3DMAX 0115322Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741030772), received between Oct 24, 2017 and Sep 30, 2026 — classified as 10 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Material Deformation

  Patient problems: Hematoma; Pain

  MAUDE report 50950935 ↗
• MalfunctionMay 13, 2026Device Markings/Labelling Problem

  AS REPORTED, DURING A BILATERAL INGUINAL SURGERY, THE SURGEON IDENTIFIED A SIZE MISMATCH IN ONE OF THE 3DMAX MESH PACKAGES. IT IS ALLEGED THAT A 3DMAX MESH (MEDIUM) WAS INSIDE PACKAGING LABELED AS 3DMAX MESH (EXTRA-LARGE). IT IS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH THE SAME 3DMAX MESH (MEDIUM). REPORTEDLY, THE PRODUCT PACKAGING WAS INTACT, SEALED, AND PROPERLY LABELED WITH THE PRODUCT DETAILS (LOT NO., CATALOG NO. AND EXPIRY DATE). THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25157121 ↗
• InjuryFeb 17, 2026Patient-Device Incompatibility

  AS ALLEGED (IN SUMMARY) BY PATIENT VIA ANSM REPORT (B)(4). ON (B)(6) 2021 DURING A RIGHT INGUINAL HERNIA REPAIR PROCEDURE THE PATIENT WAS IMPLANTED WITH A 3DMAX RIGHT MESH. SINCE THE DAY AFTER THE OPERATION - INCREASINGLY SEVERE PAIN ON EXERTION -TODAY HAS BECOME A CHRONIC PAIN. IT WAS AT THIS POINT THAT I BEGAN TO HAVE DOUBTS ABOUT THE SUPPOSED SUCCESS (ACCORDING TO THE SURGEON) OF THE OPERATION. THE POST-OPERATIVE PAIN WAS SUCH THAT I HAD TO EXTEND MY SICK LEAVE BY TWO WEEKS. BACK TO THE SAME PRACTITIONER FOR A FOLLOW-UP CONSULTATION, ALWAYS WITH THE SAME VERDICT: "IT'S NOTHING, EVERYTHING'S IN PLACE. WE DON'T UNDERSTAND". A FEW MONTHS WENT BY AND SO DID THE PAIN. ON THE OTHER HAND, ALL IT TAKES IS FOR ME TO CARRY A PARCEL THAT'S A BIT TOO BULKY, TO RUN A BIT TOO FAST, OR TO JUMP, A LITTLE TOO FAST, JUMP A LITTLE TOO HIGH, CLIMB A LADDER OR HOLD A HEDGE TRIMMER (I'M ALSO A GARDENER BY TRADE), AND THE TUGGING THE QUICKLY BECOMES UNBEARABLE. I'VE HAD TO HAVE AT LEAST 5 ULTRASOUNDS SINCE 2021, BECAUSE I WAS CONVINCED IT WAS RECURRING. THE PAIN DIDN'T BELONG TO ANYTHING VISIBLE. THE IMAGING STILL DIDN'T REVEAL ANYTHING ABNORMAL. HOWEVER, TODAY I CAN CLEARLY SEE SWELLING AND HARDENING

  Patient problems: Abdominal Pain; Swelling/ Edema

  MAUDE report 24365411 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING PLACEMENT OF THE 3DMAX MESH IT WAS NOTED THAT THE SEALED EDGE WAS BROKEN. ANOTHER MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038585 ↗
• MalfunctionFeb 8, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN INGUINAL HERNIA REPAIR, A 3DMAX MESH PACKAGING WAS OPENED AND IT WAS NOTICED THAT THE ENTIRE PIECE OF MESH WAS RIPPED. THE MESH WEAVE ITSELF APPEARED TO BE INCOMPLETE, LIKE THE "PRINTING" PATTERN OF THE MESH WAS NOT COMPLETED. IT WAS REPORTED THAT THE PACKAGING WAS INTACT, NO DAMAGE WAS NOTED TO THE OUTER OR STERILE PACKAGING. ANOTHER 3DMAX MESH WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18667023 ↗
• InjuryOct 20, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  AS REPORTED: THE PATIENT CAME TO THE HOSPITAL FOR TREATMENT DUE TO A RIGHT INGUINAL MASS. THE DOCTOR DIAGNOSED IT AS RIGHT INGUINAL DEFECT WITH INCARCERATION AND WAS ADMITTED TO THE HOSPITAL FOR TREATMENT. ON (B)(6) 2023 THE DOCTOR USED A DEFECT REPAIR PATCH TO PERFORM "RIGHT INGUINAL INCARCERATION RELIEF AND TENSION-FREE REPAIR UNDER GENERAL ANESTHESIA. ON (B)(6) 2023, PATIENT RETURNED TO THE WARD, AND THE WOUND TREATED. A SALT BAG WAS USED TO OCCUPY THE SPACE, AND HEMOSTASIS WAS TREATED SYMPTOMATICALLY. ON (B)(6) 2023, THE ATTENDING PHYSICIAN MADE A WARD ROUND AND FOUND THAT THE PATIENT COMPLAINED OF ABDOMINAL PAIN IN THE RIGHT SURGICAL AREA. A REVIEW OF POTASSIUM SUPPLEMENTATION REPORTED A CRITICAL VALUE. SYMPTOMATIC TREATMENT INCLUDING POTASSIUM SUPPLEMENTATION WAS CONTINUED, AND ANTI-INFECTION AND PAIN RELIEF AND OTHER SYMPTOMATIC TREATMENT AND CARRY OUT APPROPRIATE TREATMENT AND ACTIVITY OF THE LOWER LIMBS TO PREVENT DEEP VEIN THROMBOSIS. ON (B)(6) 2023, THE PATIENT'S GENERAL CONDITION WAS POOR, LETHARGIC, SLOW TO REFLECT LIGHT, IRREGULAR HEARTBEAT, BLOOD SUGAR 171/105MMHG. AFTER ACTIVE COMMUNICATION WITH THE PATIENT TRANSFERRED TO THE DEPARTMENT OF CRITICAL CARE MEDICINE FOR

  Patient problems: Abdominal Pain; Fluid Discharge; Impaired Healing

  MAUDE report 17981532 ↗
• InjuryDec 15, 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) 2015. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST 3DMAX MESH. 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 15985932 ↗
• MalfunctionJun 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL 3DMAX MESH (DEVICE #1) TORE UPON REMOVAL FROM THE PACKAGE. AS REPORTED, THE MESH WAS NOT USED AND ANOTHER BARD/DAVOL 3DMAX MESH (DEVICE #2) WAS OPENED, WHICH TORE AS WELL. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580379 ↗
• MalfunctionJun 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL 3DMAX MESH (DEVICE #1) TORE UPON REMOVAL FROM THE PACKAGE. AS REPORTED, THE MESH WAS NOT USED AND ANOTHER BARD/DAVOL 3DMAX MESH (DEVICE #2) WAS OPENED, WHICH TORE AS WELL. THE PROCEDURE WAS COMPLETED USING AN UNKNOWN MESH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580372 ↗
• MalfunctionFeb 24, 2022Expiration Date Error; Expiration Date Error

  THE CUSTOMER WAS PROVIDED WITH AN EXPIRED 3DMAX MESH ON (B)(6) 2022. THE MESH EXPIRATION DATE IS 28-DEC-2021. GENERAL SURGEON USED IT IN A PATIENT IN A PROCEDURE ON (B)(6) 2022. WHEN PROVIDED BY THE COURIER THE USER FACILITY DID NOT NOTICE THE EXPIRED DATE AS BEING PAST. ON THE DAY OF SURGERY THE OR TEAM DID NOT IDENTIFY THE PRODUCT EXPIRATION BEFORE USE. SURGEON PLANNED TO DISCUSS THE EVENT WITH THE PATIENT, AND THERE WAS NO REPORTED ACTION TAKEN. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13590205 ↗
• InjuryJan 3, 2022Defective Device; Patient Device Interaction Problem; Defective Device; Patient Device Interaction Problem

  ATTORNEY ALLEGES THAT THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF AN UNSPECIFIED BARD/DAVOL 3DMAX AND PERFIX PLUG ON (B)(6) 2007 AND/OR (B)(6) 2013. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH 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 13142543 ↗
• MalfunctionDec 17, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR/TEPP PROCEDURE ON (B)(6) 2021, WHEN THE BARD/DAVOL 3DMAX MESH (RIGHT X-LARGE) WAS INSERTED THROUGH A 10MM TROCAR, THE MESH TORE. THE SURGEON REMOVED THE MESH OUT OF THE TROCAR AND USED A NEW MESH TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13025271 ↗
• InjuryNov 24, 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 ON (B)(6) 2018 AND (B)(6) 2019. AS REPORTED, THE PATIENT IS MAKING A CLAIM FOR AN ADVERSE PATIENT OUTCOME AGAINST BOTH THE DEVICES. IT IS ALLEGED THAT THE PATIENT HAD SUBSEQUENT SURGICAL INTERVENTION DUE TO THE HERNIA MESH DEVICE. ATTORNEY ALLEGES THAT THE PATIENT EXPERIENCED EMOTIONAL DISTRESS AND THE DEVICE WAS DEFECTIVE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 12867078 ↗
• MalfunctionJun 3, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, DURING A ROBOTIC INGUINAL HERNIA REPAIR, ON (B)(6) 2021 AN EXTRA-LARGE BARD/DAVOL 3DMAX MESH TORE DURING INSERTION WHEN THE SURGEON ATTEMPTED TO INSERT THE MESH THROUGH AN 8 MM LAPAROSCOPIC PORT. A NEW PACKAGE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11934753 ↗
• MalfunctionJul 13, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, ON (B)(6) 2020, DURING THE IMPLANT OF A 3DMAX MESH THROUGH DAVINCI 8MM TROCAR, THE OUTSIDE OF MESH WAS RIPPED DUE TO GRABBING BY GRASPERS. THERE WAS NO PATIENT INJURY. THE PROCEDURE WAS COMPLETED WITH ANOTHER UNSPECIFIED MESH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10264434 ↗
• MalfunctionJul 8, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  AS REPORTED, ON (B)(6) 2020, DURING THE IMPLANT OF A 3DMAX MESH THROUGH DAVINCI 8MM TROCAR, THE OUTSIDE OF MESH WAS RIPPED DUE TO GRABBING BY GRASPERS. THERE WAS NO PATIENT INJURY. THE SAMPLE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10245877 ↗
• MalfunctionFeb 21, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SMALL PIECE OF FUZZ WAS NOTED IN THE STERILE PACKAGING. THE PRODUCT WAS NOT OPENED OR USED ON A PATIENT AS THE FUZZ INSIDE THE PACKAGING WAS NOTICED PRIOR TO OPENING THE PACKAGE.

  Patient problems: No Patient Involvement

  MAUDE report 9740954 ↗
• MalfunctionMay 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2019 A BARD/DAVOL 3DMAX MESH WAS BEING USED FOR A ROBOTIC INGUINAL HERNIA REPAIR. AS REPORTED THE MESH TORE DURING ATTEMPTED PLACEMENT. AS REPORTED THE TEAR WAS NEAR THE EDGE WHERE THE SURGEON WAS GRASPING THE MESH TO INSERT IT INTO THE ABDOMEN. THE CONTACT STATED, "I WANT TO SAY THAT IT WAS TORN IN MORE THAN ONE SPOT" AND THAT HE "WAS USING A DIFFERENT GRASPER THAN USUAL. IT WAS A SMALLER ONE BUT DON'T KNOW IF THAT WOULD HAVE MADE A DIFFERENCE." THE MESH WAS DISCARDED AND ANOTHER WAS BROUGHT IN TO COMPLETE THE CASE WITHOUT FURTHER ISSUE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8654473 ↗
• InjuryOct 16, 2018Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information; Defective Device; Patient-Device Incompatibility; Insufficient Device Problem Information

  THE FOLLOWING WAS INFORMATION WAS REPORTED BY THE PATIENT ATTORNEY. THE INFORMATION INCLUDED LIMITED PATIENT MEDICAL RECORDS: PER MEDICAL RECORDS: ON (B)(6) 2014 - THE PATIENT WAS DIAGNOSED WITH RIGHT INGUINAL HERNIA AND UNDERWENT A LAPAROSCOPIC REPAIR WITH IMPLANT OF A BARD/DAVOL 3DMAX MESH. PER THE IMPLANT OPERATIVE REPORT DETAILS, "PREPERITONEAL SPACE WAS OPENED WIDELY AND MASSIVE INDIRECT SAC WAS ENCOUNTERED. IT WAS CAREFULLY DISSECTED FREE AND REDUCED. THE 3DMAX MESH WAS PLACED ACROSS THE GROIN AND TACKED IN PLACE USING A NON BARD/DAVOL TACKING DEVICE." PER ATTORNEY FOR PATIENT: ON (B)(6) 2018 - THE PATIENT UNDERWENT A REVISION SURGERY WHICH INCLUDED EXPLANT OF THE BARD/DAVOL 3DMAX MESH.

  Patient problems: Hernia; Injury

  MAUDE report 7968627 ↗
• InjuryMar 14, 2018Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information; Defective Device; No Apparent Adverse Event; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY HAS ALLEGED; (B)(6) 2014 - THE PATIENT UNDERWENT SURGERY FOR IMPLANT OF TWO UNSPECIFIED 3DMAX MESH DEVICES; (DEVICE 1) AND (DEVICE 2). AS REPORTED, THE PATIENT'S ATTORNEY ALLEGES A GENERAL CLAIM "FOR PAST, PRESENT, AND FUTURE DAMAGES, INCLUDING BUT NOT LIMITED TO, MENTAL AND PHYSICAL PAIN AND SUFFERING FOR SEVERE AND PERMANENT PERSONAL INJURIES SUSTAINED".

  Patient problems: Disability; No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 7339536 ↗
• InjuryFeb 22, 2018Defective Device; Detachment of Device or Device Component; Patient Device Interaction Problem; Defective Device; Detachment of Device or Device Component; Patient Device Interaction Problem

  THE FOLLOWING WAS ALLEGED BY THE PATIENT'S ATTORNEY: (B)(6) 2003: THE PATIENT UNDERWENT SURGERY FOR REPAIR OF A RIGHT INGUINAL HERNIA. A BARD/DAVOL 3DMAX, REFERENCE NUMBER 0115322, LOT NUMBER 41FMDD04 WAS IMPLANTED TO REPAIR THE HERNIA DEFECT. (B)(6) 2014: THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE 3DMAX AFTER BEING ADMITTED TO THE HOSPITAL EXHIBITING SYMPTOMS INCLUDING NAUSEA, PERSISTENT VOMITING, ABDOMINAL PAIN, AND AN ABDOMINAL MASS. AS REPORTED, THE EXPLANTING SURGEON NOTED "LOTS OF ADHESIONS" AND ABSCESS FLUID AND THE 3DMAX WAS DESCRIBED AS "FLOATING INSIDE." AS ALLEGED, THE PATIENT WAS INJURED SEVERELY AND PERMANENTLY AND HAS SUFFERED AN WILL CONTINUE TO SUFFER PHYSICAL PAIN DUE TO THE ALLEGED DEFECTIVE 3DMAX.

  Patient problems: Abdominal Pain; Abscess; Adhesion(s); Disability; Inflammation; Unspecified Infection

  MAUDE report 7289989 ↗
• InjuryOct 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT IS REPORTED THAT ON (B)(6) 2011 THE PATIENT UNDERWENT THE REPAIR OF BILATERAL INGUINAL HERNIAS AND WAS IMPLANTED WITH TWO BARD 3DMAX MESH DEVICES. AS REPORTED FOR THE LAST YEAR AND A HALF THE PATIENT HAS BEEN EXPERIENCING INTERMITTENT BURNING, PULLING, TINGLING AND MILD PAIN / PINCHING SENSATIONS ON ONE OR BOTH SIDES. IT IS REPORTED THAT THESE SYMPTOM HAVE CONTINUED TO INCREASE IN INTENSITY AND DURATION.

  Patient problems: Burning Sensation; Pain; Tingling

  MAUDE report 6974377 ↗