BARDRecalls & reported problems across all models

We found 25 models of BARD by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 1,538 adverse event reports in the FDA's MAUDE database, received between Nov 14, 2013 and Sep 30, 2026 — classified as 7 deaths, 1,479 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1,232 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported BARD problems

BARD models

25 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BARD 0112680

  Mesh, surgical, polymeric
  1 death494 reports
• BARD 0112660

  Mesh, surgical, polymeric
  4 deaths237 reports
• BARD 0112720

  Mesh, surgical, polymeric
  191 reports
• BARD 0112650

  Mesh, surgical, polymeric
  110 reports
• BARD 0112640

  Mesh, surgical, polymeric
  105 reports
• BARD 0112710

  Mesh, surgical, polymeric
  63 reports
• BARD 0112670

  Mesh, surgical, polymeric
  1 death52 reports
• BARD 0117016

  Mesh, surgical, polymeric
  45 reports
• BARD 0113710

  Mesh, surgical, polymeric
  42 reports
• BARD 0117009

  Mesh, surgical, polymeric
  42 reports
• BARD 0117011

  Mesh, surgical, polymeric
  41 reports
• BARD 0117010

  Mesh, surgical, polymeric
  28 reports
• BARD 0112700

  Mesh, surgical, polymeric
  17 reports
• BARD 0113700

  Mesh, surgical, polymeric
  14 reports
• BARD 0117015

  Mesh, surgical, polymeric
  12 reports
• Bard 0117840

  Mesh, surgical, polymeric
  11 reports
• BARD 0117008

  Mesh, surgical, polymeric
  7 reports
• Bard 0112730

  Mesh, surgical, polymeric
  5 reports
• BARD 0117014

  Mesh, surgical, polymeric
  5 reports
• Bard 0118002

  Mesh, surgical, polymeric
  1 death5 reports
• BARD 0117013

  Mesh, surgical, polymeric
  4 reports
• Bard 0112740

  Mesh, surgical, polymeric
  3 reports
• Bard 0118001

  Mesh, surgical, polymeric
  2 reports
• Bard 0118004

  Mesh, surgical, polymeric
  2 reports
• Bard 0118003

  Mesh, surgical, polymeric
  1 report

Recent BARD adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2005 - Patient was diagnosed with large right inguinal hernia thereby underwent open repair with implant of Composix Kugel Mesh (Device 1), synthetic mesh and Bard Flat Mesh (Device 2). Per op notes, "A right transvers incision was made. The hernia was identified and reduced. The huge direct sac was returned to its subfascial position and the indirect sac was also dissected and freed. A large Composix Kugel Mesh (Device 1) was placed through the floor of the inguinal canal and secured to Cooper¿s ligament. A second large synthetic mesh was placed through the internal ring and secured the wound subfascial portion onto the Composix Kugel Mesh (Device 1). A large piece of Bard Flat Mesh (Device 2) was placed on the entire floor of the inguinal canal and secured to the fascia at the pubic tubercle. The fascia was then closed with suture."(b)(6)2006 - Patient was diagnosed with right scrotal hematoma thereby underwent open repair with incision and drainage of hematoma. Per op notes, "An incision was made in the upper scrotum. A large amount of serous fluid was removed and the wound was irrigated, removed some of the organized fibrous material. Drain was th

  Patient problems: Fibrosis; Hematoma; Impaired Healing; Inflammation; Unspecified Infection

  MAUDE report 50949396 ↗
• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2014 - Patient was diagnosed with incarcerated umbilical hernia and incisional hernia at port site thereby underwent laparoscopic repair with implant of Bard Flat Mesh (Device 1 and 2). Per op notes, ¿Incision was made just lateral to the port site hernia in the left mid quadrant. Some adhesions were lysed. Lap-band was excised. The port site hernia was noted and reduced. A Bard Flat Mesh (Device 1) was placed and sutured. An infraumbilical incision was made. The umbilical defect was identified in the supraumbilical area with incarcerated omental fat was reduced. Reductant omentum resected. Hernia contents were reduced. A Bard Flat Mesh (Device 2) was placed and sutured.¿ (b)(6) 2017 - Patient was diagnosed with recurrent incarcerated incisional hernia thereby underwent open repair with implant of Ventrio ST (Device 3). Per op notes, ¿A vertical laparotomy incision was made just below the level of xiphoid process to just beneath the umbilicus. Multiple hernia sacs were identified. The largest sac was mobilized down. The remaining hernia sac were opened and excised. The incarcerated omentum was reduced. Extensive lysis of adhesions was performed. M

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50945175 ↗
• InjurySep 29, 2026Patient-Device Incompatibility

  Patient problems: Hernia

  MAUDE report 50929895 ↗
• 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 ↗
• InjurySep 24, 2026Patient-Device Incompatibility

  Patient problems: Pain

  MAUDE report 50889063 ↗
• MalfunctionSep 18, 2026Unsealed Device Packaging

  As reported, during a laparoscopic inguinal hernia surgery, the surgeon opened the Bard Soft Mesh package and discovered that the inner pouch was not sealed. To ensure patient safety, a new mesh was used. The outer packaging was intact with no visible damage, the product box was completely sealed, and the package had not been opened prior to entering the operating room. There was no patient injury/harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816794 ↗
• InjurySep 17, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6)2015 - Patient was diagnosed with left inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1), Bard Flat Mesh (Device 2). Per op notes, "A direct inguinal hernia was identified and dissected. The direct component was reduced and PerFix Plug (Device 1) was secured to the area of deep inguinal ring, the patch was secured to pubic tubercle." On (b)(6)2018 - Patient was diagnosed with chronic left groin pain, thereby underwent laparoscopic repair with implant of 3DMax Mesh (Device 3). Per op notes, "A moderate hiatal hernia was identified. There was no recurrent left inguinal hernia. The previously placed plug (Device 1) was found compressing on spermatic structures. A 3DMax Mesh (Device 3) was placed in the left groin area and was sutured. The old scar in the left groin was noted. Extensive adhesions between the mesh and the external oblique, conjoined tendon, spermatic vessels, vas deferens were noted. The PerFix Plug (Device 1) and Bard Flat Mesh (Device 2) was excised."

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

  MAUDE report 50797644 ↗
• InjuryAug 27, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)2011 - Patient was diagnosed with ventral hernia and parastomal hernia thereby underwent open repair with the implant of SepraMesh IP (Device 1) and Parastomal Patch (Device 2). Per op notes, "Attention to the incisional ventral hernia, a SepraMesh IP (Device 1) was placed to the anterior abdominal wall. Then a midline incision was made, the Parastomal Patch (Device 2) was placed around the stoma to cover the hernia defect using tacks."(b)(6)2012 - Patient was diagnosed with infected mesh thereby underwent repair with removal of mesh (Device 1 and 2) and lysis of adhesions. Per op notes, "A vertical midline incision was made at the prior scar. There was an abscess cavity between the mesh and the linea alba which was drained. Explanted the prior placed SepraMesh IP (Device 1) from the right and left rectus sheath. Then attention to the second mesh that was placed around the colostomy, and were able to dissect free the mesh (Device 2) and explanted around the stoma. Lysis of adhesions was performed. Then a biologic mesh was placed."

  Patient problems: Abscess; Adhesion(s); Scar Tissue; Unspecified Infection

  MAUDE report 50476015 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2006- Patient was diagnosed with ventral incisional hernia, thereby underwent open repair with implant of Composix Kugel Mesh (Device 1). Per op notes, "Hernia sac in abdominal region was identified and was dissected. A Composix Kugel Mesh (Device 1) was then placed o er the fascial defect and sutured."(b)(6) 2006 - Patient was diagnosed with ventral incisional hernia thereby underwent open repair with explant of Composix Kugel Mesh (Device 1), implant of Composix Kugel Mesh (Device 2). Per op notes, "The previous midline scar tissue was excised. The hernia sac was identified and excised. The previously placed mesh (Device 1) in the colostomy site was noted and was found bunched up and covered with adhesions sand the mesh (Device 1) was removed. A large sized Composix Kugel Mesh (Device 2) was then placed in the abdominal region and was sutured." (b)(6) 2010 - Patient was diagnosed with incisional hernia, left sided pain, thereby underwent open repair with implant of synthetic mesh. Per op notes, "The old scar was dissected. Hernia sac in left upper quadrant was identified and was dissected. A synthetic mesh was placed and sutured. In the right upper

  Patient problems: Adhesion(s); Obstruction/Occlusion

  MAUDE report 50459844 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2009 - Patient was diagnosed with incisional hernia and ventral hernia thereby underwent open repair with implant of Bard Flat Mesh (Device 1). Per operative notes, ¿A vertical incision was made directly from the umbilicus up to the superior portion of the hernia that was marked preoperatively. Left and right of umbilicus there was exposing the multiple hernia defects. The hernia defects were dissected free from surrounding tissues and were reduced back into the peritoneal cavity. Once the anterior abdominal wall had been repaired well as the umbilicus hernia defect repaired a piece of Bard Flat Mesh (Device 1) was placed into intra-abdominal wall and secured it with sutures.¿(b)(6) 2013 - Patient was diagnosed with recurrent incisional hernia thereby underwent open repair with implant of Bard Flat Mesh (Device 2). Per operative notes, ¿An incision was made in the abdominal wall extending from the xiphoid down to the umbilicus. The hernia sac was dissected out. Previously placed Bard Flat Mesh (Device 1) was identified, which was intact. A Bard Flat Mesh (Device 2) was placed into the anterior abdominal wall with old mesh and secured it with sutures.

  Patient problems: Abscess; Post Operative Wound Infection

  MAUDE report 50458138 ↗
• InjuryAug 25, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2012 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with the implant of two Bard Flat Mesh (Device 1 - left and 2 - right). Per op notes, "An incision over the left inguinal canal, a Bard Flat Mesh (Device 1 - left) was placed using sutures. An incision over the right inguinal canal, a Bard Flat Mesh (Device 2 - right) was placed using sutures."(b)(6) 2013 - Patient was diagnosed with recurrent bilateral inguinal hernias thereby underwent laparoscopic repair with the implant of two 3DMax Mesh (Device 3 - left and 4 - right). Per op notes, "Attention to the left first, a 3DMax Mesh (Device 3 - left) was placed to the cooper's ligament using tacks. Then attention to the right side, a 3DMax Mesh (Device 4 - right) was placed to the cooper's ligament using tacks."(b)(6) 2015 - Patient was diagnosed with recurrent left inguinal hernia thereby underwent repair. Per op notes, "An incision to the left inguinal canal, the previously placed mesh (Device 1 and 3) was seen which is lateral to the pubic tubercle. An unknown was placed to the pubic tubercle using prolene sutures."

  Patient problems: Hernia

  MAUDE report 50434991 ↗
• InjuryAug 17, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2018- Patient was diagnosed with symptomatic left inguinal hernia thereby underwent laparoscopic repair with implant of Bard Soft Mesh (Device 1) and a synthetic mesh. Per op notes, "An incision was made to the subcutaneous tissue and extended until the anterior rectus sheath was encountered. A large indirect inguinal hernia was identified. On the right-side, a small to moderate sized inguinal hernia was identified and reduced. There was no direct hernia identified. A synthetic mesh was placed, aligned from the ASIS to mid of the pubis and secured with tacks to the Cooper¿s ligament. On the left side, a Bard Soft Mesh (Device 1) was placed and aligned from the ASIS to mid of the pubis and secured with tacks. Both the meshes were positioned posterior and lateral to the peritoneum and the fascia of the anterior rectus was closed with sutures."(b)(6) 2023- Patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with implant of Bard Soft Mesh (Device 2). Per op notes, "A left inguinal incision was made. The fascia was opened to the external ring. Scarring from the previous procedure and previous inguinal scar was identifie

  Patient problems: Hernia; Nerve Damage; Scar Tissue

  MAUDE report 50273984 ↗
• InjuryAug 12, 2026Patient-Device Incompatibility

  Per information provided:(b)(6)-2009 - Patient was diagnosed with small bowel obstruction and incarcerated ventral hernia thereby underwent open repair with the removal of Composix mesh (Device 1) and implant of two Bard Flat Mesh (Device 2 and 3). Per op notes, "Adhesiolysis was performed. The prior Composix mesh (Device 1) was removed which was located more on the lateral aspect of the incision from the hernia recurrence. Two separate pieces of Bard Flat Mesh (Device 2 and 3) were placed in an onlay fashion over the fascia using sutures." (b)(6)-2010 - Patient was diagnosed with incarcerated ventral hernia with wound abscess thereby underwent repair with removal of infected mesh (Device 2 and 3). Per op notes, "The ventral hernia was encountered, the hernia sac was separated from the fascia and the infected mesh. The mesh (Device 2 and 3) were excised from the abdominal wall. The infected mesh was separated from the extensive scar tissue attached to it, it was excised from the abdominal wall and removed. A biologic mesh was then placed."

  Patient problems: Abscess; Hernia; Scar Tissue; Unspecified Infection

  MAUDE report 50224486 ↗
• InjuryJul 31, 2026Patient-Device Incompatibility

  As reported in summary Per ANSM No (b)(4):Reportedly, "My pain relating to the hernia prosthesis began in (b)(6) 2025. I underwent surgery (Pre-shaped Mesh implant) on (b)(6) 2020 following the detection of an inguinal hernia in 2019. Apart from sporadic pain that tended to go away, I did not have any major problems with this prosthesis for the first four years. In (b)(6) 2025, following a sudden awkward movement, I experienced severe pain in my groin. As this pain was very similar to that of an inguinal hernia, I assumed it would eventually go away. This was not the case, however, and the pain became chronic."2026, Patient reported joint and muscle pain, fatigue and weakness. Patient attended the ED where neuropathic pain was diagnosed, CT scan revealed no recurrent hernia. Multiple investigations including MRI, abdominal and pelvic CT scan, blood tests and ultrasound, no diagnosis was identified to explain the hernia-related pain. Several specialists suggested the hernia prosthesis may be the cause. As of (b)(6) 2026, Patient reported severe chronic hernia pain radiating through the pelvic region, thigh and abdomen, severe and constant muscle and joint pain affecting quality of l

  Patient problems: Arthralgia; Discomfort; Fatigue; Hernia; Myalgia; Neuropathy

  MAUDE report 50101363 ↗
• InjuryJul 30, 2026Device Appears to Trigger Rejection

  Per information provided:On (b)(6) 2009 - Patient was diagnosed with two incisional hernias thereby underwent open repair with implant of Bard Flat Mesh (Device 1 and Device 2). Per op notes, ¿The midline fascial defect was approached first. An incision was made on the pervious scar. The hernia sac was identified and isolated from the fascia. A Bard Flat Mesh (Device 1) was placed on the defect and was secured with sutures. To repair the hernia in the kidney transplant scar (RLQ), the previous scar was excised and dissected the subcutaneous tissue down to fascia. The hernia sac was identified and isolated from the fascia. A Bard Flat Mesh (Device 2) was placed on the defect and secured with sutures." On (b)(6) 2009 - Patient was diagnosed with incarcerated incisional hernia and small bowel obstruction thereby underwent repair. Per op notes, "Noted the previously placed Bard Flat Mesh (Device 2) in the RLQ was intact with small bowel protruding through it. Adhesions were dissected free. A synthetic mesh was placed to the abdominal wall defect with tacks. The previously placed mesh (Device 1) was left on top of the defect and was still in place. And another synthetic mesh was placed

  Patient problems: Adhesion(s); Hernia; Obstruction/Occlusion

  MAUDE report 50083002 ↗

Other Davol Inc. products

• VENTRALEX6 models · 2,360 reports
• PerFix16 models · 1,718 reports
• VENTRALIGHT28 models · 1,284 reports · 2 recalls
• 3DMAX18 models · 1,067 reports
• VENTRIO18 models · 756 reports
• COMPOSIX18 models · 510 reports
• Hydro-Surg8 models · 307 reports · 2 recalls
• OPTIFIX5 models · 367 reports