3DMAX 0116312Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741200762), received between Nov 30, 2020 and Jun 10, 2026 — classified as 3 injuries, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 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 MARCH 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 PLACED

  Patient problems: Cyst(s); Hernia

  MAUDE report 25453147 ↗
• MalfunctionMay 19, 2026Unsealed Device Packaging

  AS REPORTED, THE INTERNAL PACKAGING OF A 3DMAX MID MESH WAS FOUND OPENED UPON OPENING THE OUTER BOX. THE MESH WAS NOT IMPLANTED AND AN ANOTHER PRODUCT WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25221225 ↗
• InjuryJun 9, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF BARD/DAVOL VENTRALEX ST ON (B)(6) 2021, MODIFIED ONFLEX ON (B)(6) 2023 AND 3DMAX MID ON (B)(6) 2024. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST ALL THE 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: Insufficient Information; Pain

  MAUDE report 22165628 ↗
• MalfunctionMar 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED, PATIENT UNDERWENT AN EMERGENCY BILATERAL INGUINAL HERNIA REPAIR SURGERY WITH THE IMPLANT OF TWO 3DMAX MID MESH (RIGHT AND LEFT) ON (B)(6) 2025. ABOUT A WEEK POST IMPLANT, PATIENT IS HAVING PAIN IN THE LEFT GROIN AND CONTACT REPORTS "THE MESH FEELS LIKE A PIECE OF SANDPAPER INSIDE OF HIM AND IT IS BURNING." PATIENT PRESENTED FOR POST-SURGERY FOLLOW UP IN (B)(6) 2025. THE SURGEON STATES NO PROBLEM WITH MESH AND OR PLACEMENT AND SUGGESTS NERVE DAMAGE OR IRRITATION OF PERITONEAL FLAP. A CT SCAN WAS ORDERED AND SHOWS MILD PERI COLONIC PERITONEAL THICKENING. PER CONTACT "THE PHYSICIAN DID NOT FEEL IT WAS RELATED TO THE HERNIA MESH AFTER I HAD THE CT SCAN" AND STATED "THERE'S NO BELIEF BY ME OR MD THAT THE UNFORESEEN PAIN WAS RELATED TO THE MESH - MORE RELATED TO THE INCISION/SUTURING OF THE FLAP." PATIENT WAS TREATED WITH MEDICATIONS (HYDROCODONE AND GABAPENTIN).

  Patient problems: Burning Sensation; Pain

  MAUDE report 21727313 ↗
• InjuryFeb 12, 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. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: Discomfort; Fatigue

  MAUDE report 21365098 ↗
• MalfunctionNov 30, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING A ROBOTIC INGUINAL CASE ON (B)(6) 2020, IT WAS IDENTIFIED THAT A BROWN FIBER WAS FOUND ON THE 3DMAX MID XL. THE ISSUE WAS NOTICED WHEN THE STERILE PACKAGING WAS OPENED PRIOR TO HANDING OFF TO THE OR NURSE IN THE STERILE FIELD. AS REPORTED, THE MESH WAS NOT USED, ANOTHER MESH WAS BROUGHT INTO THE CASE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10919424 ↗