PerFixRecalls & reported problems across all models

We found 16 models of PerFix by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 1,718 adverse event reports in the FDA's MAUDE database, received between Mar 15, 2013 and Sep 30, 2026 — classified as 9 deaths, 1,668 injuries, 41 malfunctions.

The most frequently reported specific device problem is “Defective Device” (1,433 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 PerFix problems

PerFix models

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

• PerFix 0112770

  Mesh, surgical, polymeric
  376 reports
• PerFix 0112760

  Mesh, surgical, polymeric
  1 death339 reports
• PerFix 0112780

  Mesh, surgical, polymeric
  1 death230 reports
• PerFix 0112970

  Mesh, surgical, polymeric
  1 death228 reports
• PerFix 0112750

  Mesh, surgical, polymeric
  163 reports
• PerFix 0112980

  Mesh, surgical, polymeric
  2 deaths121 reports
• PerFix 0112960

  Mesh, surgical, polymeric
  3 deaths106 reports
• PerFix 0112950

  Mesh, surgical, polymeric
  38 reports
• PerFix 0117070

  Mesh, surgical, polymeric
  25 reports
• PerFix 0117060

  Mesh, surgical, polymeric
  22 reports
• PerFix 0117170

  Mesh, surgical, polymeric
  21 reports
• PerFix 0117080

  Mesh, surgical, polymeric
  1 death19 reports
• PerFix 0117180

  Mesh, surgical, polymeric
  13 reports
• PerFix 0117050

  Mesh, surgical, polymeric
  8 reports
• PerFix 0117160

  Mesh, surgical, polymeric
  8 reports
• PerFix 0117150

  Mesh, surgical, polymeric
  1 report

Recent PerFix 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

  Patient problems: Hernia

  MAUDE report 50949395 ↗
• InjurySep 30, 2026Patient-Device Incompatibility

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50949388 ↗
• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2008: Patient was diagnosed with indirect and direct right inguinal hernia thereby underwent open repair with the implant of PerFix Plug (right - Device 1, left - Device 2). Per op notes, ¿On right groin, there was a direct inguinal hernia consisting of a direct hernia sac which was dissected away from the cord structures. Mild indirect hernia was noted. A medium sized Marlex Mesh was placed in the direct defect and sutured. A small mesh plug was placed in indirect defect and sutured to the shelving edge of inguinal ligament and a precut preshaped keyhole patch was placed on the floor of the inguinal canal.¿ (b)(6) 2013 ¿ Patient had right lower quadrant pain.(b)(6) 2013 ¿ Patient had pain thereby underwent ilioinguinal nerve block.

  Patient problems: Pain

  MAUDE report 50944372 ↗
• InjurySep 30, 2026Patient-Device Incompatibility

  Per information provided:On (b)(6) 2005 - Patient was diagnosed with bilateral inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1 ¿ Left and Device 2 ¿ Right). Per operative notes, ¿A transverse supraumbilical incision was made on both sides and carried down to the subcutaneous tissue. On the left side of the inguinal region a hernia sac was identified, which was removed. A PerFix Plug (Device 1) was placed into the right inguinal region and secured it with sutures. Another incision was made into the right side of the inguinal region. There was a hernia sac identified. The hernia sac was dissected out. A PerFix Plug (Device 2) was placed into the right inguinal floor and secured it with sutures.¿On (b)(6) 2013 - Patient was diagnosed with bilateral inguinal hernia, adhesion thereby underwent laparoscopic repair with implant of synthetic mesh. Per operative notes, ¿An incision was made into the inguinal region through previous incision site. There were direct inguinal hernias which were both recurrences, as previously placed PerFix Plug (Device 1 and 2) was identified. During right-sided dissection, the PerFix Plug (Device 2) was adhered to the perit

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50942742 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Patient problems: Ambulation or Postural Difficulties; Fatigue; Muscle Weakness/Atrophy; Pain

  MAUDE report 50900126 ↗
• InjurySep 25, 2026Material Deformation

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 50899360 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50898523 ↗
• InjurySep 25, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2010 - Patient was diagnosed with right inguinal hernia thereby underwent open repair with the implant of PerFix Plug (Device 1). Per op notes, "An incision to the right groin, a large PerFix Plug (Device 1) was placed to the inguinal floor using sutures."(b)(6) 2011 - Patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with the implant of two PerFix Plugs (Device 2 and 3). Per op notes, "An Incision was carried down through the previous incision to the subcutaneous tissue. Identification of the femoral vessels, there was a defect laterally to the cord for which the extra large PerFix Plug (Device 2) was placed. Upon palpation a femoral defect was palpated and a small PerFix Plug (Device 3) was placed in the defect and sutured."(b)(6) 2021 - Patient was diagnosed with recurrent right inguinal hernia thereby underwent repair with removal of all previous meshes (Device 1, 2 and 3) and implant of 3DMax Mid Mesh (Device 4). Per op notes, "The peritoneum was densely adherent to the previous mesh plug, which was actually intraabdominal. Able to dissect this off the plug and separate the peritoneum from the cord structur

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50895526 ↗
• InjurySep 3, 2026Patient-Device Incompatibility

  Per information provided:On 23-Sep-2015 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of PerFix Plug (Device 1 and 2). Per op notes, "On the right inguinal region, an indirect and a large direct hernia sac were noted and separated from the cord structures. A PerFix Plug (Device 1) with onlay patch was placed and sutured. On the left inguinal region, large direct and indirect hernia defects were noted and reduced. A PerFix Plug (Device 2) with onlay patch was placed and sutured."On (b)(6) 2018 - Patient was diagnosed with chronic bilateral groin pain thereby underwent open repair with excision of PerFix Plug (Device 1 and 2). Per op notes, "On the right inguinal region, the cord structures were densely adherent to the old mesh (Device 1) were taken down. The cord structures were mobilized. The old mesh (Device 1) was excised and removed. On the left inguinal region, the mesh (Device 2) was densely adherent to the cord structures were taken down. The old mesh (Device 2) was excised and removed. Both defects on right and left inguinal region were closed with sutures."

  Patient problems: Adhesion(s); Pain

  MAUDE report 50588123 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2015 - Patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1 and 2). (b)(6) 2016 - Patient was diagnosed with right ilioinguinal neuralgia and right groin pain thereby underwent ilioinguinal nerve block on the right inguinal region. (b)(6) 2016 - Patient was diagnosed with ilioinguinal neuralgia thereby underwent ilioinguinal nerve block was performed. (b)(6) 2016 - Patient was diagnosed with right groin/ inguinal pain. Patient has since developed recurrent of his pain at the site.

  Patient problems: Neuralgia

  MAUDE report 50459858 ↗
• InjuryAug 26, 2026Patient-Device Incompatibility

  Per information provided:(b)(6) 2008 - Patient was diagnosed with bilateral inguinal hernias thereby underwent open repair with implant of PerFix Plug (Device 1 and 2). Per op notes, ¿A left groin incision was made. The inguinal canal was dissected out. The indirect sac was also excised. A small indirect defect was noted. A PerFix Plug (Device 1) was placed and secured with suture. The floor of the canal was reconstructed with mesh sewn to the pubic tubercle. Similar repair was performed to the right groin. A small indirect sac was identified and excised. A PerFix Plug (Device 2) was placed and the floor was reconstructed with the same mesh and secured with suture.¿ (b)(6) 2012 - Patient was diagnosed with recurrent right inguinal hernia thereby underwent open repair with partial excision of PerFix Plug (Device 2) and implant of synthetic mesh and Bard Mesh Pre-Shaped (Device 3). Per op notes, ¿An incision was made through the old scar. The old mesh was fused to the underside of the external oblique and was freed up. The prior mesh (Device 2) was noted in the direct area. An obvious direct hernia defect was noted on palpation. The PerFix Plug (Device 2) was partially resected. The

  Patient problems: Hernia

  MAUDE report 50458144 ↗
• InjuryAug 25, 2026Material Deformation

  Per information provided:(b)(6) 2013- Patient was diagnosed with recurrent right inguinal hernia, left inguinal hernia, thereby underwent open repair with implant of PerFix Plugs (Device 1 and 2). Per op notes, "In the right inguinal region, previously placed mesh was found pulled away and there was hernia with omentum. The omentum was reduced an dwas repaired by placing PerFix Plug (Device 1) and sutured. Then on the left inguinal region, direct hernia was identified and was dissected. An extra large PerFix Plug (Device 2) was placed and sutured." (b)(6) 2016- Patient was diagnosed with recurrent bilateral inguinal hernias, thereby underwent robotic repair with implant of synthetic mesh. Per op notes, "Some adhesions in the right inguinal area along with indirect hernia was identified. There was a recurrent direct hernia and the PerFix Plug (Device 1) was found pulled away from pubic tubercle area. A synthetic mesh was placed covering the entire inguinal canal and sutured. There was a large piece of mesh (PerFix Plug-Device 2) was found crumpled up and stuck to the spermatic cord. There was a recurrent indirect hernia. Another synthetic mesh was then placed and sutured."

  Patient problems: Hernia

  MAUDE report 50427833 ↗
• InjuryAug 17, 2026Migration

  Per information provided: On (b)(6) 2017- Patient was diagnosed with right femoral hernia thereby underwent open repair with implant of PerFix Plug (Device 1 and Device 2). Per op notes, "A skin incision was made on the previous C-section incision. External oblique was opened. A femoral hernia was identified. It was dissected out of the canal. A PerFix Plug (Device 1) was placed into the canal in the location of the defect and secured with sutures. The proximal defect ends another PerFix Plug (Device 2) were placed into the opening and anchored in place with sutures together for better coverage." On (b)(6) 2021- Patient was diagnosed with left inguinal hernia, recurrent right inguinal hernia, umbilical hernia and pain in right groin thereby underwent robotic assisted laparoscopic repair and open repair for umbilical hernia with partial explant of PerFix Plug (Device 1 and Device 2) and implant of Bard Flat Mesh (Device 3 and Device 4). Per op notes, "In the left groin a small indirect defect was identified. On the left a peritoneal incision was made in a transverse direction. The peritoneum was dissected and the hernia sac was reduced. A large lipoma which was adherent to the round

  Patient problems: Adhesion(s); Hernia; Pain

  MAUDE report 50272594 ↗
• MalfunctionAug 14, 2026Device Contamination with Chemical or Other Material

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50258107 ↗
• InjuryJul 30, 2026Material Deformation

  Per information provided:On (b)(6) 2013 - Patient was diagnosed with recurrent ventral incisional hernia and left inguinal hernia thereby underwent open recurrent ventral incisional hernia repair with the implant of Ventrio Mesh (Device 1) and left inguinal hernia repair with the implant of PerFix Plug (Device 2). Per op notes, "A midline incision was made, Ventrio Mesh (Device 1) was placed towards the abdominal cavity using prolene sutures. Attention to the left inguinal hernia, where a left incision was performed. A PerFix Plug (Device 2) was placed to the abdomen using sutures." On (b)(6) 2016 - Patient was diagnosed with recurrent ventral incisional hernia hereby underwent laparoscopic repair with the removal of both meshes (Device 1 and 2) and implant of Ventrio ST Mesh (Device 3). Per op notes, "Patient had recurrent ventral incisional hernia which had been repaired previously with two meshes. Extensive intra-abdominal adhesions were taken down. The more recent mesh (Device 1 and 2) which had been placed appeared to have folded over on itself. Both meshes (Device 1 and 2) were removed from the abdominal wall. A Ventrio ST Mesh (Device 3) was secured to the old mesh inferiorl

  Patient problems: Adhesion(s); Hernia

  MAUDE report 50078391 ↗

Other Davol Inc. products

• VENTRALEX6 models · 2,360 reports
• BARD25 models · 1,538 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