Capio M0068312320Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 08714729753087), received between Dec 8, 2016 and Nov 25, 2025 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 reports).

1 FDA recall record name this device's identifier.

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. Feb 12, 2018Terminated

   Potential for Capio sutures to break and /or detach.

   Z-1620-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BULLET WAS NOT SEATED IN THE DEVICE AFTER DEPLOYMENT. THE BULLET CANNOT BE LOCATED UPON INSPECTION AND IS SUSPECTED TO BE LODGED WITHIN THE DEVICE SHAFT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645577 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE CAPIO SUTURING DEVICE FIRED CORRECTLY BUT THE BULLET COULD NOT BE RETRIEVED FROM THE DEVICE. A SEARCH WAS CONDUCTED AS PART OF THE TROUBLESHOOTING PROCESS, AND THE BULLET MAY HAVE LODGED WITHIN THE DEVICE; HOWEVER, THE BULLET COULD NOT BE LOCATED. THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23451599 ↗
• MalfunctionNov 18, 2020Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPIO PACKAGED, PC DEVICES WERE USED DURING A SACROSPINOUS LIGAMENT FIXATION PERFORMED ON (B)(6) 2020 TO TREAT PROLAPSE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD A DIFFICULTY LOADING THE SUTURE INTO THE CARRIER. ONCE THE SUTURE WAS LOADED AND THE DEVICE WAS DEPLOYED ON THE PATIENT'S RIGHT SIDE, THE DART DETACHED FROM THE SUTURE BUT REMAINED LOOSE IN THE CAPIO DEVICE. THE DART DID NOT FALL OFF INTO THE PATIENT. A SECOND DEVICE WAS OPENED BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO PACKAGED, PC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10858637 ↗
• MalfunctionNov 18, 2020Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility; Use of Device Problem; Detachment of Device or Device Component; Device-Device Incompatibility

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO CAPIO PACKAGED, PC DEVICES WERE USED DURING A SACROSPINOUS LIGAMENT FIXATION PERFORMED ON (B)(6) 2020 TO TREAT PROLAPSE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD A DIFFICULTY LOADING THE SUTURE INTO THE CARRIER. ONCE THE SUTURE WAS LOADED AND THE DEVICE WAS DEPLOYED ON THE PATIENT'S RIGHT SIDE, THE DART DETACHED FROM THE SUTURE, BUT REMAINED LOOSE IN THE CAPIO DEVICE. THE DART DID NOT FALL OFF INTO THE PATIENT. A SECOND DEVICE WAS OPENED, BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO PACKAGED, PC DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10858608 ↗
• MalfunctionJun 11, 2020Retraction Problem; Use of Device Problem; Retraction Problem; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO PACKAGED, PC DEVICE WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY IN RETRACTING THE CAPIO CARRIER AND CAPTURING THE DART. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10141699 ↗
• MalfunctionJun 10, 2020Misfire; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO PACKAGED, PC DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE MISFIRED WHEN THE SUTURE WAS LOADED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10137745 ↗
• MalfunctionJun 2, 2020Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO PACKAGED, PC DEVICE WAS USED DURING AN ANTERIOR AND POSTERIOR REPAIR WITH ACELL, SPHINCTER REPAIR USING ACELL CYTAL WOUND MATRIX 6-LAYER MESH PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY WITH CATCHING THE DART IN THE CAGE. REPORTEDLY, HE LOADED AND DEPLOYED THE SUTURE A FEW TIMES BEFORE THE SUTURE WAS PASSED THROUGH THE LIGAMENT. IT WAS BELIEVED THAT THIS WAS DUE TO NOT THOROUGHLY RINSING THE CAPIO DEVICE IN BETWEEN THROWS INTO THE LIGAMENT. SUBSEQUENTLY, THE DART DETACHED FROM THE SUTURE ON THE PATIENT'S RIGHT SIDE AND WAS NOT RETRIEVED. THERE WAS NO ANY ATTEMPT TO REMOVE THE DART FROM THE PATIENT. THE PHYSICIAN BELIEVED THAT THE DART MIGHT HAVE DETACHED FROM THE SUTURE AFTER DEPLOYMENT, WHILE THE DEVICE WAS BEING PULLED FROM THE SACROSPINOUS LIGAMENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION RECEIVED ON AUGUST 18, 2020: APPROXIMATELY 3MM DART DETACHED F

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10112106 ↗
• InjuryMay 7, 2020Break; Therapeutic or Diagnostic Output Failure

  BOSTON SCIENTIFIC CAPIO DEVICE AND ASSOCIATED SUTURE MALFUNCTIONED, CAUSING THE "BULLET" TO BREAK AND A SMALL PIECE (APPROX 3 MM) BROKE OFF. UNABLE TO VISUALIZE ON XRAY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10038259 ↗
• MalfunctionMar 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO PACKAGED, PC DEVICE WAS USED DURING A TOTAL HYSTERECTOMY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DART DETACHED ON THE PATIENT'S LEFT SIDE AND WAS NOTICED AFTER THE CAPIO DEVICE WAS DEPLOYED. REPORTEDLY, THE DETACHED DART WAS STUCK INSIDE THE CAPIO DEVICE. FURTHERMORE, A PORTABLE X-RAY WAS USED TO CONFIRM THAT THE DETACHED PIECE WAS NOT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO PACKAGED, PC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9809258 ↗
• MalfunctionSep 25, 2019Misfire; Device-Device Incompatibility; Misfire; Device-Device Incompatibility

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO PC DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPAINANT, DURING THE PROCEDURE, THE DEVICE MISFIRED AND DID NOT LOAD PROPERLY. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9119792 ↗
• MalfunctionApr 30, 2018Detachment Of Device Component

  CAPIO INSTRUMENT FAILURE: TIP RETAINED DURING ANTERIOR REPAIR.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7475180 ↗
• InjuryApr 3, 2018Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO DEVICE WAS USED DURING A VAGINAL HYSTERECTOMY WITH ANTERIOR REPAIR PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, UPON RETRACTING THE CAPIO, THE CARRIER TIP DETACHED. THE PHYSICIAN THEN PERFORMED AN X-RAY BUT HE DID NOT FOUND THE CARRIER TIP. IT WAS REPORTED THAT THE TIP WAS LEFT INSIDE THE PATIENT AND HE WAS NOT ABLE TO RETRIEVE IT, SUBSEQUENTLY. THE PROCEDURE WAS COMPLETED WITH THE CAPIO DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7391316 ↗
• InjuryJan 11, 2017Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO DEVICE WAS USED DURING A MESH PLACEMENT PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE SUTURING THE SACROSPINOUS LIGAMENT, THE CAPIO CARRIER BROKE OFF THE DEVICE. THE DETACHED PIECE WAS "UNRETRIEVABLE" AND LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6243968 ↗
• InjuryDec 8, 2016Detachment Of Device Component; Detachment Of Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO¿ WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE DETACHED FROM THE SUTURE INSIDE THE PATIENT. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE; A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6155282 ↗