3DMAXRecalls & reported problems across all models
Davol Inc. · 18 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,067
- Deaths reported
- 0
- Injuries reported
- 849
- Recalls
- 0
We found 18 models of 3DMAX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 1,067 adverse event reports in the FDA's MAUDE database, received between Jul 13, 2015 and Sep 30, 2026 — classified as 849 injuries, 218 malfunctions.
The most frequently reported specific device problem is “Defective Device” (577 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
Reports received per month, all models
Most reported 3DMAX problems
Device problems
- Defective Device577
- Patient-Device Incompatibility451
- Insufficient Device Problem Information411
- Patient Device Interaction Problem326
- Material Split, Cut or Torn135
- Material Deformation96
- Migration82
- Device Contamination with Chemical or Other Material31
Patient problems
- Pain554
- Hernia444
- Injury327
- Disability282
- Adhesion(s)214
- No Clinical Signs, Symptoms or Conditions189
- Insufficient Information160
- Nerve Damage101
3DMAX models
18 models, most reported first. Each model has its own page with its reports, recalls and device details.
- 3DMAX 0115321Mesh, surgical, polymeric260 reports
- 3DMAX 0115311Mesh, surgical, polymeric209 reports
- 3DMAX 0115310Mesh, surgical, polymeric125 reports
- 3DMAX 0115320Mesh, surgical, polymeric118 reports
- 3DMAX 0117321Mesh, surgical, polymeric96 reports
- 3DMAX 0117311Mesh, surgical, polymeric95 reports
- 3DMAX 0117320Mesh, surgical, polymeric28 reports
- 3DMAX 0116321Mesh, surgical, polymeric26 reports
- 3DMAX 0115322Mesh, surgical, polymeric22 reports
- 3DMAX 0117310Mesh, surgical, polymeric20 reports
- 3DMAX 0116311Mesh, surgical, polymeric18 reports
- 3DMAX 0115312Mesh, surgical, polymeric14 reports
- 3DMAX 0117322Mesh, surgical, polymeric11 reports
- 3DMAX 0116322Mesh, surgical, polymeric10 reports
- 3DMAX 0117312Mesh, surgical, polymeric7 reports
- 3DMAX 0116312Mesh, surgical, polymeric6 reports
- 3DMAX 0116310Mesh, surgical, polymeric1 report
- 3DMAX 0116320Mesh, surgical, polymeric1 report
Recent 3DMAX adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Deformation
Patient problems: Hematoma; Pain
MAUDE report 50950935 ↗InjurySep 30, 2026Patient-Device Incompatibility
Patient problems: Ambulation or Postural Difficulties; Depression; Dyspareunia; Fatigue; Hernia; Muscle Weakness/Atrophy; Pain; Unspecified Gastrointestinal Problem
MAUDE report 50950925 ↗InjurySep 30, 2026Patient-Device Incompatibility
Patient problems: Cognitive Changes; Fatigue; Muscle Weakness/Atrophy; Pain; Unspecified Gastrointestinal Problem
MAUDE report 50950923 ↗InjurySep 25, 2026Patient-Device Incompatibility
Patient problems: Pain
MAUDE report 50902834 ↗InjurySep 23, 2026Patient-Device Incompatibility
Patient problems: Adhesion(s); Unspecified Infection
MAUDE report 50873065 ↗InjurySep 21, 2026Material Deformation
Per information provided:On (b)(6) 2015 - Patient was diagnosed with bilateral direct inguinal hernias thereby underwent open repair with implant of 3DMax Light Mesh (Device 1 - Left and Device 2 - Right). Per operative notes, "An incision was made into the left inguinal region. The hernia sac was dissected out. A 3DMax Light Mesh (Device 1) was placed into the left inguinal floor and secured it with sutures. Another incision was made into the right groin. The hernia sac was dissected out. A 3DMax Light Mesh (Device 2) was placed into the right inguinal region and secured it with sutures."Attorney alleges that patients had hernia recurrence, nerve damage, mesh shrinkage and pain.
Patient problems: Hernia; Nerve Damage; Pain
MAUDE report 50837738 ↗InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Adhesion(s); Hernia
MAUDE report 50620008 ↗InjurySep 3, 2026Patient-Device Incompatibility
Patient problems: Discomfort; Pain
MAUDE report 50593013 ↗InjurySep 3, 2026Material Deformation
Per information provided:On (b)(6) 2020 - Patient was diagnosed with bilateral inguinal hernia thereby underwent robotic assisted repair with implant of 3DMax Mesh (Device 1 and 2). Per op notes, "An incision was made. Omental adhesions were taken down. Left peritoneum was taken down and identified both the indirect and direct defect which were reduced from the spermatic cord. A large piece of 3DMax Mesh (Device 1) was placed and the peritoneum was secured with suture. On the right side, the peritoneum was taken down in a similar fashion and a defect was noted in a direct position. A medium piece of 3DMax Mesh (Device 2) was placed and secured the peritoneum with suture."On (b)(6) 2020 - Patient was diagnosed with adhesions to the site of bilateral inguinal hernia thereby underwent robotic assisted repair with partial excision of 3DMax Mesh (Device 2). Per op notes, "Old incision site was used. Extensive adhesions between the omentum and bowel to both inguinal hernia repair sites were noted. Adhesions were taken down. Well incorporated mesh was noted in the left inguinal repair site. The right side had an area of wrinkles in its lateral portion and these were attached to the adhesi
Patient problems: Adhesion(s); Inflammation; Nerve Damage; Pain
MAUDE report 50584841 ↗MalfunctionAug 26, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456679 ↗InjuryAug 26, 2026Patient-Device Incompatibility
Per information provided:(b)(6)2013 - Patient was diagnosed with right inguinal hernia thereby underwent open repair with implant of PerFix Plug (Device 1). Per op notes, ¿Incision was made in the right groin. The cord contents were reduced. The contents of the hernia sac were reduced. The hernia sac was dissected free. There was a small defect in the ring. A PerFix Plug (Device 1) was placed and sutured. A patch was placed in the floor and sutured.¿ (b)(6)2014 - Patient was diagnosed with recurrent right sided inguinal hernia and left inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax (Device 2 and 3). Per op notes, ¿On the right inguinal region, a recurrent indirect hernia sac was identified and reduced. The old mesh (Device 1) was stuck in the hernia sac was dissected. No evidence of direct or femoral hernia. There was preperitoneal fat in the femoral space was reduced. A 3DMax (Device 2) was placed and tacked to cooper's ligament. On the left inguinal region, an indirect hernia sac was identified and reduced. A 3DMax (Device 3) was placed and tacked to cooper's ligament.¿ (b)(6)2015 ¿ Patient had right lower quadrant pain for six months and right groin
Patient problems: Pain; Seroma
MAUDE report 50449031 ↗InjuryAug 25, 2026Patient-Device Incompatibility
Per information provided: (b)(6) 2010 - Patient was diagnosed with incarcerated left inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax Mesh (Device 1 and Device 2 - Left). Per operative notes, "An incision was made in the left lateral abdomen. The left inguinal hernia sacs were dissected out. A 3DMax Mesh (Device 1) was placed into the peritoneal cavity and secured it with sutures. Another 3Dmax Mesh (Device 2) was placed anteriorly along the upper of the (Device 1) with good coverage and secured it with sutures." (b)(6) 2013 - Patient was diagnosed with recurrent left inguinal hernia, hematoma thereby underwent open repair with implant of synthetic mesh. Per operative notes, "A curvilinear incision was made along the skin lines in the left lower quadrant just over the inguinal ligament. The hernia sac was dissected out. There was a large bulky hematoma which was removed. It speared that the new defect was posterior to the previously placed 3DMax Mesh (Device 1 and Device 2). A synthetic mesh was placed into the left groin and secured it with sutures."
Patient problems: Hematoma; Hernia
MAUDE report 50431561 ↗InjuryAug 12, 2026Patient-Device Incompatibility
Per information provided:(b)(6) 2014- Patient was diagnosed with recurrent left inguinal hernia, right inguinal hernia, recurrent ventral hernia, thereby underwent robotic assisted laparoscopic repair with implant of Ventralight ST Using Echo PS (Device 1). Per op notes, "The previously placed synthetic mesh was noted on the anterior abdominal wall. Bilateral inguinal hernias were identified. The hernia sac was identified and dissected. A large 3DMax Mesh (Device 1) was then placed in the preperitoneal space in left inguinal region and was sutured. A large 3DMax Mesh (Device 2) was then placed into preperitoneal space in right inguinal region and was sutured. A hernia defect in the midline of the anterior abdominal wall was identified, and a Ventralight ST Using Echo PS (Device 3) was placed in the abdominal region and was sutured."(b)(6) 2017- Patient was diagnosed with recurrent small bowel obstruction, recurrent ventral hernia, thereby underwent open repair with explant of Ventralight ST Using Echo PS (Device 3), implant of synthetic mesh. Per op notes, "An old midline scar was removed. The previous ventral hernia mesh (Device 3) was encountered and excised. Adhesiolysis was per
Patient problems: Hernia; Obstruction/Occlusion
MAUDE report 50226234 ↗InjuryJul 30, 2026Migration
Per information provided:On (b)(6) 2022- Patient was diagnosed with bilateral inguinal hernia thereby underwent laparoscopic repair with implant of 3DMax Meshes (Device 1 and 2). Per op notes, "A large indirect hernia sac was identified in right inguinal region and dissected. A 3DMax Mesh (Device 1) was then placed and sutured. There was a direct hernia and an indirect sac in the left inguinal region and was dissected. A 3DMax Mesh (Device 2) was then placed and sutured." On (b)(6) 2022- Patient was diagnosed with infected mesh bilateral groins, thereby underwent laparoscopic repair with explant of 3DMax Meshes (Device 1 and 2). Per op notes, "In the left inguinal region, Adhesions from the anterior abdominal wall was identified and the 3DMax Mesh (Device 2) was found free floating and was excised. In right inguinal region, most part of 3DMax Mesh (Device 2) was found to be inflamed and infected. Abscess through rectus muscle was also noted and the 3DMax Mesh (Device 1) was completely excised."
Patient problems: Pain; Unspecified Infection
MAUDE report 50083001 ↗MalfunctionJul 28, 2026Device Contamination with Chemical or Other Material
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50060196 ↗
Other Davol Inc. products
All Davol Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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