problems: Adhesion(s); Hernia

  MAUDE report 23002467 ↗
• InjuryAug 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED BY ANSM IN SUMMARY: THE PATIENT UNDERWENT A COMPLICATED HYSTERECTOMY, WITH SUBSEQUENT APPEARANCE OF BILATERAL INGUINAL HERNIA. ON (B)(6) 2024 THE PATIENT UNDERWENT REPAIR OF THE HERNIA USING THE LICHTENSTEIN TECHNIQUE AND PLACEMENT OF A SOFT MESH PRE-SHAPED W/ KEYHOLE. AS REPORTED THE PATIENT HAS BEEN EXPERIENCING INTENSE PAIN AT THE RIGHT SCAR SITE FOLLOWING SURGERY AND PRESENTED TO HER DOCTOR ON (B)(6) 2024. PER DOCTORS NOTE , "SHE IS STILL VERY PAINFUL, WITH PAIN LINKED TO SUPRAPUBIC EDEMA AND PAIN AT THE LEVEL OF THE RIGHT INGUINAL SCAR, WITH SUSPECTED GRANULOMA OR NEUROMA. SHE WILL HAVE HER COMPLEMENTARY MRI IN EARLY (B)(6). ON EXAMINATION TODAY, IT WAS DIFFICULT TO LOCALIZE THE NEUROMA, AS THERE WAS NO SPECIFIC AREA OF PAIN. INGUINAL REGION IS VERY SENSITIVE. WHILE WAITING FOR THE MRI, I SUGGEST AN ILEOFASCIAL BLOCK FOR PAIN RELIEF TODAY. I HOPE THIS WILL RELIEVE HER FOR A FEW DAYS. I'LL SEE HER AGAIN AS SOON AS SHE'S HAD HER MRI, AND I'LL BE SURE TO KEEP YOU INFORMED OF WHAT TO DO NEXT." PATIENT'S CURRENT CONDITION: "INTENSE PAIN IN THE RIGHT SCAR DIFFUSE NEUROPATHIC PAIN. PAIN ON THE TOP OF THE LEGS AND TOP OF THE FEET FLOATING SENSATION IN THE RIGHT GROIN ELECT

  Patient problems: Neuropathy; Pain; Swelling/ Edema

  MAUDE report 22853246 ↗
• InjuryAug 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH INDIRECT BILATERAL INGUINAL HERNIA, FEMORAL HERNIA AND UMBILICAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD PRE-SHAPED WITH KEYHOLE MESH (RIGHT - DEVICE #1) & BARD SOFT MESH PRE-SHAPED W/ KEYHOLE (LEFT - DEVICE #2). PER OPERATIVE NOTES, ¿ON RIGHT, A LARGE INDIRECT HERNIA DEFECT WAS IDENTIFIED. FLOOR WAS REINFORCED USING BARD PRE-SHAPED WITH KEYHOLE MESH (DEVICE #1), WHICH SECURED TO SYMPHYSIS PUBIS USING SUTURE. ON LEFT, A SMALL INDIRECT HERNIA AND FEMORAL HERNIA WAS NOTED. A BARD SOFT MESH PRE-SHAPED W/ KEYHOLE (DEVICE #2) WAS SECURED TO PUBIC TUBERCLE USING SUTURES. AN UMBILICAL HERNIA WAS REPAIRED USING SUTURES.¿ (B)(6) 2020 ¿ PATIENT WAS DIAGNOSED WITH BILATERAL INGUINAL PAIN, RECURRENT DIRECT RIGHT INGUINAL HERNIA, RECURRENT VENTRAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF BARD PRE-SHAPED WITH KEYHOLE MESH (RIGHT - DEVICE #3) FOR RIGHT INGUINAL HERNIA AND BARD FLAT MESH (DEVICE #4) FOR VENTRAL HERNIA. PER OPERATIVE NOTES, ¿ON RIGHT, A RECURRENT HERNIA WAS NOTED. THE ILIOINGUINAL NERVE AND GENITOFEMORAL NERVE ENCASED IN SCAR WAS AMPUTATED. THE ILIOHYPOGASTRIC NERVE WAS FOUND PR

  Patient problems: Nerve Damage; Pain

  MAUDE report 22749041 ↗
• InjuryDec 12, 2024Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL PERFIX PLUG ON (B)(6) 2010 AND BARD SOFT MESH PRE-SHAPED ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. ATTORNEY ALLEGES THE MESH PRODUCTS "WERE DETERMINED TO HAVE FAILED, CAUSING CHRONIC INFLAMMATION, ADHERENCE, EROSION AND RECURRENT HERNIAS, AND REMOVED" ON (B)(6) 2022. ATTORNEY ALLEGES GENERAL ALLEGATIONS FOR "PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED BY THE PATIENT." IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Erosion; Hernia; Inflammation; Insufficient Information; Pain

  MAUDE report 20912512 ↗
• InjurySep 11, 2018No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  AS REPORTED ON (B)(6) 2018, THE PATIENT UNDERWENT THE REPAIR OF BILATERAL INGUINAL HERNIAS. THE HERNIAS WERE REPAIRED WITH BARD/DAVOL SOFT MESH (LOT # HUBX1610). IT IS REPORTED THAT SHORTLY AFTERWARDS, THE PATIENT DEVELOPED IRRITATION AND LOCAL PAIN WITH INTERMITTENT SWELLING AT THE SURGICAL SITES. HE ALSO HAS DEVELOPED OVER RECENT MONTHS MULTIPLE SYMPTOMS INCLUDING INCREASED FATIGUE, WEIGHT LOSS, AND ¿ALLERGIES¿ TO SOME FOODS INCLUDING RAW APPLES AND POTATOES AND TO MULTIPLE MEDICATIONS. AT THIS TIME THE ALLERGIST IS NOT CERTAIN WHAT IS CAUSING THESE SYMPTOMS AND WOULD LIKE TO OBTAIN A SAMPLE OF THE MESH TO RULE THIS OUT.

  Patient problems: Pain; Reaction; Swelling

  MAUDE report 7863998 ↗
• InjurySep 7, 2018No Apparent Adverse Event; Patient Device Interaction Problem; No Apparent Adverse Event; Patient Device Interaction Problem

  AS REPORTED ON (B)(6) 2018 THE PATIENT UNDERWENT THE REPAIR OF BILATERAL INGUINAL HERNIAS. THE HERNIAS WERE REPAIRED WITH BARD/DAVOL SOFT MESH (LOT # HUBX1610). IT IS REPORTED THAT SHORTLY AFTERWARDS, THE PATIENT DEVELOPED IRRITATION AND LOCAL PAIN WITH INTERMITTENT SWELLING AT THE SURGICAL SITES. HE ALSO HAS DEVELOPED OVER RECENT MONTHS MULTIPLE SYMPTOMS INCLUDING INCREASED FATIGUE, WEIGHT LOSS, AND ¿ALLERGIES¿ TO SOME FOODS INCLUDING RAW APPLES AND POTATOES AND TO MULTIPLE MEDICATIONS. AT THIS TIME THE ALLERGIST IS NOT CERTAIN WHAT IS CAUSING THESE SYMPTOMS AND WOULD LIKE TO OBTAIN A SAMPLE OF THE MESH TO RULE THIS OUT.

  Patient problems: Pain; Reaction; Swelling

  MAUDE report 7854933 ↗
• InjuryFeb 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO (B)(6) AND FORWARDED TO DAVOL: ON (B)(6) 2007 - THE PATIENT WAS IMPLANTED WITH A BARD PRE-SHAPED SOFT MESH DURING A PROCEDURE TO REPAIR BILATERAL INGUINAL HERNIAS IT IS ALLEGED THAT, "THE MESH HAS CAUSED CHRONIC PAIN, BOWEL AND BLADDER PROBLEMS AND MANY OTHER HEALTH ISSUES FOR THE PAST TEN YEARS. SURGEONS SAY IT IS IMPOSSIBLE TO REMOVE IT, CERTAINLY NOT WITHOUT A HIGH RISK OF CONSIDERABLE DAMAGE TO TISSUE AND ORGANS. REGARDING THE MESH, NO ACTION HAS BEEN TAKEN."

  Patient problems: Pain

  MAUDE report 7246968 ↗