3DMAX 0117310Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00801741031021), received between Apr 3, 2017 and Jun 19, 2025 — classified as 14 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Defective Device” (12 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE PREPARING TO INSERT 3DMAX LIGHT MESH INTO THE PATIENT, A PIECE OF THE EDGE BROKE OFF. IT WAS REPORTED THAT THE MESH WAS DISCARDED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292608 ↗
• InjuryMar 14, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, 3DMAX LIGHT MESH WAS IMPLANTED DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR ON (B)(6) 2013. IN 2023 THE PATIENT WAS NOT FEELING WELL AND UNDERWENT AN MIR AND CYSTOSCOPY, WHICH SHOWED EXPOSED MESH IN THE BLADDER. IN (B)(6) 2023, THE PATIENT UNDERWENT A PARTIAL RESECTION AND PARTIAL CYSTECTOMY.

  Patient problems: Erosion

  MAUDE report 18903219 ↗
• InjuryNov 29, 2023Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  Attorney alleges that the patient underwent surgery for implant of an unspecified Bard/Davol 3DMax on (b)(6)2021. As reported, the patient is making a claim for an adverse patient outcome against the 3DMax. 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 alleged that the patient had revision surgery on (b)(6)2023. It is also alleged that the patient experienced emotional distress and the device was defective.Addendum per additional information provided:(b)(6)2021 ¿ Patient was diagnosed with recurrent left inguinal hernia thereby underwent open repair with the implant of 3DMax Light Mesh (Device 1). Per op notes, ¿The left inguinal hernia was dissected out. A 3DMax Light Mesh (Device 1) was placed and secured to the pubic tubercle using tacks.¿ (b)(6)2023 ¿ Patient was diagnosed with recurrent bilateral inguinal hernia thereby underwent robotic repair with the removal of mesh (Device 1) and implant of 3DMax Light Meshes (Device 2, 3). Per op notes, ¿On left, the mesh was visualized beneath the peritoneum. The m

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

  MAUDE report 18225282 ↗
• MalfunctionNov 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, CRACKS WERE DISCOVERED IN THE 3DMAX LIGHT MESH BEFORE THE MESH WAS USED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18181965 ↗
• MalfunctionJul 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, WHEN OPENING THE 3DMAX LIGHT MESH PACKAGE DURING A HERNIA REPAIR PROCEDURE ON (B)(6) 2022, IT WAS FOUND THAT WHAT APPEARED TO BE AN INSECT WAS IN THE PACKAGE. THE DEVICE WAS NOT USED IN THE CASE. AS REPORTED, THERE WAS NO DAMAGE NOTED ON THE OUTER PACKAGE/INNER PACKAGE. ANOTHER 3DMAX LIGHT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14961786 ↗
• MalfunctionApr 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A PRODUCT SET UP ON (B)(6) 2022, THE BARD/DAVOL 3DMAX LIGHT MESH WAS NOTED TO BE TORN WHEN OPENED FROM THE PACKAGE. IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTICED ON INNER POUCH AND OUTER PACKAGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014010 ↗
• InjuryMar 25, 2022Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 3DMAX LIGHT MESH. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hematoma; Hernia; Insufficient Information

  MAUDE report 13912282 ↗
• MalfunctionAug 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2021, DURING INSERTION OF A BARD/DAVOL 3DMAX LIGHT MESH THROUGH A TROCAR, A PIECE OF MESH FELL INTO THE PATIENT'S ABDOMEN. IT IS REPORTED THAT IT IS UNCLEAR TO THE USER WHETHER THE PIECE OF MESH FOUND, TORE OFF THE MESH DURING INSERTION, OR IF IT WAS ON THE DEVICE AND FELL OFF DURING INSERTION. AS REPORTED, THE MESH PIECE AND DEVICE WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12274761 ↗
• InjuryFeb 17, 2021Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury

  MAUDE report 11337339 ↗
• InjuryNov 27, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX MESH ON (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury

  MAUDE report 10913040 ↗
• InjuryNov 18, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH, PERFIX PLUG AND MESH PRESHAPED ON (B)(6) 2013 AND/OR (B)(6) 2018 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 3DMAX LIGHT MESH AND MESH PRESHAPED. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE. ADDENDUM: ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX MESH, PERFIX PLUG AND BARD MESH (BARD FLAT MESH) ON (B)(6) 2013 AND/OR (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH AND BARD MESH (BARD FLAT MESH). IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury; Insufficient Information

  MAUDE report 10860679 ↗
• InjuryAug 24, 2020Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 10441067 ↗
• InjuryAug 14, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL 3DMAX MESH AND 3DMAX LIGHT MESH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH WHICH WAS IMPLANTED ON (B)(6) 2017. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Injury

  MAUDE report 10406022 ↗
• InjuryJan 23, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/ DAVOL 3DMAX MESH ON (B)(6) 2017. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX MESH. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 9621294 ↗
• InjuryJan 8, 2020Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESHES AND A VENTRALEX HERNIA PATCH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 3DMAX LIGHT MESHES WHICH WERE IMPLANTED ON (B)(6) 2017. ATTORNEY ALLEGES THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 9563380 ↗
• InjurySep 24, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH ON (B)(6) 2016. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S). AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BARD/DAVOL 3DMAX LIGHT MESH. AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Adhesion(s); Hernia; Injury

  MAUDE report 9111999 ↗
• MalfunctionSep 18, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE BARD 3DMAX LIGHT MESH WAS DAMAGED AFTER THE DOCTOR INSERTED THE MESH. AN IMAGE REVEALED THAT A CRACK WAS FOUND ON THE MESH EDGE. NO PATIENT INJURY. DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9081716 ↗
• InjuryJan 3, 2019Defective Device; No Apparent Adverse Event; Defective Device; No Apparent Adverse Event

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2013:THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH (2) (DEVICE #1 AND DEVICE #2). (B)(6) 2017: THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL SOFT MESH (DEVICE #3). THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE(S) (DEVICE #1, DEVICE #2 AND DEVICE #3). THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH(DEVICE #1 AND DEVICE #2) AND SOFT MESH (DEVICE #3). THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICES WERE DEFECTIVE.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 8214357 ↗
• InjuryDec 5, 2018Defective Device; Material Deformation; Patient Device Interaction Problem; Defective Device; Material Deformation; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY HAS ALLEGED THE FOLLOWING: (B)(6) 2014 - THE PATIENT UNDERWENT BILATERAL HERNIA REPAIR AND TWO (2) MEDIUM BARD/DAVOL 3DMAX LIGHT (DEVICES 1 AND 2) WERE IMPLANTED IN THE PATIENT DURING THIS REPAIR. (B)(6) 2018 - THE PATIENT UNDERWENT EXPLANT OF THE BARD/DAVOL 3DMAX LIGHT (DEVICE 1) FROM HIS LEFT GROIN. DURING THE SURGERY, ¿A PORTION OF THIS MESH THAT WAS INTRAPERITONEAL AND ROLLED INTO A BALL OR MESHOMA WITH VERY DENSE ADHESIONS OF THE SIGMOID COLON DIRECTLY TO THE MESH¿, ¿ONLY SIGNIFICANT ABNORMALITY WAS THE ROLLED UP MESH¿, & ¿SEROSAL INJURY NOTED ON THE WALL OF THE SIGMOID COLON THAT WAS UNAVOIDABLE BECAUSE OF THE SEVERE DENSITY OF ADHESIONS TO THE MESH¿. AS ALLEGED, THE BARD/DAVOL 3DMAX LIGHT IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE BARD/DAVOL 3DMAX LIGHT CAUSED SERIOUS INJURY AND HAD TO BE SURGICALLY REMOVED VIA INVASIVE SURGERY, AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE BARD/DAVOL 3DMAX LIGHT WAS INITIALLY IMPLANTED TO TREAT. AS REPORTED, THE PATIENT CONTINUES TO SUFFER SEVERE AND CHRONIC PAIN WHICH LIMITS HIS MOBILITY AND ACTIVITIES OF DAILY LIFE. ATTORNEY ALLEGES THAT THE3D MAX LIGHT (DEVIC

  Patient problems: Abdominal Pain; Adhesion(s); Disability; Injury

  MAUDE report 8132931 ↗
• InjuryApr 3, 2017No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING WAS REPORTED TO DAVOL. A PATIENT WHO WAS IMPLANTED WITH BARD/DAVOL 3D MAX LIGHT MESH TO TREAT INGUINAL HERNIA IN (B)(6) 2015 REPORTED INCREASING DISCOMFORT IN THE AREA OF THE REPAIR STARTING IN (B)(6) 2016. HIS SURGEON IDENTIFIED A RECURRENT HERNIA ON (B)(6) 2017. A PROCEDURE WAS PERFORMED ON (B)(6) 2017 AND IT WAS DISCOVERED THAT THE PATIENT DID NOT HAVE A RECURRENT HERNIA. THE SURGEON FOUND THAT THE PATIENT HAD A HERNIA ON THE OPPOSITE SIDE FROM WHERE THE ORIGINAL HERNIA HAD BEEN REPAIRED IN (B)(6) 2015 AND THAT THE PREVIOUSLY REPAIRED HERNIA DID NOT RECUR. THE 3DMAX LIGHT MESH REMAINS IN SITU. IN CONTACT WITH THE SURGEON HE REPORTED THAT HE HAS NOT SEEN THE PATIENT TO CONCLUDE THAT THE PAIN HAS RESOLVED. AS THE 3D MAX MESH REMAINS IMPLANTED AND HAS NOT BEEN COMPLETELY RULED OUT AS POSSIBLY CONTRIBUTOR TO PAIN THAT WAS ALLEGED AN MDR IS BEING FILED TO DOCUMENT THE EVENT.

  Patient problems: Hernia; Pain

  MAUDE report 6455219 ↗