Capio M0068311250Recalls & reported problems

Summary

The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 08714729753070), received between Nov 17, 2016 and Aug 31, 2026 — classified as 28 injuries, 49 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (42 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-1619-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 31, 2026Detachment of Device or Device Component

  It was reported to Boston Scientific Corporation that, during the use of a Capio device, the bullet needle detached from the suture when the device was removed from the cavity during the first pass through the ligament. An attempt was made to recover the needle, but it could not be found because it was too small to locate. The procedure was completed using the original Capio device. There were no patient complications reported.

  Patient problems: Foreign Body In Patient

  MAUDE report 50515512 ↗
• MalfunctionMay 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO DEVICE, 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 SECOND OF TWO DEVICES USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128181 ↗
• MalfunctionMar 2, 2026Misfire

  IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED USING A CAPIO SLIM DEVICE, THE DEVICE MISFIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483077 ↗
• MalfunctionJan 14, 2026Unsealed Device Packaging

  IT WAS REPORTED THAT DURING PREPARATION, WHEN THE TECHNICIAN OPENED THE CAPIO DEVICE, IT WAS DISCOVERED THAT IT WAS NOT SEALED. THE CAPIO DEVICE SLIPPED FROM THE PACKAGING, FELL TO THE FLOOR, AND BECAME UNUSABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO SLIM AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24073127 ↗
• MalfunctionJul 3, 2025Detachment of Device or Device Component; 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. ANOTHER CAPIO SLIM DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22401504 ↗
• MalfunctionApr 4, 2025Misfire; Detachment of Device or Device Component; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO DEVICE, THE DEVICE MISFIRED WHILE ATTEMPTING TO PLACE THE SUTURE IN THE LIGAMENT. AN ATTEMPT WAS MADE TO RETRIEVE THE SUTURE, BUT THE DART DETACHED FROM THE SUTURE. GIVEN THE SIZE OF THE SUTURE, THE PHYSICIAN DECIDED TO RETAIN THE SUTURE DART WITHIN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21773166 ↗
• MalfunctionOct 29, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A PROCEDURE USING A CAPIO DEVICE, THE DART DETACHED. THE DART FELL INSIDE THE PATIENT AND THE PHYSICIAN STATED THAT IT WOULD HAVE MORE RISK IF THE DETACHED DART WOULD NOT BE RETRIEVED AND REMAINED INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20558981 ↗
• MalfunctionOct 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO SLIM DEVICE, THE DART DETACHED AND FELL OFF INSIDE THE PATIENT. AN X-RAY WAS PERFORMED TO SEE WHERE THE BULLET WENT; HOWEVER, IT WAS NOT LOCATED AND THE PHYSICIAN DECIDED TO LEAVE IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20467317 ↗
• MalfunctionOct 10, 2024Use of Device Problem; Detachment of Device or Device Component; Difficult to Open or Close; Use of Device Problem; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RETROPUBIC MID-URETHRAL SLING PROCEDURE. DURING THE SAME SURGERY, SACROSPINOUS HYESTEROPEXY, ANTERIOR COLPORRHAPHY, AND POSTERIOR COLPORRHAPHY PROCEDURES WERE ALSO PERFORMED. IT WAS NOTED THAT THE BULLET BROKE OFF THE SUTURE AND GOT STUCK INTO THE METAL INSIDE THE DEVICE. ----ADDITIONAL INFORMATION RECEIVED ON OCTOBER 22, 2024. IT WAS LATER CLARIFIED THAT THE BULLET DID NOT BREAK OFF THE SUTURE. DURING THE PROCEDURE, THE SUTURE WAS NOT CATCHING THE LIGAMENT, AND THE DART WAS NOT CAUGHT IN THE CAGE. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS REPORTING CRITERIA FOR THE DEVICE IN QUESTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20419082 ↗
• MalfunctionSep 19, 2024

  UPON FIRING BULLET AND AFTER PULLING SUTURE BACK, THE BULLET BROKE OFF OF SUTURE AND STUCK INTO METAL INSIDE OF DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 20256677 ↗
• MalfunctionJul 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A VAULT SUSPENSION PROCEDURE USING A CAPIO SUTURING DEVICE, THE CAPIO CARRIER EXTENDED WHEN THE DEVICE WAS ACTUATED; HOWEVER, THE DART WAS LEFT IN THE TISSUE OF THE PATIENT. THIS WAS EVENTUALLY VIEWED ON AN X-RAY. A NON-BOSTON SCIENTIFIC SUTURE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19784257 ↗
• MalfunctionJul 4, 2024Use 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, THE DEVICE WOULD NOT CAPTURE THE SUTURE AND THE SUTURE BROKE WHERE IT CONNECTS TO THE DART. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO SLIM DEVICE, AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19675022 ↗
• MalfunctionJul 3, 2024Use 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 TWO CAPIO DEVICES, IT WOULD NOT CAPTURE THE SUTURE AND THE HEADS BROKE OFF THE SUTURE LINE. THERE WAS NO INFORMATION ON WHAT COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2024-38799 FOR THE FIRST CAPIO DEVICE, AND 2124215-2024-38800 FOR THE SECOND CAPIO DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669333 ↗
• MalfunctionJul 3, 2024Use 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 TWO CAPIO DEVICES, IT WOULD NOT CAPTURE THE SUTURE AND THE HEADS BROKE OFF THE SUTURE LINE. THERE WAS NO INFORMATION ON WHAT COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2024-38799 FOR THE FIRST CAPIO DEVICE, AND 2124215-2024-38800 FOR THE SECOND CAPIO DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669241 ↗
• MalfunctionMay 15, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CAPIO DEVICE WAS USED DURING A SACROSPINOUS FIXATION PROCEDURE. DURING THE PROCEDURE, THE DEVICE WOULD NOT CAPTURE THE SUTURE INTO THE CAGE AND THE DART WAS DETACHED FROM THE SUTURE DURING DEPLOYMENT. THE DETACHED PIECE DID NOT FALL OFF INTO THE PATIENT. ANOTHER CAPIO DEVICE WAS USED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19318980 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT A CAPIO DEVICE WAS USED DURING A SACROSPINOUS FIXATION PROCEDURE. DURING THE PROCEDURE, THE DEVICE WOULD NOT CAPTURE THE SUTURE INTO THE CAGE AND THE DART WAS DETACHED FROM THE SUTURE DURING DEPLOYMENT. THE DETACHED PIECE DID NOT FALL OFF INTO THE PATIENT. ANOTHER CAPIO DEVICE WAS USED AND SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310368 ↗
• MalfunctionApr 3, 2024Use of Device Problem; Failure to Align; Misfire; Use of Device Problem; Failure to Align; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO DEVICE WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE SUTURE WAS NOT ALIGNING AND WAS MISFIRING. IT WAS UNKNOWN WHAT HAD COMPLETED THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19038364 ↗
• MalfunctionMar 21, 2024Retraction Problem; Retraction Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO DEVICE WAS USED DURING A PROCEDURE PERFORMED. DURING THE PROCEDURE, THE BULLET STUCK WITHIN CAPIO. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18956150 ↗
• MalfunctionDec 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE SUTURE REMAINED IN THE CAPIO DEVICE. THE NURSE PARTIALLY OPENED THE LOWER METAL HOUSING FOR THE BULLET RETRIEVAL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410391 ↗
• MalfunctionOct 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO SLIM WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, WHEN THE CAPIO DEVICE WAS PULLED OUT OF THE PATIENT, IT WAS DEFINED THAT THE DART HAD DETACHED FROM THE SUTURE. TO ENSURE NOTHING WAS LEFT INSIDE THE PATIENT, AN X-RAY WAS PERFORMED. THE CAPIO DEVICE WAS EXAMINED, AND A KNIFE AND A HYPODERMIC NEEDLE WERE USED TO FIND THE NEEDLE IN THE HEAD (BOTTOM) PART OF THE DEVICE. ALTHOUGH THERE WAS A DELAY IN THE SURGERY AND REQUIRED MORE TIME UNDER ANESTHESIA, THERE IS NO INFORMATION AS TO HOW THE PROCEDURE WAS COMPLETED. X-RAYS WERE NEEDED TO ENSURE NO NEEDLE OR DART WAS LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951066 ↗
• MalfunctionJul 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO OPC DEVICE WAS USED DURING A SACROSPINOUS LIGAMENT FIXATION AND VAGINAL VAULT SUSPENSION PROCEDURE PERFORMED ON (B)(6) 2023, FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE. DURING THE PROCEDURE, WHEN THE PHYSICIAN APPLIED TENSION TO THE SUTURE, THE SUTURE BROKE IN HALF. THE BREAK WAS LOCATED AT THE CENTER OF THE TOTAL LENGTH, OR HALFWAY POINT, OF THE SUTURE. BOTH ENDS OF THE BROKEN SUTURE WERE REMOVED, AND NOTHING WAS LEFT INSIDE THE PATIENT. THE SUTURE WITH THE ATTACHED DART WAS OUTSIDE THE PATIENT WHEN THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE ALONG WITH THE NEW SUTURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268224 ↗
• MalfunctionMar 13, 2023Break; Failure to Align

  REPORTED THAT WHEN TRYING TO PASS THE SUTURE THE ALIGNMENT WAS OFF, SO IT BROKE THE SUTURE.

  Patient problems: Insufficient Information

  MAUDE report 16528729 ↗
• MalfunctionFeb 13, 2023Detachment of Device or Device Component; Difficult to Open or Close; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO DEVICE WAS USED DURING A SACROSPINOUS LIGAMENT VAULT SUSPENSION PROCEDURE PERFORMED ON (B)(6) 2022. DURING PROCEDURE, THE DART GOT STUCK IN THE CAPIO GROOVE AND DETACHED FROM THE SUTURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368882 ↗
• MalfunctionOct 26, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO OPC DEVICE WAS USED DURING A COLPOPEXY PROCEDURE PERFORMED ON (B)(6), 2022, FOR THE TREATMENT OF PROLAPSE. DURING THE PROCEDURE, THE FIRST TIME THE DEVICE WAS DEPLOYED ON THE PATIENT'S RIGHT SIDE, THE DART DETACHED FROM THE SUTURE AND WAS LEFT INSIDE THE PATIENT'S VAGINAL CANAL. AN X-RAY WAS TAKEN POST PROCEDURE, BUT THE DART WAS NOT LOCATED. THE PROCEDURE WAS COMPLETED WITH A CAPIO SLIM DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674656 ↗
• MalfunctionFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO DEVICE WAS USED DURING A PROCEDURE ON (B)(6) 2021. DURING THE PROCEDURE, THE SUTURE DART BROKE OFF. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DART AND IT REMAINS INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13581305 ↗