CAPSURE 0113230Recalls & reported problems

Summary

The FDA's MAUDE database contains 75 adverse event reports that list this exact device (DI 00801741094996), received between Nov 6, 2017 and Jul 3, 2026 — classified as 9 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Failure to Form Staple” (36 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 25 most recent of 75 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 17, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  AS REPORTED, DURING IPOM PROCEDURE THERE WAS BLOOD STAIN MARKS NOTED ON THE FIRING HANDLE OF THE CAPSURE FIXATION DEVICE. THE PRODUCT PACKAGING WAS INTACT, AND THE INNER PACKAGING WAS COMPLETELY SEALED BEFORE OPENING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829331 ↗
• MalfunctionOct 27, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, A LAPAROSCOPIC FEMORAL AND UMBILICAL HERNIA REPAIR WAS PERFORMED USING THE CAPSURE FIXATION DEVICE. PER INFORMATION REPORTED, NO FASTENERS WERE DISPENSED INITIALLY WHEN THE DEVICE FAILED TO FUNCTION PROPERLY. WHEN THE DEVICE DID WORK, IT DISPENSED TWO FASTENERS SIMULTANEOUSLY. THE SPECIFIC PROCEDURE DURING WHICH THE ISSUE OCCURRED AND WHETHER THE FASTENERS WERE LEFT IN PLACE WERE UNKNOWN. THE DEVICE WAS DISCARDED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A NEW CAPSURE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23390523 ↗
• MalfunctionOct 1, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE THE CAPSURE FIXATION DEVICE FAILED TO FIXATE PROPERLY, AND THE FASTENERS FELL INTO THE ABDOMEN. THERE WAS NO REPORTED PATIENT INJURY. ADDENDUM: AS REPORTED, ON (B)(6) 2025 DURING A IPOM PROCEDURE, WHILE DEPLOYING FASTENERS TO THE PERITONEUM THE CAPSURE FIXATION DEVICE FAILED TO FIXATE PROPERLY. IT WAS REPORTED THAT FOUR FASTENERS GOT FIXATED SUCCESSFULLY AND THE PRESENTED LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPSURE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23193321 ↗
• MalfunctionAug 8, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC ABDOMINAL WALL INCISIONAL HERNIA REPAIR PROCEDURE A CAPSURE FIXATION DEVICE USED TO FIXATE AN UNKNOWN MESH. IT WAS REPORTED THAT THE FASTENER GOT CAUGHT ON THE MESH FROM THE FIRST ATTEMPT AND THE TIP OF THE SHAFT COULD NOT BE REMOVED. IT WAS ALSO REPORTED THAT THE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748751 ↗
• MalfunctionJun 10, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING THE LAPAROSCOPIC INCISIONAL HERNIA (IPOM-PLUS) REPAIR PROCEDURE USING VENTRALIGHT ST MESH, THE CAPSURE DEVICE WAS UNABLE TO SECURE THE MESH PROPERLY AND AFTER FASTENERS WERE INSERTED, THERE WERE THREE CONSECUTIVE CASES WHERE THE FASTENERS DID NOT COME OUT OF THE SHAFT PROPERLY AND CAME OFF THE MESH. IT WAS REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175691 ↗
• MalfunctionMay 8, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING LAPAROSCOPIC ABDOMINAL IPOM INCISIONAL HERNIA SURGERY WHILE USING CAPSURE FIXATION DEVICE, NEARLY 10 FASTENERS DID NOT FIXATE THE MESH/TISSUE. FASTENERS THAT WERE NOT COMPLETELY FIXATED WERE REMOVED FROM PATIENT. THE PROCEDURE WAS COMPLETED USING A NON-BD DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21985382 ↗
• MalfunctionMar 14, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING BILATERAL INGUINAL PLASTY HERNIA REPAIR PROCEDURE, THE CAPSURE FIXATION DEVICE WAS USED AND WHEN PRESSURE WAS APPLIED, THE DEVICE DEPLOYED TWO FASTENERS IN A SINGLE FIRE. IT WAS REPORTED THAT ANOTHER DEVICE WAS REQUESTED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607498 ↗
• MalfunctionMar 14, 2025Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE WITH VENTRALIGHT ST W/ ECHO PS USING CAPSURE FIXATION DEVICE (30 CT), IT WAS REPORTED THAT THE FIXATION DEVICE WAS NOT FIRING CORRECTLY. TWENTY-SEVEN (27) FASTENERS WERE FIXATED SUCCESSFULLY, BUT THERE WERE 3 FASTENERS THAT FIXATED LOOSELY ON THE MESH. THE 3 LOOSE FASTENERS WERE REMOVED. THE 27 FASTENERS THAT WERE SUCCESSFULLY DEPLOYED WERE SUFFICIENT FOR THE SIZE MESH, AS SUCH NO ADDITIONAL FIXATION WAS REQUIRED. THE SURGEON IS VERY EXPERIENCED WITH THIS PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21604761 ↗
• MalfunctionMar 5, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING INGUINAL HERNIA REPAIR, THE SURGEON TRIED TO FIXATE THE 3DMAX LIGHT MESH USING CAPSURE FIXATION DEVICE. IT WAS REPORTED THAT DEVICE DEPLOYED THREE FASTENERS IN TANDEM ON ONE ATTEMPT WHICH WERE FOUND TO BE DEPLOYED INTO ONE ANOTHER. AS REPORTED, THIS ISSUE OCCURRED ONCE DURING USE OF THE 30-FASTENER DEVICE. THE 3 TANDEM FASTENERS FAILED TO FIXATE THE MESH, AND THE DEVICE WAS NOT USED IN HARD STRUCTURE. THE PROCEDURE WAS COMPLETED WITH SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21526758 ↗
• MalfunctionMar 3, 2025Unintended Ejection; Failure to Form Staple; Unintended Ejection; Failure to Form Staple

  AS REPORTED, DURING A TRANSABDOMINAL PREPERITONEAL HERNIA REPAIR OF GROIN HERNIA, CAPSURE FIXATION DEVICE DEPLOYED THE FASTENERS WHICH DID NOT FIXATE INTO THE MESH AND TISSUES FULLY. IT WAS REPORTED THAT SOME OF THE FASTENERS WERE DEPLOYED TWO FASTENERS AT A TIME. THE REPORTED PROBLEM OCCURRED AFTER THIRD FIRE IN WHICH FIRST 3 FASTENERS WERE FIRED GOOD. IT WAS REPORTED THAT PARTIALLY FIXATED FASTENER AND SOME DEPLOYED CONNECTED FASTENERS WERE REMOVED FROM THE PATIENT'S BODY. IT WAS REPORTED THAT ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE AND THERE WAS DELAY IN SURGERY TIME AND ANESTHESIA. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507155 ↗
• MalfunctionJan 29, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING IPOM PLUS VENTRAL HERNIA REPAIR PROCEDURE, THE CAPSURE FIXATION DEVICE DEPLOYED TWO FASTENERS AT A SINGLE FIRE. IT WAS REPORTED THAT THE ISSUE OCCURRED AFTER FOURTH FASTENER AND SURGEON WAS NOT ABLE TO REMOVE THE TWO FASTENERS FROM PATIENT'S BODY. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE. THERE WAS SURGICAL DELAY, AND NO PATIENT HARM OR SERIOUS INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21265979 ↗
• MalfunctionJan 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING A SACROCOLPOPEXY SURGERY, THE CAPSURE FIXATION DEVICE DID NOT FIRE THE FASTENER AND TRIGGER WAS STUCK. IT WAS REPORTED THAT A COMPETITOR PRODUCT WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY. DURING SAMPLE EVALUATION IT WAS FOUND THAT THERE WAS A DETACHED AND MISSING INTERNAL COMPONENT THAT YIELDED A NONFUNCTIONAL DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21242177 ↗
• MalfunctionJan 21, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, DURING INTRAPERITONEAL-ONLAY-MESH REPAIR (IPOM PLUS), THE FASTENERS OF CAPSURE DEVICE DID NOT COME OUT AFTER 3 TO 4 FASTENERS GOT FIRED SUCCESSFULLY. IT WAS REPORTED THAT TRIGGER FUNCTIONED NORMAL AND SURGEON DRY FIRED THE DEVICE OUTSIDE TO CHECK BUT PROBLEM REMAIN SAME. THE SURGEON USED ANOTHER FIXATION TO COMPLETE SURGERY, WHICH INCREASED SURGERY TIME BY 35-40 MINUTES. IT WAS REPORTED THAT NO OTHER MEDICAL INTERVENTION WAS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21197754 ↗
• MalfunctionJan 17, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, CAPSURE WAS USED TO FIXATE THE MESH TO THE ABDOMINAL WALL. IT WAS REPORTED THAT THE DEVICE DEPLOYED TWO FASTENERS OVERLAPPING WHEN THE TRIGGER WAS PULLED. IT WAS REPORTED THAT THE DEPLOYED MULTIPLE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED AS IT WAS AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21178461 ↗
• MalfunctionJan 8, 2025Unintended Ejection; Unintended Ejection

  AS REPORTED, THE CAPSURE FIXATION DEVICE MISFIRES AND DEPLOYED TWO FASTENERS. IT WAS REPORTED THAT THE ADDITIONAL FASTENER WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE FROM A DIFFERENT LOT NUMBER. IT WAS REPORTED THE SAMPLE WAS DISCARDED AND THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21101566 ↗
• MalfunctionNov 15, 2024Unintended Ejection; Failure to Form Staple; Unintended Ejection; Failure to Form Staple

  AS REPORTED, DURING A PROCEDURE CAPSURE STRAIGHT FIXATION DEVICE WAS USED. IT WAS REPORTED THAT THE DEVICE DID NOT FIRE INSIDE THE ABDOMINAL CAVITY AND WHEN FIRED OUTSIDE TWO FASTENERS DEPLOYED AT A TIME, THIS HAPPENED THREE TIME IN A ROW. IT WAS ALSO REPORTED THAT NO LOOSE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND ANOTHER CAPSURE FIXATION DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 20695886 ↗
• MalfunctionNov 12, 2024Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING A PROCEDURE WHEN SURGEON TRIED TO FIXATE THE 3DMAX MESH USING CAPSURE FIXATION DEVICE (DEVICE #1), THE DEVICE DEPLOYED MULTIPLE FASTENERS AT A TIME, AND SOME WERE NOT PROPERLY FIXED. IT WAS REPORTED THAT THE SURGEON OPENED THE SECOND CAPSURE DEVICE (DEVICE #2) AND EXPERIENCED A SIMILAR SCENARIO. IT WAS ALSO REPORTED THAT THE DEPLOYED MULTIPLE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING ANOTHER FIXATION DEVICE OF A DIFFERENT BRAND. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE #2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663042 ↗
• MalfunctionNov 12, 2024Unintended Ejection; Unintended Ejection

  AS REPORTED, DURING A PROCEDURE WHEN SURGEON TRIED TO FIXATE THE 3DMAX MESH USING CAPSURE FIXATION DEVICE (DEVICE #1), THE DEVICE DEPLOYED MULTIPLE FASTENERS AT A TIME, AND SOME WERE NOT PROPERLY FIXED. IT WAS REPORTED THAT THE SURGEON OPENED THE SECOND CAPSURE DEVICE (DEVICE #2) AND EXPERIENCED A SIMILAR SCENARIO. IT WAS ALSO REPORTED THAT THE DEPLOYED MULTIPLE FASTENERS WERE REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED USING ANOTHER FIXATION DEVICE OF A DIFFERENT BRAND. THERE WAS NO PATIENT INJURY. THIS FILE REPRESENTS DEVICE #1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662939 ↗
• MalfunctionOct 30, 2024Failure to Form Staple; Failure to Form Staple

  AS REPORTED, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE THE CAPSURE DEVICE WAS USED TO FIXATE THE MESH. IT WAS REPORTED THAT THE DEVICE DEPLOYED ABOUT 10 FASTENERS SUCCESSFULLY BUT THEN A COUPLE OF THE FASTENERS DID NOT FIXATE THE MESH FULLY, THESE LOOSE FASTENERS WERE REMOVED FROM THE PATIENT AND THE SURGEON FINISHED THE PROCEDURE BY USING A NEW CAPSURE DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569584 ↗