SORBAFIXRecalls & reported problems across all models

We found 2 models of SORBAFIX by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 270 adverse event reports in the FDA's MAUDE database, received between Jul 28, 2017 and Sep 3, 2026 — classified as 10 injuries, 260 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (170 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported SORBAFIX problems

SORBAFIX models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• SORBAFIX 0113116

  STAPLE, IMPLANTABLE
  162 reports
• SORBAFIX 0113115

  STAPLE, IMPLANTABLE
  108 reports

Recent SORBAFIX adverse event reports

The 15 most recent reports across all models, 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 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 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 ↗
• 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 ↗
• 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 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 ↗

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