3DMAX 0116311Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00801741200755), received between May 12, 2022 and Apr 23, 2026 — classified as 9 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 23, 2026Entrapment of Device

  AS REPORTED, THE PATIENT UNDERWENT LAPAROSCOPIC INGUINAL HERNIA REPAIR WITH 3DMAX MID MESH, DURING SURGERY THE MESH STUCK TO ITSELF AND GOT WRAPPED IN A FOLD OF PERITONEUM. THE MESH COULD NOT BE LOCATED LAPAROSCOPICALLY, SO THEY HAD TO EXTEND THE INCISION TO FIND IT MANUALLY USING PALPATION. THE MESH WAS SUBSEQUENTLY REMOVED AND A NEW MESH WAS IMPLANTED TO COMPLETE THE PROCEDURE. AS PER THE SURGEON, "I DON'T THINK THE ISSUE WAS A DEFECT WITH THE MESH. THE ISSUE IS THAT THERE IS NO RADIO-OPAQUE MARKER OR SIMILAR IN THE MESH THAT WOULD ALLOW FOR AN ALTERNATE MEANS OF LOCALIZATION IN THE EVENT THAT THE MESH IS MISPLACED. FOR EXAMPLE, WHEN WE WERE TRYING TO FIND THE MESH WE CONSIDERED USING A C ARM, BUT THERE IS NO WAY TO IDENTIFY THE MESH VIA X-RAY. I DON'T THINK THE MESH ITSELF CAUSED AN ISSUE, BUT IT WOULD BE POTENTIALLY HELPFUL TO BE ABLE TO FIND IT IF IT MIGRATES OR BECOMES DISPLACED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24966298 ↗
• InjuryFeb 19, 2026Patient-Device Incompatibility

  AS ALLEGED, THE PATIENT UNDERWENT A PROCEDURE IN MAY 2025 AND WAS IMPLANTED WITH A 3DMAX MID LEFT MESH. AS REPORTED SEVERAL MONTHS POST IMPLANT THE PATIENT EXPERIENCED A DELAYED INFECTION. THE WOUND IS BEING MANAGED WITH WOUND IRRIGATION AND THE PATIENT IS CURRENTLY HAVING "DISCOMFORT AT THE SURGICAL SITE, THAT SEEMS TO BE INFECTED" AND IS PLANNING TO INVESTIGATE AND CONSIDER TREATMENT OPTIONS.

  Patient problems: Discomfort; Wound Infection

  MAUDE report 24388803 ↗
• InjuryJan 5, 2026Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2025, PATIENT UNDERWENT TAPP REPAIR FOR A LEFT INGUINAL HERNIA AND WAS IMPLANTED WITH A 3DMAX MID MESH. IT WAS REPORTED THAT THE PATIENT SLOWLY DEVELOPED POSTOPERATIVE PAIN, TIGHTNESS AND REDNESS AT THE SURGICAL SITE. ABOUT TWO MONTHS LATER IMAGING REVEALED AN ABSCESS-LIKE LESION, AND ELEVATED WHITE BLOOD CELL COUNTS SUGGEST INFECTION. POSSIBILITY OF REOPERATION AND MESH REMOVAL. SUSPECTED MESH INFECTION. PATIENT HAD ADMINISTRATION OF ANTIBIOTICS.

  Patient problems: Abscess; Pain; Unspecified Infection

  MAUDE report 23959161 ↗
• InjurySep 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2025 THE PATIENT UNDERWENT A BILATERAL INGUINAL HERNIA REPAIR WITH IMPLANT OF TWO 3DMAX MID MESHES (LEFT DEVICE 1 AND RIGHT DEVICE 2). IT WAS REPORTED THAT POST IMPLANTATION THE PATIENT EXPERIENCED ALLERGIC REACTIONS, POST-OPERATIVE PAIN BEGAN ON (B)(6) 2025 AND HAS PERSISTED, INCLUDING BURNING SENSATIONS AT THE SURGICAL SITE, OCCASIONAL TESTICULAR PAIN, AND NERVE PAIN IN THE LEG. WHILE SOME SYMPTOMS HAVE IMPROVED, THE PATIENT CONTINUES TO EXPERIENCE DISCOMFORT, ESPECIALLY AT NIGHT. BILATERAL GROIN PAIN WAS ALSO REPORTED ON (B)(6) 2025. ADDENDUM: REACTIVITY TESTING HAS BEEN PERFORMED AND AS REPORTED THE RESULTS WERE NEGATIVE FOR AN ALLERGIC RESPONSE TO THE MESH SAMPLE. THIS FILE REPRESENTS DEVICE 1.

  Patient problems: Hypersensitivity/Allergic reaction; Neuralgia; Seroma

  MAUDE report 23124958 ↗
• MalfunctionAug 8, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A TAPP LAPAROSCOPIC SURGERY THE 3DMAX MID MESH WAS INSERTED USING A TROCAR, DURING INSERTION IT WAS NOTED THAT THE MESH WAS DAMAGED AND WAS REMOVED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748130 ↗
• MalfunctionJul 10, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING THE PROCEDURE, THE 3DMAX MID MESH WAS FOUND TO BE TORN UPON OPENING THE PACKAGE. REPORTEDLY, THE OUTER PACKAGING WAS INTACT WITH NO SIGNS OF DAMAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER MESH WITHOUT ANY COMPLICATIONS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22468129 ↗
• MalfunctionMay 7, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, WHILE OPENING THE STERILE PACKAGE OF 3DMAX MID SMALL DEBRIS LIKE BLACK DOTS WAS OBSERVED. IT WAS REPORTED THAT THE NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21977177 ↗
• MalfunctionMar 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN REMOVING THE 3DMAX MID MESH FROM THE PACKAGING IT WAS NOTED THAT THE PRODUCT WAS DEFORMED AS THERE WAS A BREAK IN THE EDGE SEAL. THE MESH WAS NOT USED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651507 ↗
• InjuryJan 14, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED ON (B)(6) 2024 THE PATIENT UNDERWENT A ROBOTIC LEFT INGUINAL HERNIA REPAIR WITH THE IMPLANT OF A 3DMAX MID MESH. POST IMPLANT THE PATIENT WAS CONCERNED REGARDING AN ALLERGIC REACTION TO THE MESH. THE ALLERGIST PERFORMED A REACTIVITY TEST ON (B)(6) 2024 WITH THE MESH AND CONFIRMED ON (B)(6) -2024 THE PATIENT HAD AN ALLERGIC REACTION. IT WAS REPORTED THAT THE PATIENT WANTS TO HAVE THE MESH REMOVED AND IS SCHEDULED TO MEET WITH HIS SURGEON.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21151465 ↗
• InjuryOct 30, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2024, THE PATIENT WAS IMPLANTED WITH TWO 3DMAX MID MESH (DEVICE #1 AND DEVICE #2). IT WAS REPORTED, POST IMPLANT PATIENT HAS BEEN IN AN "ALPHA-GAL FLARE UP SINCE THE SURGERY AND IS CONCERNED THERE ARE TRIGGERS IN THE MESH."

  Patient problems: Foreign Body Reaction

  MAUDE report 20566876 ↗
• MalfunctionMar 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A ROBOTIC INGUINAL HERNIA REPAIR, THE EDGES OF THE 3DMAX MID WERE NOTED BE CRACKED. AN 8MM TROCAR WAS USED FOR THE PROCEDURE. IT WAS REPORTED THAT THE SURGEON OPENED ANOTHER PIECE OF MESH TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. IN FOLLOW UP WITH THE SALES REP, WHO WAS NOT PRESENT IN THIS CASE, IT WAS STATED THE OR STAFF ARE ¿KIND OF ROUGH WITH HANDLING THE MESH WHEN REMOVING FROM THE PACKAGING AND INSERTING IT THROUGH THE TROCAR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18885724 ↗
• InjuryJan 25, 2024Defective Device; 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 BARD MESH (BARD FLAT MESH) ON (B)(6) 2022 AND/OR (B)(6) 2023. 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 SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Hernia; Insufficient Information; Scar Tissue

  MAUDE report 18578322 ↗
• 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 ALSO 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 17588749 ↗
• 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 17588730 ↗
• InjuryMay 9, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A ROBOTIC BILATERAL INGUINAL HERNIA REPAIR ON (B)(6) 2023, PATIENT WAS IMPLANTED WITH 3DMAX MID MESH RIGHT GROIN (DEVICE #1) AND 3DMAX MID MESH LEFT GROIN (DEVICE #2). IT WAS REPORTED THAT THE PATIENT DEVELOPED SYMPTOMS OF ITCHING AND RASH OF BILATERAL UE AND GROIN AND FACIAL SWELLING ON (B)(6) 2023. IT WAS ALSO REPORTED THAT PATIENT WAS PROVIDED WITH THE TREATMENT INCLUDING ANTIHISTAMINES, ORAL AND TOPICAL CORTICOSTEROIDS, ANTI-ITCH. THE PATIENT UNDERWENT REACTIVITY TESTING WITH MESH HOWEVER THE SURGEON REPORTS NOT HAVING ANY RESULTS AS OF AND IMMUNOLOGIST IS SUSPICIOUS OF A SINGLE DOSE OF CIPRO BEING THE INCITING AGENT. ADDENDUM: FINAL REACTIVITY TEST RESULTS SHOWED NO REACTION TO THE 3DMAX MID MESH.

  Patient problems: Itching Sensation; Rash; Swelling/ Edema

  MAUDE report 16894463 ↗
• MalfunctionMay 5, 2023Product Quality Problem; Product Quality Problem

  AS REPORTED, DURING A ROBOTIC INGUINAL HERNIA REPAIR, IT WAS FOUND THAT THE 3DMAX MID MESH WAS NOT WOVEN PROPERLY IN A CERTAIN SPOT CAUSING A KNOT. AS REPORTED, THE PROCEDURE WAS COMPLETED BY USING ANOTHER 3DMAX MID MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16876885 ↗
• MalfunctionMar 28, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR PROCEDURE, THE SURGEON INSERTED THE 3DMAX MID MESH THROUGH AN 8 MM TROCAR, AFTER DEPLOYING IT INTO THE PATIENT ABDOMEN, THE SURGEON OBSERVED THE MESH AS LOOKING "DRY ROTTED" (NOT NORMAL, EDGES APPEARED WRINKLED). THE SURGEON DECIDED NOT TO USE THE MESH AND WAS GIVEN A NEW 3DMAX MID MESH TO COMPLETE THE CASE. THERE WAS NO PATIENT HARM OR INJURY AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626352 ↗
• InjuryMay 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A ROBOTIC ASSISTED LEFT INGUINAL HERNIORRHAPHY PROCEDURE ON (B)(6)2021, THE PATIENT WAS IMPLANTED WITH BARD/DAVOL 3DMAX MID LG, LEFT. DURING THIS PROCEDURE THE PATIENT ALSO UNDERWENT A STITCH UMBILICAL HERNIORRHAPHY WITH CARTER THOMASON NEEDLE PASSER, 0 PROLENE. AS REPORTED, THE PATIENT UNDERWENT A ROBOTIC ASSISTED REPAIR OF RECURRENT LEFT INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 DURING WHICH A 3DMAX MID MESH WAS IMPLANTED.

  Patient problems: Hernia

  MAUDE report 14380469 ↗