Capio SLIM M0068318250Recalls & reported problems

Summary

The FDA's MAUDE database contains 196 adverse event reports that list this exact device (DI 08714729838005), received between Dec 1, 2016 and Jul 2, 2026 — classified as 23 injuries, 173 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (83 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 27, 2024Open, Classified

   Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.

   Z-2452-2024 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 196 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT, DURING THE USE OF A CAPIO SLIM DEVICE, THE SUTURE DETACHED FROM THE DART DURING SURGERY. THE PHYSICIAN USED THE STANDARD TECHNIQUE DURING DEPLOYMENT OF THE SUTURE. AN ATTEMPT WAS MADE TO RECOVER THE DART, BUT IT COULD NOT BE FOUND. IT, ALONG WITH PART OF THE SUTURE, REMAINED IN THE PATIENT. THE PROCEDURE WAS THEN CANCELLED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25692595 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO SLIM, THE BULLET DETACHED FROM THE SUTURE ON TWO SEPARATE MONODEK SUTURES. INITIALLY, THE BULLET WAS THOUGHT TO BE LODGED IN THE PELVIS; HOWEVER, IT WAS LATER DETERMINED TO BE RETAINED WITHIN THE CHANNEL ON THE CAPTURE SIDE OF THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25127208 ↗
• MalfunctionApr 1, 2026Break

  IT WAS REPORTED THAT A CAPIO SLIM DEVICE WAS USED DURING A PROLAPSE PROCEDURE. DURING PROCEDURE, THE DEVICE REPORTEDLY BROKE/FRACTURED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. THE EVENT DESCRIPTION MAY SUGGEST THAT THE CARRIER BROKE. THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756776 ↗
• MalfunctionMar 19, 2026Misfire

  IT WAS REPORTED THAT A CAPIO SLIM DEVICE WAS USED DURING A PROLAPSE PROCEDURE PERFORMED ON (B)(6) 2026. DURING PROCEDURE, THE DEVICE MISFIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645142 ↗
• MalfunctionNov 24, 2025Misfire; Misfire

  IT WAS REPORTED THAT A CAPIO DEVICE MISFIRED DURING THE PROCEDURE, AND AN ALTERNATE DEVICE WAS USED TO COMPLETE IT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632931 ↗
• InjuryOct 31, 2025Nonstandard Device; Detachment of Device or Device Component; Nonstandard Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO SLIM DEVICE, THE SUTURE WAS INADVERTENTLY CUT, RESULTING IN THE NEEDLE AND THREAD TEMPORARILY REMAINING INSIDE THE PATIENT. A SUBSEQUENT COMPUTED TOMOGRAPHY (CT) SCAN IDENTIFIED THE LOCATION OF THE DART, WHICH WAS SUCCESSFULLY REMOVED USING COOPER FORCEPS WITHOUT THE NEED FOR ADDITIONAL INVASIVE INTERVENTION. NO FURTHER PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23441711 ↗
• MalfunctionSep 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TRANSVAGINAL MESH (TVM) PROCEDURE USING A CAPIO SLIM DEVICE, AFTER LOADING THE DART INTO THE CARRIER, THE SUTURE WAS PULLED BACK AND TENSIONED ALONG THE CAPIO HANDLE. AFTER THE DEVICE WAS FULLY DEPLOYED, THE NEEDLE BROKE OFF FROM THE THREAD ON THE PATIENT'S RIGHT SIDE, RESULTING THE DART TO BE DETACHED DURING SECURING AND THE DART REMAINED INSIDE THE PATIENT'S BODY. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23083657 ↗
• MalfunctionSep 2, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR REPAIR WITH SACROSPINOUS FIXATION PROCEDURE USING A CAPIO SLIM, THERE WAS DIFFICULTY DEPLOYING THE NEEDLE. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN. SINCE THE PROCEDURE TOOK PLACE IN A GOVERNMENT HOSPITAL, THE PATIENT WILL BE RE-BOOKED ONCE OPERATING THEATRE TIME BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22943542 ↗
• MalfunctionAug 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT VAULT FIXATION PROCEDURE FOR VAGINAL VAULT PROLAPSE USING A CAPIO SLIM, THE DEVICE WOULDN'T CAPTURE THE NEEDLE. A SECOND CAPIO SLIM WAS USED; HOWEVER, THIS DEVICE WOULD NOT CAPTURE THE NEEDLE EITHER. THE VAULT FIXATION PROCEDURE WAS THEN CANCELLED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN. THE PHYSICIAN WILL WAIT AND SEE HOW THE PATIENT HEALS AND THEN DECIDE IF A FURTHER PROCEDURE IS REQUIRED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-60165 FOR THE SECOND CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911813 ↗
• MalfunctionAug 28, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT VAULT FIXATION PROCEDURE FOR VAGINAL VAULT PROLAPSE USING A CAPIO SLIM, THE DEVICE WOULDN'T CAPTURE THE NEEDLE. A SECOND CAPIO SLIM WAS USED; HOWEVER, THIS DEVICE WOULD NOT CAPTURE THE NEEDLE EITHER. THE VAULT FIXATION PROCEDURE WAS THEN CANCELLED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN. THE PHYSICIAN WILL WAIT AND SEE HOW THE PATIENT HEALS AND THEN DECIDE IF A FURTHER PROCEDURE IS REQUIRED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-60161 FOR THE FIRST CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911812 ↗
• MalfunctionAug 27, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A SACROCOLPOPLEXY PROCEDURE USING A CAPIO SLIM, THE DEVICE MISFIRED. ANOTHER OF SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22903146 ↗
• MalfunctionAug 5, 2025Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A LIGAMENT HYSTEROPEXY PROCEDURE USING A CAPIO SLIM DEVICE, THE DEVICE FAILED TO PROPERLY ANCHOR THE SUTURE. IT WAS ALSO REPORTED THAT AFTER LOADING THE DART INTO THE CARRIER, THE SUTURE WAS PULLED BACK AND TENSIONED ALONG THE CAPIO HANDLE. AFTER THE DEVICE WAS FULLY DEPLOYED, THE SUTURE THREAD BROKE ON THE PATIENT'S LEFT SIDE, AND THE SUTURE NEEDLE REMAINED WITHIN THE TISSUE. AS A RESULT OF THIS, THE PROCEDURE WAS NOT COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22720553 ↗
• MalfunctionJul 31, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO SLIM DEVICE, THE SUTURE WAS STUCK INSIDE WHEN THE FORCEPS WERE RELEASED. ANOTHER CAPIO SLIM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22683502 ↗
• MalfunctionJul 24, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A TRANSVAGINAL MESH PROCEDURE USING A CAPIO SLIM DEVICE, THE NEEDLE COULD NOT BE ATTACHED, AND THE SUTURE THREAD COULD NOT BE RETRACTED. A SECOND CAPIO SLIM DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592452 ↗
• InjuryJul 18, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT, DURING A VAGINAL PROLAPSE REPAIR PROCEDURE USING A CAPIO SLIM DEVICE, THE CARRIER FAILED TO RETRACT AND BECAME STUCK IN THE TISSUE, RESULTING IN A VEIN INJURY AND SIGNIFICANT BLEEDING. THE EVENT WAS CLASSIFIED AS LIFE-THREATENING. THE PHYSICIANS COLLABORATED TO CONTROL THE HEMORRHAGE IN OPTIMAL CONDITIONS AS QUICKLY AS POSSIBLE.THE PATIENT WAS INITIALLY STABILIZED, AND THE PROCEDURE WAS COMPLETED; HOWEVER, A RECURRENCE OF BLEEDING LED TO HEMODYNAMIC INSTABILITY. THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR FURTHER SURGICAL INTERVENTION VIA A LAPAROSCOPY/MIDLINE APPROACH, DURING WHICH HEMOSTASIS WAS ACHIEVED UNDER COMPLEX CONDITIONS. SHE WAS THEN TRANSFERRED TO ANOTHER HOSPITAL IN A STABLE CONDITION FOR POTENTIAL EMBOLIZATION, AS A REOPERATION POSED SIGNIFICANT RISK. NO ADDITIONAL PROCEDURES WERE NECESSARY, AND THE PATIENT IS UNDER ROUTINE FOLLOW-UP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22543675 ↗
• MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CAPIO SLIM DEVICE WAS USED DURING A RICHTER PROCEDURE. WHILE PASSING THROUGH THE SACROSPINOUS LIGAMENT, THE NEEDLE DETACHED. IT WAS NOTED THAT THE NEEDLE REMAINED IN PLACE IN THE PATIENT'S PELVIS AND COULD NOT BE RETRIEVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS NOR ADDITIONAL ACTIONS TAKEN BY THE HEALTHCARE FACILITY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22471953 ↗
• MalfunctionJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT FIXATION (VAGINAL PROLAPSE REPAIR) PROCEDURE USING A CAPIO SLIM DEVICE, AFTER LOADING THE DART INTO THE CARRIER, THE SUTURE WAS PULLED BACK AND TENSIONED ALONG THE CAPIO HANDLE. AFTER THE DEVICE WAS FULLY DEPLOYED, THE DART DETACHED AND FELL INTO THE PATIENT. DESPITE USING AN X-RAY IMAGING AND PEELING THE LIGAMENT LAYERS, THE SURGICAL TEAM WAS UNABLE TO LOCATE OR RETRIEVE THE DART, WHICH REMAINED IN THE SACROSPINOUS LIGAMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22192124 ↗
• MalfunctionJun 3, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS FIXATION PROCEDURE USING A CAPIO SLIM DEVICE, THE DART DETACHED. THE PHYSICIAN TRIED TO REMOVE THE DART BY TRYING TO FEEL AND REMOVE THE DART BY THE HAND BUT THEN DECIDED TO LEAVE IT IN THE PATIENT. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22137052 ↗
• MalfunctionMay 21, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO SLIM, THE DEVICE DID NOT FIRE CORRECTLY. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22062013 ↗
• MalfunctionApr 23, 2025Use of Device Problem; Misfire; Use of Device Problem; Misfire

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT FIXATION FOR REPAIRING THE VAGINAL PROLAPSE PROCEDURE USING A CAPIO SLIM DEVICE, THE DEVICE MISFIRED RESULTING TO THE CAGE TO FAILING TO CATCH THE NEEDLE. THE PHYSICIAN HAD TO THROW MULTIPLE ATTEMPTS TO CATCH THE SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE, WITH EXTENDED OPERATING TIME REPORTED. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21887504 ↗
• MalfunctionApr 3, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT DURING A MESH PLACEMENT PROCEDURE USING A CAPIO SLIM DEVICE, THE CARRIER GOT STUCK IN THE LAST POSITION AND FAILED TO MOVE TO THE FRONT POSITION AND EJECT THE NEEDLE. THE ORIGINAL DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769898 ↗
• MalfunctionFeb 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A TRANSVAGINAL MESH PROCEDURE, THE DART DETACHED FROM THE SUTURE AND FELL INSIDE THE PATIENT. AN ATTEMPT TO RETRIEVE THE DART WAS MADE, BUT IT COULD NOT BE REMOVED. ANOTHER CAPIO SLIM DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND NO COMPLICATIONS WERE REPORTED FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21404647 ↗
• MalfunctionJan 17, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO DEVICE, THE DART DETACHED FROM THE SUTURE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO SLIM DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21182710 ↗
• MalfunctionJan 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT SUSPENSION USING A CAPIO SLIM DEVICE, WHEN THE PHYSICIAN THREW THE SUTURE, THE DART DETACHED. AN X-RAY WAS PERFORMED TO SEE IF DART DETACHED INSIDE THE PATIENT; HOWEVER, IT WAS NOT VISIBLE ON X-RAY. THE PHYSICIAN ASSUMED THAT THE DART GOT CAUGHT IN THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

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

  MAUDE report 21173300 ↗
• MalfunctionDec 13, 2024Retraction Problem; Use of Device Problem; Retraction Problem; Use of Device Problem

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT FIXATION VAULT SUSPENSION PROCEDURE USING A CAPIO SLIM DEVICE, THE CARRIER FAILED TO RETRACT FOLLOWING A SINGLE DEPLOYMENT BY THE PHYSICIAN. ADDITIONALLY, THE PHYSICIAN DID NOT APPLY TENSION TO THE SUTURE AGAINST THE HANDLE WHILE THROWING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924089 ↗