SORBAFIX 0113116Recalls & reported problems

Summary

The FDA's MAUDE database contains 162 adverse event reports that list this exact device (DI 00801741016707), received between Jul 28, 2017 and Sep 3, 2026 — classified as 7 injuries, 155 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (109 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 162 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50592987 ↗
• MalfunctionAug 25, 2026Failure to Form Staple

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50439070 ↗
• MalfunctionJun 5, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE, THE SORBAFIX ENHANCED FIXATION DEVICE FAILED TO SECURE THE MESH AFTER MULTIPLE ATTEMPTS. THE FIXATION WAS ATTEMPTED AT THE ABDOMINAL SOFT TISSUE WITH ADEQUATE COUNTER-PRESSURE; HOWEVER, THE FASTENERS FAILED TO DEPLOY AND SECURE. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT, AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, THE SURGEON HAD PRIOR EXPERIENCE USING THIS PRODUCT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25410442 ↗
• MalfunctionMay 8, 2026Failure to Form Staple

  AS REPORTED, ON (B)(6) 2026 DURING A PROMONTOFIXATION SURGERY USING A SORBAFIX ENHANCED FIXATION DEVICE NONE OF THE FASTENERS WERE FIXATED SUCCESSFULLY AND THE STAPLES DID NOT HOLD. AS SUCH THE PROSTHESIS WAS SECURED WITH SUTURES. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25124856 ↗
• MalfunctionApr 16, 2026Failure to Form Staple

  AS REPORTED, DURING A BILATERAL HERNIOPLASTY PROCEDURE SORBAFIX ENHANCED FASTENER DID NOT SECURE THE MESH AT FIRST SHOT AND NO FASTENERS WERE FIXED SUCCESSFULLY EVEN THOUGH THE RIGHT PRESSURE WAS APPLIED. THE LOOSE FASTENERS WERE NOT REMOVED FROM THE PATIENT'S BODY. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24904190 ↗
• MalfunctionApr 14, 2026Failure to Form Staple

  AS REPORTED ON (B)(6) 2026, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE THE SORBAFIX ENHANCED DEVICE FAILED TO FIXATE THE MESH. IT WAS REPORTED THAT A PORTION OF MESH WAS STAPLED TO THE PERITONEUM, AND THE REMAINING FASTENERS BECAME LOOSE AND FELL. A CAPSURE DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, AND THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT¿S BODY. THERE WAS NO PATIENT/USER HARM OR INJURY. AS REPORTED SURGEON IS THE FIRST-TIME USER OF THE SORBAFIX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875426 ↗
• InjuryApr 7, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH UMBILICAL HERNIA AND SUPRAUMBILICAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST WITH ECHO PS (DEVICE 1). PER OPERATION NOTES, "A PALMAR¿S POINT INCISION IN THE LEFT UPPER QUADRANT SKIN WAS INCISED. A SUPRAUMBILICAL AND UMBILICAL HERNIA WAS IDENTIFIED. ANTERIOR ABDOMINAL WALL ADHESIONS WERE TAKEN DOWN AND DECOMPRESSED THE CHRONICALLY INCARCERATED UMBILICAL HERNIA. HERNIA CONTENTS WERE OLD OMENTAL FAT AND APPEARED TO BE AN ADDITIONAL SUPRA UMBILICAL DEFECT. SECOND SUPRAUMBILICAL DEFECT WAS NOTED. A VENTRALIGHT ST WITH ECHO PS (DEVICE 1) WAS PLACED INTO THE ABDOMEN AND SECURED WITH SUTURES AND SORBAFIX ENHANCED (DEVICE 2)." ON (B)(6) 2020 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA, FASCIA EROSION THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF SORBAFIX ENHANCED (DEVICE 2) AND IMPLANT OF VENTRALEX ST MESH (DEVICE 3). PER OPERATION NOTES, "AN INCISION WAS MADE ABOVE THE SUPRAUMBILICAL REGION. AN ERODED SORBAFIX ENHANCED (DEVICE 2) WAS NOTED IN THE SUBCUTANEOUS TISSUES OF UPPER LEFT INCISION AND IT WAS REMOVED. PROMINENT TACK WAS AGAIN NOTED AT THE MID-LEFT INCISION AND IT WAS REMOVED

  Patient problems: Erosion

  MAUDE report 24801207 ↗
• MalfunctionMar 25, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC LEFT INGUINAL PROCEDURE USING A SORBAFIX ENHANCED FIXATION DEVICE, DEVICE FASTENERS DID NOT PENETRATE THE TISSUE PROPERLY AND FAILED TO FIXATE THE PROSTHESIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690635 ↗
• MalfunctionMar 25, 2026Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE USING THE SORBAFIX ENHANCED FIXATION DEVICE, THE FASTENERS DID NOT PENETRATE THE TISSUE PROPERLY AND FAILED TO FIXATE THE PROSTHESIS. NOTE, THE DATE OF PROCEDURE WAS NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24690624 ↗
• MalfunctionMar 6, 2026Failure to Form Staple

  AS REPORTED, DURING A UNILATERAL LEFT LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, SORBAFIX FIXATION DEVICE HAD ONLY TEN FASTENERS INSTEAD OF THIRTY FASTENERS. ADDITIONALLY, THE SORBAFIX FASTENERS FAILED TO PROPERLY FIXATE THE MESH WHILE FIXATING THE MESH AT PREPERITONEAL AREA. THE SURGEON USUALLY USES THREE FASTENERS BUT HAD TO USE 10 TO 15 FASTENERS TO SECURE THE MESH. THE PROCEDURE WAS COMPLETED USING SAME DEVICE AND IT WAS CONFIRMED THAT A SEPARATE DEVICE IS USED FOR EVERY PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535769 ↗
• MalfunctionFeb 20, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A SURGICAL PROCEDURE, THE SORBAFIX ENHANCED FIXATION DEVICE'S FASTENERS FAILED TO DEPLOY. THE FASTENERS FAILED TO COME OUT OF THE SHAFT OF THE DEVICE. WHEN THE SURGEON ATTEMPTED TO MOVE THE DEVICE OUTSIDE THE PATIENT'S CAVITY, IT FIRED AGAIN, RELEASING ALL THE FASTENERS OF THE STEEL COIL SIMULTANEOUSLY. IT WAS REPORTED THAT THE ISSUE IS BELIEVED TO HAVE OCCURRED DUE TO EXPOSURE TO HIGH TEMPERATURES DURING TRANSPORTATION, DESPITE THE DISTRIBUTOR BEING INSTRUCTED ON THE HANDLING AND TRANSPORTING PROCEDURES AND THE TEMPERATURE PRECAUTIONS. THERE WAS NO PATIENT INJURY. ADDENDUM PER ADDITIONAL INFORMATION PROVIDED: AS REPORTED, DURING A SURGICAL PROCEDURE ON (B)(6) 2026, THE JAM OCCURRED DURING ACTIVATION AT THE FIRST STAPLE. THE FASTENERS ARE CONTAINED WITHIN THE MANDREL AND COULD NOT BE REMOVED AS THEY WERE COMPLETELY GLUED. THE FIXATION WAS APPLIED DIRECTLY TO THE ABDOMINAL WALL, NOT TO ANY RIGID STRUCTURE, BONE, OR COOPER¿S LIGAMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401077 ↗
• MalfunctionFeb 19, 2026Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE ON (B)(6) 2026, THE SORBAFIX FIXATION DEVICE MALFUNCTIONED AND THE FASTENERS COULD NOT BE FASTENED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388978 ↗
• MalfunctionFeb 19, 2026Break

  AS REPORTED, DURING A PROCURE ON (B)(6) 2026 THE SORBAFIX ENHANCED FIXATION DEVICE WAS JAMMED WHILE BEING TRIGGERED OR ACTUATED. IT WAS STIFF FROM THE FIRST SHOT AND COULD NOT BE GRIPPED PROPERLY. THE SURGEON REMOVED THE DEVICE AND PERFORMED A DRY FIRE WHILE HOLDING IT FIRMLY, WHICH RESULTED IN THE RELEASE OF A DAMAGED FASTENER. ANOTHER SORBAFIX DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388481 ↗
• MalfunctionFeb 10, 2026Failure to Form Staple

  AS REPORTED, THE SORBAFIX STAPLES DID NOT FASTEN AND UPON APPLICATION OF THE FIRST STAPLE, THE PLATE WAS CAUSED TO ROTATE 360°, RESULTING IN THE PROCEDURE HAVING TO BE REPEATED. 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 24307459 ↗
• MalfunctionFeb 10, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE SORBAFIX ENHANCED FIXATION DEVICE FAILED TO SECURE THE MESH AND ANOTHER DEVICE WAS USED TO SECURE THE MESH DUE TO THE RISK OF MESH MIGRATION. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307456 ↗
• MalfunctionFeb 5, 2026Failure to Form Staple

  AS REPORTED, DURING IPOM PROCEDURE WHEN USING SORBAFIX ENHANCED FIXATION THE DEVICE DID NOT SHOOT PROPERLY AND THE MESH COULD NOT BE FIXED. THE FASTENER DETACHED AND FELL OUT AFTER 2¿3 FIXATIONS, WITH LOOSE OR PROTRUDING FASTENERS NOTED BUT NO DEFECTS IDENTIFIED. THERE WAS NO DAMAGE TO THE DEVICE TIP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270563 ↗
• MalfunctionFeb 5, 2026Break

  AS REPORTED, DURING EVENTRATION REPAIR PROCEDURE ON (B)(6) 2025, SORBAFIX ENHANCED DEPLOYED STAPLES WERE BRITTLE AND BROKE DURING INSERTION. THIS INCIDENT RESULTED IN A LOSS OF OPERATING TIME FOR THE TEAM AND EXCESSIVE CONSUMPTION OF MATERIALS. IT WAS ALSO REPORTED THAT NONE OF THE FASTENERS GOT FIRED SUCCESSFULLY AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270551 ↗
• MalfunctionJan 20, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, SORBAFIX ENHANCED FIXATION DEVICE FAIL TO SECURE THE SCREWS. THE PLATE (MESH) IS THEREFORE NOT FIXED. THE USE OF ANOTHER DEVICE IS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24115884 ↗
• MalfunctionJan 5, 2026Failure to Form Staple

  AS REPORTED, SORBAFIX STAPLES FAIL TO ATTACH AND FALL BACK INTO THE ABDOMEN. THE PROSTHESIS IS THEREFORE NOT FIXED AGAINST THE WALL. DELAY IN OPERATION. 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 23967029 ↗
• MalfunctionDec 17, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, SORBAFIX STAPLES FAILED TO ATTACH AND FALL BACK INTO THE ABDOMEN. THE PROSTHESIS WAS NOT FIXATED AND TIME LOST FOR REMOVAL OF THE LOOSE FASTENERS FROM THE PATIENT'S BODY. THERE WAS DELAY IN THE OPERATION TO SEARCH FOR GLUE IN DEPARTMENT TO REPLACE SORBAFIX. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23828899 ↗
• MalfunctionDec 16, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, SORBAFIX STAPLES FAIL TO ATTACH AND FALL BACK INTO THE ABDOMEN. THE PROSTHESIS IS THEREFORE NOT FIXED AGAINST THE WALL. TIME LOST DURING REMOVAL OF THE LOOSE FASTENERS FROM THE PATIENT'S BODY. DELAY IN OPERATION TO SEARCH FOR GLUE IN DEPARTMENT TO REPLACE SORBAFIX. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816613 ↗
• MalfunctionDec 16, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, SORBAFIX STAPLES FAIL TO ATTACH AND FALL BACK INTO THE ABDOMEN. THE PROSTHESIS IS THEREFORE NOT FIXED AGAINST THE WALL. TIME LOST DURING REMOVAL OF THE LOOSE FASTENERS FROM THE PATIENT'S BODY. DELAY IN OPERATION TO SEARCH FOR GLUE IN DEPARTMENT TO REPLACE SORBAFIX. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816610 ↗
• MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, SORBAFIX STAPLES FAIL TO ATTACH AND FALL BACK INTO THE ABDOMEN. THE PROSTHESIS IS THEREFORE NOT FIXED AGAINST THE WALL. TIME LOST DURING REMOVAL OF THE LOOSE FASTENERS FROM THE PATIENT'S BODY. DELAY IN OPERATION TO SEARCH FOR GLUE IN DEPARTMENT TO REPLACE SORBAFIX. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803664 ↗
• MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, SORBAFIX STAPLES FAIL TO ATTACH AND FALL BACK INTO THE ABDOMEN. THE PROSTHESIS IS THEREFORE NOT FIXED AGAINST THE WALL. TIME LOST DURING REMOVAL OF THE LOOSE FASTENERS FROM THE PATIENT'S BODY. DELAY IN OPERATION TO SEARCH FOR GLUE IN DEPARTMENT TO REPLACE SORBAFIX. THERE WAS NO REPORTED PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803181 ↗
• MalfunctionDec 15, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, SORBAFIX STAPLES FAIL TO ATTACH AND FALL BACK INTO THE ABDOMEN. THE PROSTHESIS IS THEREFORE NOT FIXED AGAINST THE WALL. TIME LOST DURING REMOVAL OF THE LOOSE FASTENERS FROM THE PATIENT'S BODY. DELAY IN OPERATION TO SEARCH FOR GLUE IN DEPARTMENT TO REPLACE SORBAFIX. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803180 ↗