3DMAX 0116322Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741200793), received between Aug 17, 2021 and Jun 10, 2026 — classified as 5 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2026Patient-Device Incompatibility

  AS REPORTED, THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR WITH IMPLANTATION OF TWO 3DMAX MID MESH (DEVICE #1 AND DEVICE #2) ON (B)(6) 2026 AND THE MESH "FAILED TO BE INSTALLED PROPERLY ON THE PATIENT." "DOCTOR ORDERED A PELVIS CT IN (B)(6) 2026 DUE TO PATIENT COMPLAINTS. FOUND - LARGE BILATERAL INGUINAL HERNIAS. THE LEFT INGUINAL HERNIA CONTAINS LOOP OF SIGMOID COLON. THERE ARE LARGE CYSTS IN BOTH INGUINAL HERNIAS." AS REPORTED IN FOLLOW UP WITH NURSE, "GIANT RIGHT INGUINAL HERNIA CONTAINING LOOPS OF SMALL INTESTINE, REDUCIBLE. SLIGHTLY SMALLER BUT STILL GIANT LEFT INGUINAL HERNIA CONTAINING ADIPOSE TISSUE AND OMENTUM. SURGEON REPORTS THAT HE HAD MET WITH LOCAL BARD MESH REP TO DISCUSS SPECIFIC TECHNIQUES NECESSARY FOR THIS MESH ¿ REP VALIDATED THE TECHNIQUES THAT SURGEON DESCRIBED WAS CORRECT. SURGEON USED A ROBOTIC APPROACH USING DAVINCI XI ROBOT. FROM SURGEON OPERATIVE NOTE¿¿RIGHT ¿ATTEMPTED TO PUT AN OH SYMMETRIC PDS SUTURE TO CLOSE THE HERNIA FROM THE MEDIAL TO LATERAL DIRECTION HOWEVER THERE WAS SIGNIFICANT TENSION THEREFORE ONLY 1-1 ½ CM SEGMENT WAS REAPPROXIMATED. THE MESH WAS THEN SECURED WITH DIRECT PRESSURE AS WELL AS 2 INTERRUPTED 3-0 VICRYL SUTURES. ONE WAS P

  Patient problems: Cyst(s); Hernia

  MAUDE report 25453152 ↗
• InjuryMar 11, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH 3DMAX MID MESH (DEVICE #1) (CAT# 0116322; LOT# HUGQAB10) DURING AN INGUINAL HERNIA REPAIR SURGERY ON (B)(6) 2022. IT WAS ALLEGED THAT THE PATIENT HAD RECURRENT RIGHT INGUINAL HERNIA AND THEREBY UNDERWENT REPAIR WITH THE IMPLANT OF BARD FLAT MESH (DEVICE #2) (CAT# 0112680; LOT# HUFY0486) ON (B)(6) 2023, DURING THE PROCEDURE THE SURGEON NOTED THAT THE "SCARRING AROUND THE HERNIA SAC AND THE CORD STRUCTURES". IT WAS ALSO ALLEGED THAT PATIENT EXPERIENCED HERNIA RECURRENCE, CHRONIC PAIN AND ADDITIONAL SURGICAL INTERVENTION WHICH HAVE IMPAIRED DAILY ACTIVITIES POST IMPLANT OF BOTH MESHES. 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 DEVICE WAS DEFECTIVE. THIS FILE REPRESENTS 3DMAX MID (DEVICE #1).

  Patient problems: Hernia; Pain; Scar Tissue

  MAUDE report 21571388 ↗
• InjuryFeb 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR WITH THE IMPLANT OF 3DMAX MID MESHES (DEVICE #1 - LEFT & DEVICE #2 - RIGHT) ON (B)(6) 2024 AND EXPERIENCED ALLERGIC REACTION POST IMPLANT. IT WAS REPORTED THAT PATIENT EXPERIENCED SYMPTOMS OF FATIGUE, JOINT TENDERNESS AND DISCOMFORT IN THE GROIN AREA WHERE THE MESHES WERE PLACED AND NO TREATMENT WAS PROVIDED TO THE PATIENT CURRENTLY. IT WAS ALSO REPORTED THAT THE SURGEON IS PLANNING TO PERFORM A REACTIVITY TEST WITH THE 3DMAX MID MESH SAMPLE ON (B)(6) 2025. ADDENDUM: THE MESH SAMPLE WAS APPLIED TO THE PATIENT ON (B)(6) 2025 FOR REACTIVITY TESTING. THE FINAL READING WAS ON (B)(6) 2025 AND SHOWED NO REACTION TO THE 3DMAX MID MESH. DOCTOR ADVISED PATIENT TO LEAVE MESH IN PLACE, AS HER SYMPTOMS ARE NOT RELATED TO THE MESH. THIS FILE REPRESENTS DEVICE #2.

  Patient problems: Discomfort; Fatigue

  MAUDE report 21371240 ↗
• InjuryOct 30, 2024Material Deformation; Material Deformation

  AS PER MEDWATCH FORM (MW5159457), "PATIENT HAD ROBOT-ASSISTED BILATERAL HERNIA REPAIR WITH MESH ON (B)(6) 2024. PATIENT RETURNED TO HOSPITAL TWO DAYS LATER WITH RIGHT SWOLLEN GROIN AND PAIN. THE X-RAY REVEALED RECURRENCE OF HIS RIGHT SCROTAL INGUINAL HERNIA. PATIENT REQUIRED REPEAT SURGERY ON (B)(6) 2024, AND THE MESH WAS FOUND FOLDED UPWARDS. MESH SURGICAL 3DMAX 17X12CM 7X5IN RIGHT MID XL INGUINAL - LOG3209447."

  Patient problems: Hernia; Pain; Swelling/ Edema

  MAUDE report 20567351 ↗
• MalfunctionAug 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A ROBOTIC PROCEDURE, WHEN THE SURGEON ROLLED THE 3DMAX MID MESH IN PREPARATION TO PLACE, THE SEALED EDGE CRACKED IN MULTIPLE PLACES. IT WAS REPORTED THAT THE EDGE OF THE MESH WAS BRITTLE AND PEELING OFF. THE PROCEDURE WAS COMPLETED WITH A FLAT MESH SHEET. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17588746 ↗
• MalfunctionAug 21, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A ROBOTIC PROCEDURE, WHILE ROLLING THE 3DMAX MID MESH IN PREPARATION TO PLACE THROUGH AN 8MM TROCAR, THE SURGEON FOUND CRACKING OF THE SEALED EDGE OF THE DEVICE. IT WAS REPORTED THAT EDGE OF THE MESH WAS BRITTLE AND PEELING OFF. IT WAS REPORTED THAT THE SAME ISSUE PERSISTED IN MULTIPLE DEVICES. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3DMAX MID MESH WHICH DID NOT CRACK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17588740 ↗
• MalfunctionJul 13, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  AS REPORTED, WHEN THE 3DMAX MID RIGHT MESH WAS BROUGHT INTO A CASE FROM INVENTORY AND THE CARTON OPENED IT DID NOT CONTAIN THE IMPLANT WITHIN A STERILE POUCH. AS REPORTED THE MESH WITHIN THE CARTON WAS CONTAINED INSIDE OF THE CLAM SHELL TRAY BUT IT WAS NOT WITHIN THE TYVEK STERILE POUCH. THE MESH WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317215 ↗
• MalfunctionMar 10, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED THE CUSTOMER WAS USING THE 3D MAX MID MESH AND WHEN THEY ROLLED IT AROUND THE TROCAR FOR INSERTION IT CRACKED ALONG THE INFERIOR EDGE OF THE MESH. IN FOLLOW UP IT WAS REPORTED THAT, DURING A ROBOTIC RIGHT FEMORAL HERNIA REPAIR, UPON OPENING THE PACKAGE OF 3DMAX MID MESH, THE EDGE OF THE MESH WAS NOTED TO BE CRACKED. IT WAS REPORTED THAT THE MESH WAS NEVER ROLLED OR INSERTED INTO THE TROCAR. AS REPORTED A NEW 3DMAX MID MESH WAS USED FOR THE CASE WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522721 ↗
• MalfunctionJun 24, 2022Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A ROBOTIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, A BARD/DAVOL 3DMAX MID MESH WHICH EXPIRED ON 28-APR-2022 WAS IMPLANTED IN A PATIENT. IT WAS REPORTED THAT THE MESH HAS BEEN LEFT IMPLANTED AND THE PATIENT HAS NOT RECEIVED ANY ADDITIONAL MEDICAL/SURGICAL TREATMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800908 ↗
• InjuryAug 17, 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 UNSPECIFIED BARD/DAVOL 3DMAX MESH AND VENTRALIGHT ST ON (B)(6) 2019 AND/OR (B)(6) 2021. 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 12332877 ↗