CAPSURERecalls & reported problems across all models

We found 2 models of CAPSURE by Davol Inc. in the FDA's device registry (GUDID). Together they are named in 223 adverse event reports in the FDA's MAUDE database, received between Nov 6, 2017 and Sep 8, 2026 — classified as 22 injuries, 201 malfunctions.

The most frequently reported specific device problem is “Unintended Ejection” (75 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 CAPSURE problems

CAPSURE models

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

• CAPSURE 0113215

  STAPLE, IMPLANTABLE
  148 reports
• CAPSURE 0113230

  STAPLE, IMPLANTABLE
  75 reports

Recent CAPSURE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Unintended Ejection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50670402 ↗
• InjuryJul 3, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH INCISIONAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST (DEVICE 1) AND CAPSURE STRAIGHT (DEVICE 2). PER OP NOTES, ¿THE HERNIA SAC WAS NOTED WITH SCARRED UP OMENTUM. THE OMENTUM WAS REDUCED. THE INCARCERATED FAT WAS REDUCED. SOME FAT WAS EXCISED AND REMOVED. A VENTRALIGHT ST MESH (DEVICE 1) WAS PLACED AND SECURED USING PROLENE SUTURES. THE MESH WAS THEN TACKED CIRCUMFERENTIALLY USING CAPSURE STRAIGHT (DEVICE 2) TACKS.¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT INCISIONAL HERNIA AND ABDOMINAL PAIN SECONDARY TO FIXATION DEVICE THEREBY UNDERWENT OPEN REPAIR WITH EXCISION OF VENTRALIGHT ST (DEVICE 1), CAPSURE STRAIGHT (DEVICE 2) AND IMPLANT OF BIOLOGICAL MESH. PER OP NOTES, ¿THE DEVITALIZED SKIN AND SUBCUTANEOUS TISSUES IN THE MIDLINE WAS EXCISED. THE HERNIA SAC WAS IDENTIFIED AND OPENED. ADHESIONS OF OMENTUM TO ANTERIOR ABDOMINAL WALL WERE TAKEN DOWN. THE PREVIOUS MESH (DEVICE 1) WAS NOTED AND EXCISED ALONG WITH CAPSURE STRAIGHT (DEVICE 2) TACKS. THE HERNIA SAC WAS EXCISED AND REMOVED. MYOFASCIAL FLAPS WERE RAISED BILATERALLY. A BIOLOGICAL MESH WAS PLACED AND SUTURED.¿

  Patient problems: Abdominal Pain

  MAUDE report 25706950 ↗
• MalfunctionJun 25, 2026Failure to Form Staple

  AS REPORTED, DURING A TAPP PROCEDURE, THE CAPSURE FASTENERS DID NOT SEAT PROPERLY, AND ALL WERE FEW MILLIMETERS LOOSE. REPORTEDLY, COUNTER-PRESSURE WAS APPLIED AS USUAL, THE AREA OF TARGET WAS LIGAMENTS AND ABDOMINAL SOFT TISSUE. AN ALTERNATE DEVICE WAS USED TO COMPLETED THE PROCEDURE WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25621841 ↗
• MalfunctionJun 24, 2026Failure to Form Staple

  AS REPORTED, ON (B)(6) 2026 DURING A TAPP PROCEDURE USING CAPSURE STRAIGHT FIXATION DEVICE, NO RESISTANCE WAS FELT DURING THE FIRST FASTENER DEPLOYMENT, CAUSING THE FASTENERS TO SLIP OUT. THE DEVICE FUNCTIONED NORMALLY AFTER THE FIRST FIRE. REPORTEDLY, PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITHOUT ANY FURTHER COMPLICATION. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25613904 ↗
• InjuryMay 19, 2026Patient-Device Incompatibility

  PER INFORMATION PROVIDED: ON (B)(6) -2016 - PATIENT WAS DIAGNOSED WITH SUPRAUMBILICAL AND UMBILICAL HERNIAS THEREBY UNDERWENT LAPAROSCOPIC REPAIR WITH IMPLANT OF VENTRALIGHT ST WITH ECHO PS (DEVICE 1) AND CAPSURE STRAIGHT. PER OP NOTES, ¿A SMALL INCISION WAS MADE IN THE LEFT UPPER QUADRANT. A VENTRALIGHT ST WITH ECHO PS (DEVICE 1) WAS PLACED AND SECURED WITH CAPSURE STRAIGHT (DEVICE 2).¿ ON (B)(6) 2019 - PATIENT WAS DIAGNOSED WITH RECURRENT VENTRAL HERNIA THEREBY UNDERWENT LAPAROSCOPIC/ROBOTIC ASSISTED REPAIR WITH EXCISION OF VENTRALIGHT ST WITH ECHO PS (DEVICE 1) AND CAPSURE STRAIGHT (DEVICE 2). PER OP NOTES, ¿A SMALL INCISION WAS MADE IN THE LEFT UPPER QUADRANT. OMENTUM WAS NOTED TO BE ADHERENT TO THE ABDOMINAL MESH AND COMPLETELY DETACHED. THE VENTRALIGHT ST WITH ECHO PS (DEVICE 1) AND CAPSURE STRAIGHT (DEVICE 2) WERE EXPLANTED. RECURRENT UMBILICAL DEFECT WAS PRIMARILY REPAIRED WITH SUTURE.¿

  Patient problems: Pain

  MAUDE report 25221209 ↗
• MalfunctionMay 1, 2026Material Twisted/Bent

  AS REPORTED, DURING A PROCEDURE THE ZIPPER (FASTENER) ON THE CAPSURE STRAIGHT WAS WARPED AND IT COULDN'T BE USED. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25055635 ↗
• MalfunctionApr 24, 2026Expulsion

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE USING CAPSURE ON A PATIENT, THE FASTENER PROTRUDED THROUGH THE SKIN. REPORTEDLY, THE PROTRUSION HAPPENED IMMEDIATELY AFTER THE FIXATION DURING THE PROCEDURE AND THE PENETRATED FASTENER PROBABLY LEFT IN PATIENT. IT IS BELIEVED THAT THE TIP OF THE FASTENER PROTRUDED SLIGHTLY BEYOND THE SKIN DUE TO THE PATIENT HAVING THIN SKIN (THIN BUILD) AND THE APPLICATION OF EXCESSIVE COUNTER PRESSURE DURING FIXATION. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24983494 ↗
• MalfunctionMar 25, 2026Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC TAPP PROCEDURE, THE CAPSURE DEVICE TRIGGER FELT LOOSE AND DID NOT FIXATE THE FASTENERS PROPERLY. SOME FASTENERS WERE REPORTEDLY PLACED LOOSELY OR DISLODGED COMPLETELY, AND AFTER MULTIPLE TRIGGER PULLS, THE DEVICE BECAME JAMMED. THE LOOSE FASTENERS WERE RETRIEVED FROM THE PATIENT¿S BODY AND THE PROCEDURE WAS COMPLETED USING A NEW CAPSURE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686450 ↗
• MalfunctionMar 3, 2026Unintended Ejection

  AS REPORTED, DURING A TAPP PROCEDURE, TWO FASTENERS OF THE CAPSURE DEVICE CAME OUT SIMULTANEOUSLY DURING DRY FIRING. ANOTHER SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24500444 ↗
• MalfunctionFeb 25, 2026Unintended Ejection

  AS REPORTED, DURING A PROCEDURE USING CAPSURE FIXATION DEVICE, TWO FASTENERS WERE DEPLOYED IN A ROW. IT WAS REPORTED THAT TWO FASTENERS GOT FIXATED SUCCESSFULLY AND THE LOOSE FASTENERS WERE REMOVED FROM PATIENT'S BODY. THE FIXATION WAS APPLIED INTO A HARD STRUCTURE/BONE/COOPER¿S LIGAMENT ALSO THE SURGEON HAS PERFORMED DRY FIRE TO CHECK IF THE PROBLEM RE-OCCURRED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24446080 ↗
• MalfunctionFeb 24, 2026Failure to Form Staple

  AS REPORTED, DURING A VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2026, THE CAPSURE FIXATION DEVICE FASTENERS FAILED TO FIXATE THE MESH PROPERLY INTO THE PERITONEUM AND GOT STUCK IN THE MESH. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND THE MESH WAS FIXATED WITH SUTURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431600 ↗
• MalfunctionFeb 19, 2026Failure to Form Staple

  AS REPORTED, DURING A TAPP PROCEDURE ON (B)(6) 2026, WHEN USING THE CAPSURE FIXATION DEVICE THE FIRST FASTENER FAILED TO PENETRATE THE MESH INTO FASCIA. IT WAS REPORTED THAT 8 FASTENERS WERE FIRED AROUND THE CIRCUMFERENCE, BUT NONE OF THEM WERE FULLY FIXATED AND BECAME LOOSE WHEN THE MESH WAS SLIGHTLY PULLED. ANOTHER CAPSURE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388318 ↗
• MalfunctionFeb 17, 2026Detachment of Device or Device Component

  AS REPORTED, DURING A PROCEDURE USING CAPSURE FIXATION DEVICE DURING FIXATION, THE FIRST FASTENER WAS DEPLOYED WITHOUT THE FASTENER CAP OBSERVED AND FURTHERMORE, WHEN THE TRIGGER WAS PULLED, NO FASTENER WAS EJECTED. REPORTEDLY, THE FASTENERS WERE NOT FIXED TO A RIGID STRUCTURE/BONE/COOPER'S LIGAMENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24364811 ↗
• MalfunctionDec 23, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, CAPSURE FIXATION DEVICE FAILED TO FIXATE. THREE FASTENERS WHICH WERE RELEASED FROM THE DEVICE WERE DIFFICULT TO INSERT AND DID NOT PENETRATE THE TISSUE DEEPLY, LEAVING A GAP BETWEEN THE MESH AND ABDOMINAL WALL. IT WAS REPORTED THAT THE THREE FASTENERS THAT DID NOT PENETRATE COMPLETELY WERE LEFT IN THE PATIENT'S BODY. ANOTHER CAPSURE DEVICE WAS THEN USED ALLOWING THE PROCEDURE TO FINISH WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23877558 ↗
• MalfunctionDec 18, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, THE CAPSURE FIXATION DEVICE FASTENERS FAILED TO ADHERE TO PATIENT'S ABDOMINAL WALL AND SOME OF THE FASTENERS WERE BARELY FIXATED. THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND ANOTHER FIXATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838940 ↗

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