3DMAX 0117320Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00801741031052), received between Dec 5, 2018 and Jun 11, 2026 — classified as 12 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Unsealed Device Packaging

  AS REPORTED, ON (B)(6) 2026 DURING A PROCEDURE WHEN THE 3DMAX LIGHT PACKAGE WAS OPENED THE MESH FELL OUT DUE TO A DEFECT IN THE INNER SEAL OF THE MESH PACKAGING. REPORTEDLY, ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT WITH THE MESH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25473280 ↗
• InjuryMar 30, 2026Patient-Device Incompatibility

  AS REPORTED, THE PATIENT HAD RECURRENT INGUINAL HERNIA POST IMPLANT OF 3DMAX LIGHT MESH.

  Patient problems: Hernia

  MAUDE report 24716739 ↗
• MalfunctionOct 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A PROCEDURE, AFTER REMOVING THE 3DMAX LIGHT MESH FROM THE PACKAGING IT WAS NOTED THAT THE EDGE OF THE MESH WAS TORN. THE MESH WAS NOT USED, AND ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE INNER PACKAGING WAS INTACT WITHOUT ANY DAMAGES. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23220858 ↗
• MalfunctionAug 20, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR (TAPP) PROCEDURE THE EDGE OF 3DMAX LIGHT MESH WAS FOUND TO BE CRACKED. IT WAS REPORTED THAT 12MM TROCAR WAS USED FOR THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22850597 ↗
• InjuryJun 13, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PER INFORMATION PROVIDED: (B)(6) 2012 ¿ PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND RIGHT INGUINAL HERNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF TWO PERFIX PLUG (DEVICE #1, #2). PER OP NOTES, ¿THERE WAS A LARGE DIRECT DEFECT. TWO EXTRA-LARGE PERFIX PLUGS (DEVICE #1, #2) WERE PLACED IN THE DEFECT AND PATCH WAS TACKED TO THE PUBIC TUBERCLE MEDIALLY, INFERIORLY TO SHELVING EDGE OF INGUINAL LIGAMENT AND SUPERIORLY TO CONJOINED TENDON USING SUTURES. THE UMBILICAL HERNIA WAS REPAIRED USING SUTURES.¿ (B)(6) 2016 ¿ PATIENT WAS DIAGNOSED WITH RIGHT RECURRENT INDIRECT INGUINAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF 3DMAX LIGHT MESH (DEVICE #3). PER OP NOTES, ¿SOME MESH PLUGS (DEVICE #1, #2) WERE ADHERENT. THE HERNIA WAS LATERAL SO THERE WAS AN INDIRECT INGUINAL HERNIA. THEN, A 3DMAX LIGHT MESH (DEVICE #3) WAS TACKED ON EITHER SIDE OF EPIGASTRIC AS WELL AS MEDIALLY TO THE COOPER¿S LIGAMENT.¿ (B)(6) 2019 ¿ PATIENT WAS DIAGNOSED WITH RIGHT LOWER QUADRANT ABDOMINAL PAIN THEREBY UNDERWENT LAPAROSCOPIC LYSIS OF ADHESIONS. PER OP NOTES, ¿IN THE RIGHT GROIN, ADHESIONS OF THE RIGHT COLON AND CECUM TO THE PREVIOUSLY PLACED PREPERITONEAL MESH (DEVICE #3), AND MEDIAL

  Patient problems: Abdominal Pain; Adhesion(s)

  MAUDE report 22201872 ↗
• InjuryJan 3, 2025Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  PER INFORMATION PROVIDED BY PATIENT'S ATTORNEY: (B)(6) 2013 - PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND INGUINODYNIA THEREBY UNDERWENT OPEN REPAIR WITH THE IMPLANT OF PERFIX PLUG ONLAY PATCH (DEVICE #1). PER OPERATIVE NOTES, "A LONG LARGE TUBULAR PORTION OF LIPOMA OF A CORD TRAPPED IN TISSUE WAS DISSECTED. THE SCARS WERE LYSED. THE PERFIX PLUG ONLAY PATCH WAS ONLY USED AND SECURED APICALLY TO THE LACUNAR LIGAMENT AND SUTURED." (NOTE: THE PLUG PORTION OF PERFIX PLUG WAS NOT IMPLANTED DURING THE PROCEDURE). (B)(6) 2015 - PATIENT WAS DIAGNOSED WITH RECURRENT RIGHT INGUINAL HERNIA AND RIGHT GROIN PAIN THEREBY UNDERWENT OPEN REPAIR WITH THE EXPLANT OF PERFIX PLUG ONLAY PATCH (DEVICE #1) AND IMPLANT OF 3DMAX LIGHT MESH (DEVICE #2). PER OPERATIVE NOTES, "THE EXTERNAL OBLIQUE FASCIA WAS ADHERENT TO THE PREVIOUSLY PLACED MESH AND WAS DISSECTED OFF. THE MESH WAS DISSECTED FROM THE INGUINAL FLOOR. THE SMALL FAT CONTAINING HERNIA WAS CLOSED WITH SUTURE AND THE INGUINAL FLOOR WAS REPAIRED. A 3DMAX LIGHT MESH (DEVICE #2) WAS PLACED IN THE INGUINAL FLOOR AND TACKED." (B)(6) 2016 - PATIENT WAS DIAGNOSED WITH BILATERAL DIRECT INGUINAL HERNIA THEREBY UNDERWENT ROBOTIC ASSISTED LAPAROSCOPI

  Patient problems: Hernia

  MAUDE report 21064579 ↗
• MalfunctionMar 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, WHEN THE NURSE OPENED THE STERILE PACKING OF THE 3DMAX LIGHT MESH FOR INSTALLATION, THEY NOTICED THAT THE EDGE OF THE MESH WAS BROKEN AND WAS NOT USED. IT WAS REPORTED THAT THE BOX WAS COMPLETELY SEALED AND THERE WAS NO DAMAGE NOTED ON INNER OR OUTER PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18958284 ↗
• MalfunctionDec 19, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A TAPP PROCEDURE ON (B)(6) 2022, USING A 3DMAX LIGHT MESH, THE SURGEON ROLLED THE MESH PRIOR TO INSERTION, AND IT WAS NOTED THAT THE EDGE OF THE MESH WAS TORN. IT WAS REPORTED THAT THE MESH WAS REMOVED FROM THE PATIENT'S BODY 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 16004550 ↗
• MalfunctionNov 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED ON (B)(6) 2022 PRIOR TO OPENING THE 3DMAX LIGHT MESH CLAM SHELL TRAY A FOREIGN MATERIAL (HAIR LIKE), WAS NOTED IN THE STERILE PRODUCT PACKAGING. ANOTHER DEVICE WAS USED TO COMPLETE THE LAPAROSCOPIC INGUINAL HERNIA REPAIR (TAPP) PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835408 ↗
• MalfunctionOct 28, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, WHILE POSITIONING TO FIXATE THE BARD/DAVOL 3DMAX LIGHT MESH USING GRASPERS, MESH RIPPED INTO TWO PIECES. IT WAS REPORTED THAT THE MESH WAS REMOVED FROM PATIENT'S BODY AND ANOTHER 3DMAX LIGHT MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15690033 ↗
• MalfunctionJul 19, 2022Material Separation; Material Separation

  AS REPORTED, DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL 3DMAX LIGHT MESH WAS SEPARATED FROM THE EDGE SEAL AFTER THE MESH WAS IMPLANTED IN THE ABDOMINAL CAVITY AND WAS IMMEDIATELY REMOVED FROM THE PATIENT¿S BODY. IT WAS ALSO REPORTED THAT ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15053191 ↗
• InjuryMay 26, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF UNSPECIFIED BARD/DAVOL 3DMAX LIGHT (X2) ON (B)(6) 2016 (X2). 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: Hernia; Insufficient Information; Pain

  MAUDE report 14507713 ↗
• MalfunctionAug 27, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, WHEN OPENING THE PACKAGE OF THE BARD/DAVOL 3DMAX LIGHT MESH ON (B)(6) 2021, IT WAS NOTED THAT THE EDGE SEAL PART OF THE MESH WAS DAMAGED. THE MESH WAS NOT USED ON THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377714 ↗
• MalfunctionJan 29, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, WHEN THE SURGEON INSERTED THE BARD/DAVOL 3DMAX LIGHT MESH DOWN THE PORT, A SMALL PART OF THE EDGE OF THE MESH WAS TORN. THE SURGEON REMOVED THE MESH AND COMPLETED THE PROCEDURE USING ANOTHER BARD/DAVOL 3DMAX MESH AND THERE WAS A DELAY OF 2-3 MINUTES. AS REPORTED, THE SURGEON WAS NOT SURE IF THE INSTRUMENT USED CAUSED IT OR SOMETHING IN THE PORT, BUT FROM THE SURGEON'S PERSPECTIVE SIGNIFICANT FORCE WAS NOT APPLIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11251668 ↗
• MalfunctionDec 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2020, THE 3DMAX LIGHT MEDIUM RIGHT MESH WAS OPENED PRIOR TO THE PROCEDURE AND NOTED THAT THE MESH WAS FOLDED AND DAMAGED. THE ALLEGED DAMAGE WAS SEEN AROUND THE CENTER OF THE MESH. THE EDGE WAS DAMAGED BY THE USER WHEN THE MESH WAS GRASPED BY FORCEPS. THE PROCEDURE WAS COMPLETED BY USING ANOTHER MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11097627 ↗
• MalfunctionOct 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, WHILE OPENING THE PACKAGE OF A 3DMAX LIGHT MEDIUM RIGHT MESH, IT WAS FOUND THAT THE SEALED PART ON THE OUTSIDE OF THE MESH WAS FOLDED OR DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765663 ↗
• MalfunctionOct 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2020, WHILE OPENING THE PACKAGE OF A 3DMAX LIGHT MEDIUM RIGHT MESH, IT WAS FOUND THAT THE SEALED PART ON THE OUTSIDE OF THE MESH WAS FOLDED OR DAMAGED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10765427 ↗
• MalfunctionJul 22, 2020Difficult or Delayed Positioning; Material Split, Cut or Torn; Difficult or Delayed Positioning; Material Split, Cut or Torn

  AS REPORTED, DURING LAPAROSCOPIC PLACEMENT PROCEDURE OF 3DMAX LIGHT MESH ON (B)(6) 2020, IT WAS NOTICED THAT THE MESH WAS ALREADY CRACKED. HOWEVER, THE MESH WAS INSERTED THROUGH THE TROCAR WITH THE INNER DIAMETER OF 12MM WHILE IT WAS DIFFICULT TO DEPLOY DOWN THE TROCAR AND THEREFORE THE MESH WAS REMOVED. THE SURGEON USED UNKNOWN MESH TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10307594 ↗
• InjuryJul 7, 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 UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH AND PERFIX PLUG. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH WHICH WAS IMPLANTED ON (B)(6) 2016. 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; Injury; Nerve Damage

  MAUDE report 10243133 ↗
• InjuryApr 2, 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 ON (B)(6) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT. 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: Disability; Injury; Pain

  MAUDE report 9917874 ↗
• MalfunctionFeb 21, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A TEAR WAS NOTED ON THE TOP OF THE 3DMAX MESH WHEN OPENING THE PACKAGE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO REMOVING THE MESH. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9742210 ↗
• InjuryJan 8, 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 TWO UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESHES AND VENTRALEX HERNIA PATCH. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 3DMAX LIGHT MESHES WHICH WERE IMPLANTED ON (B)(6) 2017. 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; Injury; Pain

  MAUDE report 9563352 ↗
• InjuryDec 4, 2019Patient-Device Incompatibility; Defective Device; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3D MAX AND AN UNSPECIFIED BARD/DAVOL 3D MAX LIGHT ON (B)(6) 2018. IT IS ALLEGED THE PATIENT HAD UNSPECIFIED INJURIES ON (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. 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." ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Emotional Changes; Injury; Pain; Scar Tissue

  MAUDE report 9412798 ↗
• InjuryNov 27, 2019Defective Device; Insufficient Device Problem Information; Migration; Defective Device; Insufficient Device Problem Information; Migration

  ATTORNEY ALLEGES THAT ON (B)(6) 2016, THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX LIGHT MESH (DEVICE #1) AND AN UNSPECIFIED BARD/DAVOL PERFIX PLUG. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. AS REPORTED, THE PATIENT IS ONLY MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST THE 3DMAX LIGHT MESH (DEVICE #1). AS REPORTED, THE ATTORNEY ALLEGES PRODUCT IS DEFECTIVE AND THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS.

  Patient problems: Hernia; Injury

  MAUDE report 9384403 ↗
• MalfunctionSep 19, 2019Material Puncture/Hole; Device Damaged by Another Device; Material Split, Cut or Torn; Material Puncture/Hole; Device Damaged by Another Device; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) "019" A BARD 3DMAX LIGHT MESH WAS BEING USED FOR A LAPAROSCOPIC HERNIA REPAIR. AS REPORTED PRIOR TO IMPLANT THE MESH WAS FOUND TO HAVE A HOLE. THERE WAS NO INJURY TO THE PATIENT OR INTERVENTION. AS REPORTED, THE PACKAGING WAS INSPECTED AND REPORTED TO BE INTACT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9087928 ↗