PERMAFIX 0113120Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741016721), received between Jan 11, 2018 and Jan 29, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2026Failure to Form Staple

  AS REPORTED, DURING AN INCISIONAL HERNIA REPAIR WITHOUT OBSTRUCTION, THE PERMAFIX ENHANCED FIXATION DEVICE FASTENERS FAILED TO FIXATE. IT WAS REPORTED THAT ONLY A PARTIAL TACK WAS DEPLOYED IN THE AREA OF FIXATION, WHICH INVOLVED SOFT TISSUE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING AN ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209110 ↗
• MalfunctionDec 17, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING AN ABDOMINAL WALL HERNIA SURGERY (LAPAROSCOPIC IPOM), THE PERMAFIX ENHANCED FIXATION DEVICE FASTENERS FAILED TO FIXATE AND DISLODGED FREQUENTLY. THE SURGEON WAS EXPERIENCED USING PERMAFIX AND REMOVED THE LOOSE FASTENERS FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831728 ↗
• MalfunctionApr 16, 2024Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING AN INCISIONAL HERNIA REPAIR PROCEDURE, THE SURGEON FELT IT WAS HARD TO PULL THE TRIGGER WHILE TRYING TO FIXATE THE MESH USING A PERMAFIX ENHANCED FIXATION DEVICE. IT WAS ALSO REPORTED THAT THE DEVICE FAILED TO FIXATE THE MESH AND THE PROCEDURE WAS COMPLETED USING ANOTHER FIXATION DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115576 ↗
• MalfunctionSep 13, 2022Mechanical Problem; Failure to Form Staple; Mechanical Problem; Failure to Form Staple

  AS REPORTED, DURING A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH AN UNKNOWN MESH FIXATED USING A BARD/DAVOL PERMAFIX FIXATION DEVICE. AS REPORTED, COUNTER PRESSURE WAS APPLIED ON THE TARGET AREA WHILE FIXATING THE IMPLANT INTO THE TISSUE AND THE HANDLE (TRIGGER) WAS ABLE TO BE PULLED COMPLETELY. IT WAS REPORTED THAT THE FASTENER HAS NO FIRING FORCE AND THE MESH CANNOT BE FIXATED INTO THE TISSUE. IT WAS REPORTED THAT FASTENERS WERE LOOSE AND REMOVED FROM THE PATIENT BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410353 ↗
• MalfunctionDec 6, 2021Break; Failure to Fire; Break; Failure to Fire

  AS REPORTED, DURING UNKNOWN PROCEDURE ON (B)(6) 2021, THE BARD/DAVOL PERMAFIX FIXATION DEVICE DEPLOYED HALF A PIECE OF FASTENER (BROKEN FASTENER) EACH TIME. THERE WAS NO REPORTED PATIENT INJURY. ADDENDUM PER ADDITIONAL INFORMATION: AS REPORTED, DURING A GENERAL SURGERY PROCEDURE, THE SURGEON ATTEMPTED TO DEPLOY THE FIRST FASTENER OF THE PERMAFIX DEVICE BY PULLING THE HANDLE AND NO FASTENER WAS RELEASED FROM THE DEVICE. AS REPORTED, THE DEVICE WAS NOT USED ON THE PATIENT. IT WAS REPORTED THAT ANOTHER PERMAFIX FIXATION DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12935560 ↗
• MalfunctionSep 10, 2019Detachment of Device or Device Component; Device Misassembled During Manufacturing /Shipping; Detachment of Device or Device Component; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT DURING A PROCEDURE, A SCREW IN THE HANDLE OF THE PERMAFIX FIXATION PRODUCT CAME LOOSE. THE SCREW WAS RETRIEVED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8981772 ↗
• MalfunctionMay 6, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PERMAFIX FIXATION DEVICE WAS UNPACKED IN THE MIDDLE OF PROCEDURE AND IT WAS FOUND THAT IT WAS CONTAMINATED BY WHAT WAS DESCRIBED AS A BLOODSTAIN INSIDE THE PACKAGE. PROBLEM WAS NOTED OUT OF BOX AND THE PRODUCT WAS NOT USED IN THE CASE. THE IMAGE PROVIDED BY THE USER FACILITY SHOWS A STAIN ON THE INNER SIDE OF THE STERILE POUCH. THE ORIGIN OF THE STAIN CANNOT BE DETERMINED AT THIS TIME.

  Patient problems: No Patient Involvement

  MAUDE report 8582180 ↗
• MalfunctionApr 24, 2019Use of Device Problem; Expiration Date Error; Use of Device Problem; Expiration Date Error

  IT WAS REPORTED THAT AN EXPIRED PERMAFIX FIXATION DEVICE WAS ACCIDENTALLY USED DURING A PROCEDURE AND THIS WAS NOT REALIZED UNTIL AFTER THE SURGERY. THE CUSTOMER WAS LOOKING FOR ADVICE ON THE EXPIRATION DATE AS TO WHETHER IT PERTAINED TO THE STERILITY OR PRODUCT INTEGRITY. THE USER FACILITY WAS PLANNING TO SPEAK WITH THE PATIENT AND THEIR OWN MANAGEMENT AND LEGAL TEAM. NO ADVERSE OUTCOMES WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8545971 ↗
• InjuryJan 11, 2018Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Synchronization; Incorrect, Inadequate or Imprecise Result or Readings; Inaccurate Synchronization

  IT WAS REPORTED THAT DURING A VENTRAL INCISIONAL HERNIA REPAIR WITH A PERMAFIX FIXATION DEVICE WAS USED. AFTER THE SIXTH FASTENER WAS DEPLOYED, NO ADDITIONAL FASTENERS WOULD FIXATE TO THE ABDOMINAL WALL. THE REMAINING FASTENERS WERE DEPLOYED WITHOUT SUCCESS. IT WAS REPORTED THAT THE SURGEON INITIALLY PLACED THREE TROCARS AND LATER PLACED TWO ADDITIONAL TROCARS TO GET BETTER ANGLE OF INSERTION. IT IS NOT KNOWN AT THIS TIME IF THE SURGICAL INTERVENTION OF PLACING ADDITIONAL TROCARS WAS DUE TO THE REPORTED DEVICE ISSUE, OR WAS DONE TO FACILITATE FIXATION IN GENERAL. AS REPORTED A NON BARD/DAVOL FIXATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY, BEYOND THE PLACEMENT OF ADDITIONAL TROCARS. THE SURGEON REPORTEDLY IS A NEW USER OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7184304 ↗