3DMAX 0117312Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741031045), received between May 30, 2019 and Mar 12, 2026 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2026Patient-Device Incompatibility

  AS REPORTED, ON (B)(6) 2025 THE PATIENT UNDERWENT BILATERAL INGUINAL HERNIA REPAIR AND WAS IMPLANTED WITH 3DMAX LIGHT MESH. ONE YEAR POST IMPLANTATION THE PATIENT HAD AN ASYMPTOMATIC LEFT INGUINAL HERNIA RECURRENCE. THERE WAS NO HERNIA RECURRENCE WITH THE RIGHT SIDED REPAIR. AS REPORTED THE PATIENT HAS NO HISTORY OR RISK FACTORS THAT COULD EXPLAIN THE RECURRENCE AND THE DOCTOR HAS REQUESTED A CT SCAN.

  Patient problems: Hernia

  MAUDE report 24583336 ↗
• MalfunctionFeb 27, 2026Material Split, Cut or Torn

  AS REPORTED, AN UNILATERAL INGUINAL HERNIA REPAIR WAS PERFORMED LAPAROSCOPICALLY USING 3DMAX LIGHT MESH ON (B)(6) 2026. DURING THIS PROCEDURE, A CUT IN THE 3DMAX LIGHT MESH WAS NOTED WHILE PLACING IT IN THE INGUINAL ANATOMY. IT WAS REPORTED THAT THIS CUT IN THE MESH MADE IT MORE DIFFICULT TO POSITION THE MESH, AS THE SURGEON HAD TO SUTURE DEFECT TO CLOSE IT, WHICH INCREASED THE DURATION OF THE SURGERY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470791 ↗
• InjuryDec 18, 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 MESH ON (B)(6) 2021. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 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

  MAUDE report 16001551 ↗
• InjurySep 2, 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, 3DMAX LIGHT MESH AND PERFIX PLUG ON (B)(6) 2015 AND/OR (B)(6) 2016. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL 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, SUSTAINED PERSONAL INJURY AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12416204 ↗
• InjuryFeb 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 AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH ON (B)(6) 2018. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH. ATTORNEY ALLEGES THAT THE PATIENT SUSTAINED PERSONAL INJURY. IT IS ALSO ALLEGED THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 9710940 ↗
• InjuryOct 28, 2019Defective 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 LIGHT MESH (DEVICE #1) OR AN UNSPECIFIED BARD/DAVOL PERFIX PLUG (DEVICE #2) ON (B)(6) 2018. 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 (DEVICE #1) AND THE PERFIX PLUG (DEVICE #2). AS REPORTED, THE ATTORNEY ALLEGES PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Injury; Pain

  MAUDE report 9246921 ↗
• InjuryMay 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT ON (B)(6) 2019 THE PATIENT UNDERWENT LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR AND WAS IMPLANTED WITH ONE LEFT 3DMAX LIGHT MESH (DEVICE 1) AND ONE RIGHT 3DMAX LIGHT MESH (DEVICE 2). AS REPORTED APPROXIMATELY ONE MONTH POSTOPERATIVE THE PATIENT PRESENTED WITH PAIN ON THE LEFT AND RIGHT SIDE. AS REPORTED ON (B)(6) 2019 CULTURES WHERE TAKEN OF THE LEFT AND RIGHT HERNIA SAC WITH A POSITIVE FOR BACTERIA (PEPTONOPHILUS HAREL) GROWTH ON THE LEFT SIDE. ON (B)(6) 2019 THE PATIENT UNDERWENT AN OPEN SURGICAL PROCEDURE WITH REMOVAL OF THE HERNIA SACS AND BOTH OF THE 3DMAX LIGHT MESH (DEVICE 1 AND 2). THERE WAS POSITIVE BACTERIOLOGY ON BOTH HERNIA SACS. THE EXPLANTED SAMPLES WERE DISCARDED BY THE USER FACILITY. FOLLOWING EXPLANT THE PATIENT WAS MONITORED AND TREATED WITH ANTIBIOTIC FOR ONE MONTH.

  Patient problems: Bacterial Infection; Pain; Unspecified Infection

  MAUDE report 8653976 ↗