SORBAFIX 0113115Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 00801741016691), received between Jul 16, 2018 and Jun 16, 2026 — classified as 3 injuries, 105 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (61 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE, AFTER DEPLOYING A FASTENER USING SORBAFIX ENHANCED DEVICE, THE OTHER FASTENERS ALONG WITH THE GUIDEWIRE DETACHED FROM THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522314 ↗
• MalfunctionJun 5, 2026Failure to Form Staple

  AS REPORTED, DURING PROCEDURE THREE (3) SORBAFIX ENHANCED FASTENERS FAILED TO FASTEN THE MESH TO THE TISSUE. REPORTEDLY, ANOTHER SORBAFIX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410439 ↗
• MalfunctionMay 29, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC IPOM PROCEDURE, THE SORBAFIX ENHANCED FASTENER DID NOT FIXATE PROPERLY AND THE FASTENER CAME OUT. REPORTEDLY, FEW OF THE FASTENERS GOT FIXATED AND THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25332837 ↗
• MalfunctionMay 18, 2026Failure to Form Staple

  AS REPORTED, DURING A RIGHT INGUINAL HERNIA REPAIR PROCEDURE, THE SORBAFIX ENHANCED DEVICE FAILED TO FIXATE AFTER DEPLOYING TWO (2) FASTENERS AS THE FASTENER'S KEPT "COMING OFF THE TISSUE". THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25205242 ↗
• MalfunctionMay 8, 2026Failure to Form Staple

  AS REPORTED, DURING AN IPOM PROCEDURE, WHILE TRYING TO FIXATE INTO THE ABDOMINAL SOFT TISSUE, THE SORBAFIX DEVICE FAILED TO FIXATE THE MESH. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY. REPORTEDLY, ADEQUATE AMOUNT OF PRESSURE WAS APPLIED WHILE USING THE SORBAFIX DEVICE. THE SURGEON DID NOT DRY FIRE TO CHECK IF THE ISSUE REOCCURRED. THE PROCEDURE WAS COMPLETED USING NEW FIXATION DEVICE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124902 ↗
• MalfunctionMar 25, 2026Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE THE SORBAFIX ENHANCED DEVICE WAS FAILED TO PENETRATE TISSUE, RESULTING IN DETACHMENT AND DIFFICULTY TO FIRE. REPORTEDLY, NONE OF THE FASTENERS GOT FIXATED. DURING THE DIAPHRAGMATIC REPAIR PROCEDURE, THE STAPLES WERE DISLODGED AND THEY WERE REMOVED FROM THE PATIENT BODY. THE PROCEDURE WAS COMPLETED BY HAND-SUTURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690265 ↗
• MalfunctionMar 19, 2026Failure to Form Staple

  AS REPORTED, DURING LAPAROSCOPIC TAPP PROCEDURE USING SORBAFIX ENHANCED FIXATION DEVICE THE TRIGGER PULL FELT LOOSE, AND FASTENERS DID NOT FIRE PROPERLY. REPORTEDLY, THE FASTENERS DID NOT PENETRATE THE TISSUE, AND THE LOOSE FASTENERS WERE REMOVED FROM PATIENT'S BODY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24638154 ↗
• MalfunctionMar 12, 2026Failure to Form Staple

  AS REPORTED PER ANVISA REPORT (IN SUMMARY): IT WAS REPORTED THAT, ACCORDING TO THE SURGEON, THE SORBAFIX ENHANCED FASTENERS DID NOT PROPERLY FIXATE AFTER APPLICATION DURING THE PROCEDURE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THAT THE PRODUCT WAS WITHIN ITS EXPIRATION DATE, WITH INTACT PACKAGING AND NO EVIDENCE OF IMPROPER STORAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582872 ↗
• MalfunctionJan 12, 2026Failure to Form Staple

  AS REPORTED, DURING THE PROCEDURE THE SURGEON ATTEMPTED TO FIXATE A MESH USING A SORBAFIX ENHANCED FIXATION DEVICE THE DEVICE WAS FIRED SEVERAL TIMES BUT FAILED TO MAKE THE NECESSARY SHOTS FOR STAPLING AND DID NOT SECURE THE MESH WITH THE FASTENERS. IT WAS REPORTED THAT NO LOOSE FASTENER PRESENTED AND THE FIXATION WAS APPLIED TO SOFT STRUCTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24041761 ↗
• MalfunctionDec 18, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING TAPP PROCEDURE USING SORBAFIX FIXATION DEVICE, TWO FASTENERS WERE DEPLOYED AT ONCE. IT WAS ALSO REPORTED THAT INITIAL THREE FASTENERS WERE FIXATED SUCCESSFULLY AND THE FIXATION WAS CARRIED OUT IN RECTUS ABDOMINIS MUSCLE, BILATERAL INFERIOR EPIGASTRIC ARTERY/VEIN, NEAR THE PUBIC BONE. THE FASTENER WAS REMOVED FROM THE PATIENT'S BODY AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838932 ↗
• MalfunctionAug 13, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC ABDOMINAL WALL HERNIA SURGERY, THE SORBAFIX ENHANCED FIXATION DEVICE FAILED TO FIXATE PROPERLY. IT WAS REPORTED THAT ONLY A FEW FASTENERS COULD BE FIXATED AND IT WAS VERY DIFFICULT TO FIXATE THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797159 ↗
• MalfunctionAug 13, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC ABDOMINAL WALL HERNIA REPAIR PROCEDURE ON (B)(6) 2025, A SORBAFIX ENHANCED FIXATION DEVICE WAS DEPLOYED INTO PERITONEUM AND FAILED TO FIXATE PROPERLY. IT WAS REPORTED THAT NO DRY FIRE WAS ATTEMPTED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE SURGEON IS WELL EXPERIENCED HANDLING THE DEVICE AND COUNTER PRESSURE WAS ADDED WHILE FIXATING THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797153 ↗
• MalfunctionAug 13, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC HIATAL HERNIA REPAIR PROCEDURE ON (B)(6) 2025, A SORBAFIX ENHANCED FIXATION DEVICE WAS DEPLOYED INTO PERITONEUM AND FAILED TO FIXATE PROPERLY. IT WAS REPORTED THAT NO DRY FIRE WAS ATTEMPTED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE SURGEON IS WELL EXPERIENCED HANDLING THE DEVICE AND COUNTER PRESSURE WAS ADDED WHILE FIXATING THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797149 ↗
• MalfunctionJul 25, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, THE SORBAFIX ENHANCED FIXATION DEVICE FASTENERS FAILED TO FIXATE TO THE WALL DURING MESH FIXATION. THE PROCEDURE WAS SUBSEQUENTLY COMPLETED USING AN ALTERNATIVE DEVICE. IT WAS ALSO REPORTED THAT APPROXIMATELY ONE OR TWO FASTENERS WERE SUCCESSFULLY DEPLOYED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22608067 ↗
• MalfunctionJul 25, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING MESH FIXATION, THE SORBAFIX FASTENER FELL INTO THE ABDOMINAL CAVITY AFTER A BLANK SHOT WAS FIRED WITH AN EMPTY FASTENER. THE LOOSE FASTENERS WERE REPORTED TO REMAIN IN THE ABDOMINAL CAVITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22608054 ↗
• MalfunctionJun 10, 2025Break; Break

  AS REPORTED DURING A TAPP PROCEDURE, WHILE TACKING THE MESH AND CLOSING UP THE PERITONEUM, THE SORBAFIX TACK WAS UNABLE TO FIXATE PROPERLY AND ONE OF THE TACKS END UP BEING BROKEN. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT. IT WAS REPORTED THAT THERE IS NO PHYSICAL SAMPLE AVAILABLE, ITEM WAS DISPOSED AS IT WAS USED IN PATIENT. THE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22176162 ↗
• MalfunctionApr 21, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING AN UNKNOWN PROCEDURE THE SORBAFIX ENHANCED DEVICE IS NOT FIRING CORRECTLY, AND THE FASTENERS WERE ONLY GOING IN PART WAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872659 ↗
• MalfunctionApr 11, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING A UNILATERAL INGUINAL HERNIOPLASTY PROCEDURE SORBAFIX ENHANCED FIXATION DEVICE WAS USED. IT WAS REPORTED THAT THE FASTENERS WERE STUCK TOGETHER AND DID NOT FIXATE THE MESH. THE PROCEDURE WAS COMPLETED USING ANOTHER NON-BD DEVICE AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826851 ↗
• MalfunctionApr 11, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE, A SORBAFIX ENHANCED FAILED DEVICE WAS USED. IT WAS REPORTED THAT THE FASTENERS FAILED TO FIXATE THE MESH. ANOTHER NON-BD DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21826836 ↗
• MalfunctionApr 2, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, A SORBAFIX ENHANCED DEVICE WAS USED. IT WAS REPORTED THAT THE DEVICE FIXATED FIRST FOUR FASTENERS SUCCESSFULLY AND DURING FIFTH FASTENER, IT DID NOT FIXATE. IT WAS REPORTED THAT THERE WAS NO LOOSE FASTENER PRESENT IN PATIENT'S BODY AND THE FASTENER WAS DEPLOYED AROUND THE COOPER¿S LIGAMENT WITH ADEQUATE COUNTER PRESSURE APPLIED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21752638 ↗
• MalfunctionFeb 24, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING TAPP PROCEDURE THE SURGEON TRIED TO FIXATE THE 3DMAX MESH USING SORBAFIX ENHANCED FIXATION DEVICE. IT WAS REPORTED THAT THE DEVICE WOULD NOT DEPLOY THE FIRST SHOT PROPERLY AND IT FELL INTO THE PATIENT'S BODY. THE LOOSE FASTENER WAS RECOVERED FROM PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21445781 ↗
• MalfunctionNov 15, 2024Break; Break

  AS REPORTED, DURING A PROCEDURE SORBAFIX ENHANCED FIXATION DEVICE WAS USED TO FIXATE THE MESH. IT WAS REPORTED THAT THE FASTENER HEAD WAS MISSING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695071 ↗
• MalfunctionNov 13, 2024Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING A TAPP PROCEDURE WHEN FIXATING THE MESH IN THE PREPERITONEAL SPACE, SORBAFIX ENHANCED DEVICES (DEVICE #1 AND DEVICE #2) DEPLOYED MORE THAN ONE FASTENER AT A TIME. IT WAS REPORTED THAT NO FASTENERS HAVE BEEN FIXATED FROM BOTH DEVICES AND ONE FASTENER WAS BROKEN (DEVICE #2). IT WAS ALSO REPORTED THAT THE DEPLOYED MULTIPLE FASTENERS AND BROKEN FASTENER WERE NOT REMOVED FROM THE PATIENT'S BODY. THE SURGEON HAS HIGH LEVEL OF EXPERIENCE, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER BRAND DEVICE. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675256 ↗
• MalfunctionNov 13, 2024Break; Unintended Ejection; Break; Unintended Ejection

  AS REPORTED, DURING A TAPP PROCEDURE WHEN FIXATING THE MESH IN THE PREPERITONEAL SPACE, SORBAFIX ENHANCED DEVICES (DEVICE #1 AND DEVICE #2) DEPLOYED MORE THAN ONE FASTENER AT A TIME. IT WAS REPORTED THAT NO FASTENERS HAVE BEEN FIXATED FROM BOTH DEVICES AND ONE FASTENER WAS BROKEN (DEVICE #2). IT WAS ALSO REPORTED THAT THE DEPLOYED MULTIPLE FASTENERS AND BROKEN FASTENER WERE NOT REMOVED FROM THE PATIENT'S BODY. THE SURGEON HAS HIGH LEVEL OF EXPERIENCE, AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER BRAND DEVICE. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE #2.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675227 ↗
• MalfunctionOct 8, 2024Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE THE SURGEON TRIED TO FIXATE THE 3DMAX LIGHT MESH USING SORBAFIX ENHANCED FIXATION DEVICE ON (B)(6) 2024. IT WAS REPORTED THAT THE FIXATION DEVICE DID NOT FIXATE THE MESH AT THE AREA OF COOPER LIGAMENT. IT WAS ALSO REPORTED THAT THERE WERE NO BROKEN FASTENERS, AND THE PROCEDURE WAS COMPLETED WITH SUCCESSFULLY FIXATED FASTENERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396859 ↗