3DMAX 0115312Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741030741), received between Jan 23, 2018 and Aug 1, 2025 — classified as 11 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Defective Device” (8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryAug 1, 2025Material Deformation; Material Deformation

  PER INFORMATION PROVIDED: (B)(6) 2004 ¿ PATIENT WAS DIAGNOSED WITH VENTRAL IN LOWER QUADRANTS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF ONE 3DMAX MESH (DEVICE #1) AND TWO SYNTHETIC MESH. PER OPERATIVE NOTES, ¿IN LEFT LOWER QUADRANT, HERNIA WAS NOTED AROUND THE PREVIOUSLY PLACED MESH. THE HERNIA WAS REDUCED AND 3DMAX MESH (DEVICE #1) WAS PLACED IN LEFT SIDE AND SUTURED. THE RIGHT LOWER QUADRANT HERNIA WAS REDUCED AND TWO SYNTHETIC MESHES WERE PLACED AND SUTURED.¿ (NOTE: THE PREVIOUSLY PLACED MESH WAS UNKNOWN). (B)(6) 2009 ¿ PATIENT WAS DIAGNOSED WITH INCARCERATED UMBILICAL HERNIA WITH PARTIAL BOWEL OBSTRUCTION THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF COMPOSIX E/X MESH (DEVICE #2). PER OPERATIVE NOTES, ¿INCARCERATED UMBILICAL HERNIA WITH OMENTUM AND COLON STUCKED IN HERNIA WAS NOTED. ADHESIONS WERE REDUCED AND COMPOSIX E/X MESH (DEVICE #2) WAS PLACED IN THE PERITONEAL CAVITY AND SUTURED.¿ (B)(6) 2014 - PATIENT WAS DIAGNOSED WITH RECURRENT LEFT INGUINAL HERNIA WITH CONTRACTED MESH (DEVICE #1) THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPIC REPAIR WITH REMOVAL OF MESH COMPOSIX E/X (DEVICE #1) AND PARTIAL REMOVAL OF 3DMAX MESH (DEVICE #2) AND IMPLANT OF UNKNOWN

  Patient problems: Adhesion(s); Hernia

  MAUDE report 22684893 ↗
• InjuryOct 1, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED ON (B)(6) 2024 THE PATIENT UNDERWENT LAPAROSCOPIC BILATERAL INDIRECT HERNIA REPAIR WITH THE IMPLANT OF TWO 3DMAX MESH (DEVICE #1 & DEVICE #2). IT WAS REPORTED THAT THE PATIENT EXPERIENCED ABDOMINAL DISTENSION, VOMITING AND INTESTINAL OBSTRUCTION ON (B)(6) 2024 THEREBY UNDERWENT TREATMENTS, BUT THERE WAS NO IMPROVEMENT. ON (B)(6) 2024, PATIENT UNDERWENT LAPAROSCOPIC EXPLORATION, DURING WHICH MOST OF THE PELVIC FASCIA WAS NECROTIC, LEFT, AND RIGHT SIDE OF THE HERNIA PATCHES WERE PARTIALLY ERODED AND TIGHT ADHESIONS FORMED AN OBSTRUCTION. THE 3DMAX MESH WAS REMOVED AND PARTIAL SMALL BOWEL RESECTION, SMALL BOWEL SIDE ANASTOMOSIS WAS PERFORMED, AND INTESTINAL ADHESIONS WERE LOOSENED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR TREATMENT FOLLOWING THE OPERATION. THIS FILE REPRESENTS DEVICE #1 (3DMAX - LEFT).

  Patient problems: Adhesion(s); Erosion; Necrosis; Obstruction/Occlusion

  MAUDE report 20346458 ↗
• MalfunctionApr 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE SURGEON NOTED 2 HOLES ON THE INFERIOR SIDE OF THE MESH AND SEALED EDGES WERE BROKEN AT ONE PLACE WHILE DEPLOYING A 3DMAX MESH. THERE WAS NO DAMAGE NOTED ON INNER OR OUTER PACKAGE AND THE BOX WAS COMPLETELY SEALED PRIOR TO OPENING. A 3DMAX LIGHT MESH WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215979 ↗
• InjuryNov 30, 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 MESH AND VENTRALEX ST PATCH ON 17-SEP-2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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: Insufficient Information; Pain

  MAUDE report 18236367 ↗
• InjuryMay 16, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ABOUT 5-10 YEARS POST-IMPLANT OF AN EXTRA-LARGE 3DMAX MESH (LEFT), PATIENT DEVELOPED LEFT SIDED PAIN AND STIFFNESS DUE TO SIGNIFICANT ADHESIONS. IT WAS REPORTED THAT THE SURGEON FELT BOTH GROINS, THERE WAS SIGNIFICANT STIFFNESS AND RIGIDITY ON THE LEFT COMPARED TO THE RIGHT SIDE. AS REPORTED, PATIENT UNDERWENT ROBOTIC PROCEDURE ON (B)(6) 2023 TO REMOVE THE MESH COMPLETELY DUE TO ADHESIONS.

  Patient problems: Adhesion(s); Pain

  MAUDE report 16939593 ↗
• InjuryJun 2, 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 UNSPECIFIED BARD/DAVOL 3DMAX AND PERFIX PLUG ON (B)(6) 2010 AND/OR (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD UNSPECIFIED INJURY ON (B)(6) 2021. 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: Insufficient Information; Pain

  MAUDE report 14575344 ↗
• InjuryJan 24, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED BARD/DAVOL 3DMAX ON (B)(6) 2018 AND (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. 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: Insufficient Information; Pain

  MAUDE report 13332536 ↗
• MalfunctionNov 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, A X-LARGE BARD/DAVOL 3DMAX LEFT MESH WAS INSERTED THROUGH A 12 MM TROCAR. ONCE THE MESH WAS PUSHED THROUGH COMPLETELY, IT WAS NOTED THAT THE MESH HAD TORN ALONG THE EDGES. AS REPORTED, THE MESH WAS REMOVED FROM THE PATIENT AND ANOTHER X-LARGE 3DMAX MESH WAS USED TO COMPLETE THE CASE. AS REPORTED, THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883915 ↗
• MalfunctionJun 24, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  AS PER NMPA (CHINA FDA): ON (B)(6) 2021, THE PATIENT UNDERWENT A HERNIA REPAIR USING A BARD/DAVOL 3DMAX MESH. AS REPORTED, THE OR NURSE CHECKED THE PRODUCT PACKAGING AND EXPIRATION DATE; NO ABNORMALITIES WERE OBSERVED AND THE MESH WAS SENT TO THE OPERATING TABLE FOR USE. WHEN THE USER MANUAL (INSTRUCTIONS-FOR-USE) WAS TAKEN OUT FROM THE PACKAGING BOX, IT WAS FOUND THAT THERE WAS A COCOON IN THE MANUAL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER MESH. THERE WAS NO PATIENT INJURY. ADDENDUM: ADDITIONAL INFORMATION PROVIDED STATES THAT THE PRODUCT HAD BEEN STORED AT THE USER FACILITY FOR A ¿LONG TIME.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12059166 ↗
• InjuryMay 12, 2021Defective 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 TWO UNSPECIFIED BARD/DAVOL 3DMAX MESHES ON (B)(6) 2006 AND (B)(6) 2011. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. IT IS ALSO ALLEGED THAT THE PATIENT HAD PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

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

  MAUDE report 11812339 ↗
• InjuryMay 8, 2019Defective Device; Material Deformation; Insufficient Device Problem Information; Defective Device; Material Deformation; Insufficient Device Problem Information

  ATTORNEY ALLEGES THAT ON (B)(6) 2013 AND (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #1) AND (DEVICE #3). IT IS ALLEGED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX (DEVICE #2). AS ALLEGED, ON (B)(6) 2016, (B)(6) 2016, AND (B)(6) 2018, THE PATIENT HAD UNSPECIFIED INJURIES RELATED TO A DEFECT IN THE PERFIX PLUG (DEVICE #1) AND (DEVICE #3) AND 3DMAX (DEVICE #2), AND UNDERWENT REVISION SURGERIES. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE TWO (2) PERFIX PLUG (DEVICE #1) AND (DEVICE #3) AND THE 3DMAX (DEVICE #2). AS REPORTED, THE 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."

  Patient problems: Adhesion(s); Disability; Injury; Nerve Damage; Pain

  MAUDE report 8592561 ↗
• InjuryNov 21, 2018Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: ON (B)(6) 2014: THE PATIENT UNDERWENT LEFT INGUINAL HERNIA REPAIR. A BARD/DAVOL 3DMAX WAS IMPLANTED IN THE PATIENT DURING THIS REPAIR. NI/NI/NI: THE PATIENT BEGAN SUFFERING INCREASING PAIN IN THE SITE WHERE HE HAD THE SURGERY. ON (B)(6) 2016: THE PATIENT UNDERWENT RECURRENT LEFT INGUINAL HERNIA REPAIR. THE PHYSICIAN NOTED THAT THE HERNIA RECURRED BOTH DIRECTLY AND INDIRECTLY. THE PATIENT CONTINUES TO EXPERIENCE PAIN AT HE SITE WHICH SIGNIFICANTLY IMPAIRS HIS QUALITY OF LIFE. THE MESH IMPLANTED IN THE PATIENT FAILED TO REASONABLY PERFORM AS INTENDED. THE PRODUCT CAUSED SERIOUS INJURY AND NECESSITATED ADDITIONAL INVASIVE SURGERY TO REPAIR THE HERNIA THAT THE MESH WAS INITIALLY IMPLANTED TO TREAT. THE PATIENT HAS BEEN INJURED, SUSTAINED SEVERE PAIN, SUFFERING, ANXIETY AND IMPAIRMENT.

  Patient problems: Disability; Hernia; Injury

  MAUDE report 8097209 ↗
• InjuryMar 14, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE PATIENT'S ATTORNEY HAS ALLEGED. ON (B)(6) 2014 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED 3DMAX MESH (DEVICE 1) AND (DEVICE 2). AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

  Patient problems: Disability; Hernia; Nerve Damage; Pain

  MAUDE report 7339445 ↗
• InjuryJan 23, 2018Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem; Defective Device; Insufficient Device Problem Information; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2013: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF AN INGUINAL HERNIA. A 3DMAX, REFERENCE NUMBER 0115312 AND LOT NUMBER HUXJ0019 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2015: THE PATIENT "UNDERWENT AN ADDITIONAL SURGERY TO REPAIR THE HERNIA DEFECT AND REMOVE IT." AS REPORTED BY THE ATTORNEY, THE 3DMAX USED IN THE PATIENT'S HERNIA REPAIR SURGERY FAILED, RESULTING IN MUCH PAIN AND SUFFERING, DOCTOR VISITS, SUBSEQUENT PROCEDURES AND WAS INJURED SEVERELY AND PERMANENTLY. IT IS ALLEGED THAT THE PATIENT HAS SUFFERED AND WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE 3DMAX MESH.

  Patient problems: Disability; Hernia; Pain

  MAUDE report 7213830 ↗