OPTIFIX 0113330Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 00801741136566), received between Jan 22, 2020 and May 13, 2026 — classified as 2 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (32 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR ON (B)(6) 2026, THE SURGEON ATTEMPTED TO FIXATE THE MESH USING AN OPTIFIX AT FIXATION DEVICE; HOWEVER, DESPITE SEVERAL ATTEMPTS, THE FASTENERS FAILED TO PROPERLY SECURE THE MESH. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT AND ANOTHER FIXATION DEVICE TO COMPLETED THE PROCEDURE. THE SURGEON APPLIED COUNTER PRESSURE BUT WAS UNSUCCESSFUL IN FIXATING THE MESH. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162140 ↗
• MalfunctionMay 13, 2026Failure to Form Staple

  AS REPORTED, DURING A HERNIA REPAIR PROCEDURE, THE OPTIFIX AT FASTENERS FAILED TO FIXATE THE MESH. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162137 ↗
• MalfunctionApr 13, 2026Failure to Form Staple

  AS REPORTED, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR USING OPTIFIX AT FASTENERS DIDN'T PENETRATE THE TISSUE AND FAILED TO FIXATE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857754 ↗
• MalfunctionAug 12, 2025Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHEN FIRING THE OPTIFIX AT (DEVICE #1), THE FIRST FASTENER BROKE INTO PIECES. THE DOCTOR FIRED A COUPLE MORE TACKS OUTSIDE THE BODY TO CLEAR THE TACKER, BUT THEY ALL BROKE INTO PIECES. ANOTHER OPTIFIX AT (DEVICE #2), OF THE SAME LOT WAS OPENED. REPORTEDLY, SOME OF THE TACKS BROKE, BUT IT CLEARED OUT AND THEY WERE ABLE TO FINISH THE CASE WITH THIS DEVICE. AREA OF FIXATION WAS SOFT TISSUE ABOVE THE COOPER¿S LIGAMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784363 ↗
• MalfunctionAug 12, 2025Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHEN FIRING THE OPTIFIX AT (DEVICE #1), THE FIRST FASTENER BROKE INTO PIECES. THE DOCTOR FIRED A COUPLE MORE TACKS OUTSIDE THE BODY TO CLEAR THE TACKER, BUT THEY ALL BROKE INTO PIECES. ANOTHER OPTIFIX AT (DEVICE #2), OF THE SAME LOT WAS OPENED. REPORTEDLY, SOME OF THE TACKS BROKE, BUT IT CLEARED OUT AND THEY WERE ABLE TO FINISH THE CASE WITH THIS DEVICE. AREA OF FIXATION WAS SOFT TISSUE ABOVE THE COOPER¿S LIGAMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784345 ↗
• MalfunctionFeb 13, 2025Break; Break

  AS REPORTED, THE SURGEON EXPERIENCED BROKEN FASTENERS DEPLOYING WHILE THE OPTIFIX AT DEVICE. THE AREA OF FIXATION WAS BONE WITH COUNTER PRESSURE APPLIED, AND THE LOOSE FASTENERS WERE REMOVED. ANOTHER OPTIFIX WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21375395 ↗
• MalfunctionJan 22, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE, THE OPTIFIX AT FIXATION DEVICE WAS USED TO FIXATE THE MESH. IT WAS REPORTED THAT THE FASTENER DID NOT FIXATE THE MESH AND THERE WAS TOO MUCH CONCERN REGARDING A POTENTIAL PATIENT SAFETY ISSUE. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE # 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214444 ↗
• MalfunctionJan 22, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE, THE OPTIFIX AT FIXATION DEVICE WAS USED TO FIXATE THE MESH. IT WAS REPORTED THAT THE FASTENER DID NOT FIXATE THE MESH AND THERE WAS TOO MUCH CONCERN REGARDING A POTENTIAL PATIENT SAFETY ISSUE. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE # 3.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21214442 ↗
• MalfunctionJan 22, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE, THE OPTIFIX AT FIXATION DEVICE WAS USED TO FIXATE THE MESH. IT WAS REPORTED THAT THE FASTENER DID NOT FIXATE THE MESH AND THERE WAS TOO MUCH CONCERN REGARDING A POTENTIAL PATIENT SAFETY ISSUE. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21211600 ↗
• MalfunctionAug 12, 2024Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR ON (B)(6) 2024, THREE OPTIFIX AT DEVICES DEPLOYED BROKEN FASTENERS WHEN FIRED AND DIDN'T FIRE INTO THE MESH. THE BROKEN FASTENERS WERE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960268 ↗
• MalfunctionAug 12, 2024Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR ON (B)(6) 2024, THREE OPTIFIX AT DEVICES DEPLOYED BROKEN FASTENERS WHEN FIRED AND DIDN'T FIRE INTO THE MESH. THE BROKEN FASTENERS WERE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960266 ↗
• MalfunctionAug 12, 2024Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR ON (B)(6) 2024, THREE OPTIFIX AT DEVICES DEPLOYED BROKEN FASTENERS WHEN FIRED AND DIDN'T FIRE INTO THE MESH. THE BROKEN FASTENERS WERE REMOVED FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960263 ↗
• MalfunctionApr 10, 2024Failure to Form Staple; Failure to Form Staple

  AS REPORTED, THE SURGEON ATTEMPTED TO FIXATE SCAR TISSUE AND A DOUBLE LAYERED MESH USING AN OPTIFIX AT (DEVICE #1). AS REPORTED, THE FASTENERS WERE NOT FIXATING THE MESH. SURGEON WAS PROVIDED WITH ANOTHER OPTIFIX AT DEVICE (DEVICE #2 - SAME LOT) AND EXPERIENCED THE SAME ISSUE. SURGEON IS VERY EXPERIENCED ISSUING THE OPTIFIX AT DEVICE. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079873 ↗
• MalfunctionApr 10, 2024Failure to Form Staple; Failure to Form Staple

  AS REPORTED, THE SURGEON ATTEMPTED TO FIXATE SCAR TISSUE AND A DOUBLE LAYERED MESH USING AN OPTIFIX AT (DEVICE #1). AS REPORTED, THE FASTENERS WERE NOT FIXATING THE MESH. SURGEON WAS PROVIDED WITH ANOTHER OPTIFIX AT DEVICE (DEVICE #2 - SAME LOT) AND EXPERIENCED THE SAME ISSUE. SURGEON IS VERY EXPERIENCED ISSUING THE OPTIFIX AT DEVICE. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19079697 ↗
• MalfunctionJan 16, 2024Break; Failure to Form Staple; Break; Failure to Form Staple

  AS REPORTED, DURING AN INGUINAL HERNIA PROCEDURE, THE OPTIFIX AT FIXATION DEVICE DID NOT EXHIBIT FORCE TO RELEASE FASTENERS PROPERLY, CAUSING THE FASTENERS TO FALL OFF THE MESH/TISSUE WHEN ATTEMPTING TO FIXATE. IT WAS REPORTED THAT THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THAT WHEN ATTEMPTING TO DRY FIRE OUTSIDE OF THE PATIENT, THE DEVICE DEPLOYED BROKEN FASTENERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516714 ↗
• MalfunctionNov 10, 2023Failure to Form Staple; Failure to Form Staple

  AS REPORTED, OPTIFIX AT FIXATION DEVICE WAS USED TO FIXATE THE MESH. IT WAS REPORTED THAT TWO FASTENERS FIXATED THE MESH, AFTER WHICH THE DEVICE WOULD NOT FIXATE THROUGH THE REST OF THE MESH. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18113323 ↗
• MalfunctionJan 17, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, ON 22-DEC-2022 THE OPTIFIX AT FIXATION DEVICE WAS NOTED TO HAVE "PLASTIC STRINGS" COMING OUT OF THE FIXATION DEVICE HANDLE. AS REPORTED THE DEVICE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16186413 ↗
• MalfunctionSep 9, 2022Break; Break

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE SURGEON USED A BARD/DAVOL OPTIFIX AT FIXATION DEVICE. IT IS REPORTED THAT THE SURGEON ATTEMPTED TO USE THE ARTICULATING LEVER OF THE FIXATION DEVICE WITH EXCESSIVE FORCE. IT WAS REPORTED THAT THE SMALL PLASTIC PIECE THAT COVERS THE SCREW ON THE LEVER POPPED OFF AND FELL ONTO THE FLOOR. THE PIECE OF PLASTIC WAS RETRIEVED. A NEW OPTIFIX AT DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395270 ↗
• MalfunctionJun 1, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  AS REPORTED, UPON OPENING A CASE BOX OF BARD/DAVOL OPTIFIX AT ON (B)(6) 2022, ONE OF THE UNIT¿S EXTERIOR BOXES WAS NOTED DAMAGED AND THE INTERNAL STERILE PACKAGE WAS DAMAGED AS WELL. AS REPORTED, A SMALL PIN HOLE LIKE DAMAGE WAS NOTED IN THAT PACKAGING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14568467 ↗
• MalfunctionFeb 25, 2022Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING AN INCISIONAL VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE BARD/DAVOL OPTIFIX AT FIXATION DEVICE MISFIRED FASTENERS WHEN ATTEMPTING TO FIXATE A NON-BARD/DAVOL (STRATTICE) MESH. AS REPORTED, APPROXIMATELY 15 FASTENERS WERE DEPLOYED AND THERE WERE BOTH PROUD AND LOOSE FASTENERS, WHICH WERE REMOVED FROM THE OPERATIVE SITE. AS REPORTED, FIXATION WAS NOT APPLIED AT A HARD STRUCTURE AND THE DEVICE MISFIRED MORE IN THE ARTICULATED POSITION THAN IN THE STRAIGHT POSITION. AS REPORTED, A NON-BARD/DAVOL (PROTACK) DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13606651 ↗
• MalfunctionNov 17, 2021Defective Device; Defective Device

  AS REPORTED, ON (B)(6) 2021 DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR PROCEDURE, THE OPTIFIX AT FIXATION DEVICE WAS FOUND TO BE "DEFECTIVE." AS REPORTED, THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12827613 ↗
• MalfunctionSep 29, 2021Expiration Date Error; Expiration Date Error

  AS REPORTED DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, ON (B)(6) 2021, THE BARD/DAVOL OPTIFIX AT FIXATION DEVICE WAS USED. AS REPORTED IT WAS DISCOVERED AFTER IMPLANT THAT THE DEVICE HAD A LABELED EXPIRATION DATE OF 28-JUN-2021. IT WAS REPORTED THAT THE SURGEON DECIDED NOT TO REMOVE IT AFTER WEIGHING THE RISK/BENEFITS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12546185 ↗
• MalfunctionAug 5, 2021Component Misassembled; Component Misassembled

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021 A BARD/DAVOL OPTIFIX AT, 30 COUNT FIXATION DEVICE WAS USED. AFTER FIRING 7 STAPLES CORRECTLY, ONE OF THE FASTENERS CAME OUT BACKWARDS WHILE FIXATING THE MESH. THE REST OF THE FASTENERS FIRED WERE FINE. THE FASTENER REPORTED TO HAVE DEPLOYED BACKWARD WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12281504 ↗
• MalfunctionJul 27, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL OPTIFIX AT DEVICE WAS USED TO FIXATE AN UNKNOWN MESH. IT WAS REPORTED THAT THE TIP OF THE DEVICE SLIGHTLY CURVED WITHOUT THE SURGEON ARTICULATING IT, AND BROKEN FASTENERS WERE DEPLOYED. THE SURGEON REMOVED THE BROKEN FASTENER FROM THE PATIENT'S BODY; NONE OF THE FASTENERS USED FIXATED THE MESH. THE DEVICE WAS DRY FIRED OUTSIDE THE PATIENT'S BODY AND RELEASED BROKEN FASTENERS. AS REPORTED THE SURGEON WAS FIXATING AROUND COOPER'S LIGAMENT WHEN THE ISSUE PRESENTED. AS REPORTED, ANOTHER BARD/DAVOL OPTIFIX AT DEVICE WAS USED TO COMPLETE THE CASE WITHOUT ANY ISSUES. THE SURGEON IS AN EXPERIENCED USER OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12231567 ↗
• MalfunctionJul 23, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, A BARD/DAVOL OPTIFIX AT FIXATION DEVICE WAS USED TO FIXATE AN UNKNOWN MESH AROUND COOPER'S LIGAMENT. AS REPORTED, THE FASTENERS DEPLOYED BROKEN AND WERE REMOVED FROM THE PATIENT'S BODY. THE DEVICE WAS DRY FIRED OUTSIDE THE PATIENT'S BODY AND RELEASED BROKEN FASTENERS ALSO NOTED WAS THAT THE TIP OF THE DEVICE WAS SLIGHTLY CURVED. AS REPORTED, ANOTHER BARD/DAVOL OPTIFIX AT DEVICE WAS USED TO COMPLETE THE CASE WITHOUT ANY ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12219574 ↗