3DMAX 0116321Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00801741200786), received between May 28, 2021 and May 8, 2026 — classified as 13 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (13 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Patient-Device Incompatibility

  AS REPORTED, THE PATIENT DEVELOPED A MESH INFECTION POST IMPLANT OF A 3DMAX MID MESH AND UNDERWENT REMOVAL OF MESH ON (B)(6) 2026.

  Patient problems: Unspecified Infection

  MAUDE report 25124742 ↗
• InjuryFeb 13, 2026Patient-Device Incompatibility

  AS REPORTED, DURING AN DIRECT INGUINAL HERNIA REPAIR A 3DMAX MID MESH WAS IMPLANTED ON 09-JAN-2025. POST IMPLANT THE PATIENT WAS DIAGNOSED WITH MEDIUM SIZED HERNIA RECURRENCE DURING PHYSICAL EXAMINATION AND SURGICAL INTERVENTION IS REQUIRED TO REPAIR THE HERNIA BUT HAS NOT BEEN SCHEDULED YET.

  Patient problems: Hernia

  MAUDE report 24331704 ↗
• MalfunctionFeb 12, 2026Material Split, Cut or Torn

  AS REPORTED, DURING A PROCEDURE USING 3DMAX MID MESH SURGEON FOLLOWED THEIR NORMAL ROUTINE IN WHICH THE MESH WAS STRETCHED PRIOR TO IMPLANTING TO MAKE SURE IT IS NOT DEFECTIVE AND THE MESH RIPPED. ANOTHER 3DMAX MID MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24326900 ↗
• InjuryFeb 3, 2026Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT A PROCEDURE WITH THE IMPLANT OF A 3DMAX MESH (DATE OF IMPLANT IS UNKNOWN). AS REPORTED SEVERAL MONTHS POST IMPLANT A DELAYED INFECTION WAS NOTED. THERE IS PUS DISCHARGE AND THE WOUND IS BEING TREATED BY CLEANING OF THE SSI SITE AND ANTIBIOTIC ADMINISTRATION.

  Patient problems: Purulent Discharge; Wound Infection

  MAUDE report 24245674 ↗
• InjuryDec 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2025, THE PATIENT UNDERWENT A TAPP PROCEDURE TO TREAT A RIGHT INGUINAL HERNIA USING A 3DMAX MID MESH. AT THREE WEEKS POST-OPERATION, THE PATIENT DEVELOPED PAIN AT THE SURGICAL SITE AND FEVER, REQUIRING READMISSION. MESH INFECTION WAS NOTED AND THE MESH WAS EXPLANTED ON (B)(6) 2025.

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 23820954 ↗
• InjurySep 30, 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. THIS FILE REPRESENTS DEVICE 2.

  Patient problems: Hypersensitivity/Allergic reaction; Neuralgia; Seroma

  MAUDE report 23181089 ↗
• MalfunctionAug 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR PROCEDURE, A CRACK WAS OBSERVED ON THE EDGE OF THE 3DMAX MID MESH. THE MESH WAS INSERTED INTO THE PATIENT BUT WAS SUBSEQUENTLY REMOVED DUE TO THE IDENTIFIED DEFECT. A 12MM TROCAR WAS USED DURING THE PROCEDURE. IT WAS REPORTED THAT ANOTHER 3DMAX MID MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22798129 ↗
• InjuryMar 11, 2025Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  PER LEGAL CLAIM: CASE # (B)(4). ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT INGUINAL HERNIA REPAIR SURGERY WITH 3DMAX MID MESHES (LEFT AND RIGHT) ON (B)(6) 2021. IT WAS ALLEGED THAT THE PATIENT HAD RECURRENT SIMPLE RIGHT INGUINAL HERNIA AND THEREBY UNDERWENT OPEN REPAIR WITH MESH ON (B)(6) 2023, DURING THE PROCEDURE THE SURGEON NOTED THAT THE "THE SPERMATIC CORD WAS A PIECE OF PREPERITONEAL FAT THAT WAS SNEAKING THROUGH THE INTERNAL INGUINAL RING. IT WAS GENTLY REDUCED INTO THE PREPERITONEAL SPACE". AS ALLEGED THE PATIENT EXPERIENCED HERNIA RECURRENCE, CHRONIC PAIN WHICH HAVE IMPAIRED DAILY ACTIVITIES. 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: Hernia; Pain

  MAUDE report 21571791 ↗
• MalfunctionOct 30, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A DA VINCI INGUINAL HERNIA REPAIR, WHILE OPENING THE 3DMAX MID RIGHT MESH IT WAS NOTED THAT THE BOTTOM PORTION OF THE MESH WAS CRACKED. IT WAS REPORTED THAT THE SURGEON DID NOT USE THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569260 ↗
• 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 20566889 ↗
• InjuryDec 11, 2023Defective 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 PERFIX PLUG ON (B)(6) 2015 AND/OR (B)(6) 2022. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE 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 18299196 ↗
• InjuryOct 21, 2023Defective Device; Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT WAS IMPLANTED WITH 3DMAX RIGHT MID LARGE MESH. IT IS ALLEGED THAT THE POST IMPLANTATION PATIENT HAD PAIN, SUFFERING, DISCOMFORT, DISABILITY, HOSPITALIZATION, MEDICAL AND NURSING TREATMENT. IT IS ALSO ALLEGED THAT THE PATIENT SUSTAINED PERSONAL INJURY, EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Discomfort; Pain

  MAUDE report 17981979 ↗
• MalfunctionOct 11, 2023Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR PROCEDURE, THE OR STAFF NOTICED A HOLE IN THE 3DMAX MID MESH. IT WAS REPORTED THAT 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 17911052 ↗
• MalfunctionSep 11, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING ROBOTIC INGUINAL HERNIA REPAIR, THE 3DMAX MID MESH EDGE WAS CRACKED AND TORN WHEN THE SURGEON FOLDED THE MESH USING A GRASPER. IT WAS REPORTED THAT THE MESH WAS NOT USED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719539 ↗
• 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 17588757 ↗
• 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 17588743 ↗
• 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 17588741 ↗
• 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 17588734 ↗
• 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 17588733 ↗
• 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 16894460 ↗
• InjuryMar 30, 2023Defective 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 MESH ON (B)(6)2022. 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; Insufficient Information; Nerve Damage

  MAUDE report 16641451 ↗
• MalfunctionOct 18, 2022Expiration Date Error; Expiration Date Error

  AS REPORTED, DURING A RIGHT INGUINAL HERNIA REPAIR ON (B)(6) 2022, PATIENT WAS IMPLANTED WITH 3DMAX MID MESH, WHICH HAD EXPIRED ON 28-AUG-2022. 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 15625321 ↗
• MalfunctionOct 18, 2022Off-Label Use; Off-Label Use

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR ON (B)(6) 2022, THE RIGHT-SIDED BARD / DAVOL 3DMAX MID MESH WAS MISTAKENLY IMPLANTED ON THE PATIENT'S LEFT SIDE WHICH WAS MARKED FOR A RIGHT-SIDE REPAIR. IT WAS REPORTED THAT THE SURGEON FLIPPED THE MESH OVER, SO THE MEDIAL MARKER WAS STILL POINTED MEDIALLY. AS REPORTED, THE SURGEON CHOSE TO LEAVE THE MESH IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624511 ↗
• InjuryMay 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A ROBOTIC ASSISTED BILATERAL INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A 3DMAX MID, RIGHT AND A 3DMAX MID, LEFT. AS REPORTED, DUE TO A HERNIA RECURRENCE THE PATIENT IS SCHEDULED TO HAVE A REVISION PROCEDURE ON (B)(6) 2022 ON THE RIGHT SIDE.

  Patient problems: Hernia

  MAUDE report 14380472 ↗
• InjuryMay 12, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, DURING A ROBOTIC ASSISTED BILATERAL INGUINAL HERNIORRHAPHY PROCEDURE ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH A 3DMAX MID LARGE, RIGHT AND 3DMAX MID MEDIUM, LEFT. ALSO PERFORMED WAS THE EXCISION OF A LIPOMA IN THE RIGHT GROIN AREA. AS REPORTED, ON (B)(6) 2022 THE PATIENT UNDERWENT A ROBOTIC ASSISTED EXPLORATION OF THE RIGHT INGUINAL AREA. IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REPAIR OF RECURRENT RIGHT INGUINAL HERNIA WITH IMPLANT OF A BARD FLAT MESH ON (B)(6) 2022.

  Patient problems: Hernia

  MAUDE report 14378139 ↗