Capio SLIM M0068318260Recalls & reported problems

Summary

The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 08714729842804), received between Nov 20, 2016 and Jul 8, 2026 — classified as 44 injuries, 238 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (85 reports).

3 FDA recall records 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-2451-2024 · Root cause: Process change control · FDA record ↗

2. Feb 12, 2018Terminated

   Potential for Capio sutures to break and /or detach.

   Z-1617-2018 · Root cause: Device Design · FDA record ↗

3. Feb 12, 2018Terminated

   Potential for Capio sutures to break and /or detach.

   Z-1616-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 282 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2026Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT, DURING USE OF A CAPIO SLIM DEVICE IN A PROLAPSE REPAIR PROCEDURE, THE DEVICE MISFIRED AND COULD NOT COMPLETE THE SUTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25751106 ↗
• MalfunctionJun 25, 2026Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT CAPIO SLIM WAS USED ON A SACROSPINOUS LIGAMENT REPAIR PROCEDURE. DURING THE PROCEDURE, TWO DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT FULLY RECOVERED. 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 25630307 ↗
• MalfunctionJun 12, 2026

  TWO CAPIO SLIM DEVICES FOR SACROSPINAL LIGAMENT FIXATION WERE TOO STIFF AND NOT RETRIEVING BULLET/ FIRING PROPERLY. THIRD DEVICE WAS OPENED AND WORKED FINE. NO HARM TO THE PATIENT. MALFUNCTIONED DEVICES WERE TAKEN OFF THE FIELD. MANUFACTURER RESPONSE FOR INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, TRANSVAGINAL REPAIR OF PELVIC OR, CAPIO SLIM (PER SITE REPORTER).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484965 ↗
• MalfunctionJun 3, 2026

  CAPIO DEVICE NOTED BY SURGEON TO BE MISFIRING. NO FURTHER DESCRIPTION FOUND IN OPERATIVE NOTE. MANUFACTURER RESPONSE FOR INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC, TRANSVAGINAL REPAIR OF PELVIC OR, CAPIO SLIM (PER SITE REPORTER). NOT KNOWN AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25374125 ↗
• InjuryMay 15, 2026Misfire

  IT WAS REPORTED THAT DURING SACROSPINOUS LIGAMENT FIXATION PROCEDURE, FIVE CAPIO SLIM DEVICES WERE USED FOR PELVIC ORGAN PROLAPSE. DURING THE PROCEDURE, THE DEVICES DID NOT FIRE PROPERLY. HOSPITAL ADMISSION WAS REQUIRED FOR THE PATIENT FOR ADDITIONAL SURGICAL INTERVENTION. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF FIVE DEVICES USED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194154 ↗
• MalfunctionApr 9, 2026Use of Device Problem; Detachment of Device or Device Component; Difficult to Open or Close

  IT WAS REPORTED THAT A CAPIO SLIM DEVICE WAS USED DURING A VAULT SUSPENSION PROCEDURE ON (B)(6) 2026. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC SUTURE DID NOT PENETRATE THE INTENDED LIGAMENT ON THE PATIENT'S RIGHT SIDE. THE SURGEON REPLACED THE SUTURE AND ATTEMPTED TO RETHROW IT. AT THAT TIME, THE SURGEON OBSERVED THAT THE DART WAS NO LONGER ATTACHED TO THE END OF THE SUTURE. THE DEVICE CAGE WAS OPENED BY BENDING THE METAL HOUSING, AT WHICH POINT THE DETACHED DART WAS LOCATED WITHIN THE DEVICE WITH A VERY SMALL PORTION OF SUTURE REMAINING ATTACHED (LESS THAN 1 CM). THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO SLIM WITH A DIFFERENT SUTURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24834991 ↗
• MalfunctionMar 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO SLIM DEVICE, THE BULLET DID NOT ENGAGE WITH THE RECEIVING MECHANISM AND DETACHED FROM THE SUTURE, RESULTING IN THE BULLET BEING RETAINED IN THE PATIENT. THE SUTURE BROKE ON THE RIGHT SIDE OF THE PATIENT RIGHT AT THE DART. ATTEMPTS WERE MADE TO RETRIEVE THE BULLET; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ANOTHER SUTURE WITH THE SAME CAPIO DEVICE, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24651549 ↗
• MalfunctionMar 12, 2026Misfire

  IT WAS REPORTED THAT DURING THE SACROSPINOUS LIGAMENT PROCEDURE, TWO CAPIO SLIM DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579433 ↗
• MalfunctionMar 12, 2026Misfire

  IT WAS REPORTED THAT DURING THE SACROSPINOUS LIGAMENT PROCEDURE, TWO CAPIO SLIM DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO DEVICES USED DURING THE SAME PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24579407 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE BULLET GOT STUCK IN THE DEVICE, REQUIRING THE USE OF INSTRUMENTS TO PRY OPEN THE DEVICE TO RETRIEVE THE SUTURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207331 ↗
• MalfunctionJan 28, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE BULLET GOT STUCK IN THE DEVICE, REQUIRING THE USE OF INSTRUMENTS TO PRY OPEN THE DEVICE TO RETRIEVE THE SUTURE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24205646 ↗
• MalfunctionJan 28, 2026Retraction Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A PROCEDURE USING A CAPIO SLIM DEVICE, THE HOOK DID NOT FIT INTO THE HOLE, AND THE HANDLE GOT STUCK AND FAILED TO MOVE SMOOTHLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200247 ↗
• MalfunctionJan 9, 2026Retraction Problem

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO SLIM DEVICE, THE CARRIER FAILED TO RETRACT. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO THROW THE SUTURE USING A CAPIO DEVICE, THE PHYSICIAN DECIDED NOT TO USE THE CAPIO DEVICE TO PLACE THE FINAL SUTURE AND INSTEAD MANUALLY LOCATED THE SACROSPINOUS LIGAMENT AND PERFORMED TRADITIONAL (NON-DEVICE) SUTURING TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24030666 ↗
• MalfunctionJan 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE FOR VAGINAL PROLAPSE USING A CAPIO SLIM, THE DEVICE WOULD NOT CAPTURE THE NEEDLE. A SECOND CAPIO SLIM WAS USED BUT IT ALSO FAILED TO CAPTURE THE NEEDLE. THE PROCEDURE WAS THEN CANCELLED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN. 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 24028043 ↗
• MalfunctionJan 9, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE FOR VAGINAL PROLAPSE USING A CAPIO SLIM, THE DEVICE WOULD NOT CAPTURE THE NEEDLE. A SECOND CAPIO SLIM WAS USED BUT IT ALSO FAILED TO CAPTURE THE NEEDLE. THE PROCEDURE WAS THEN CANCELLED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION STATUS UNKNOWN. 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 24028029 ↗
• MalfunctionDec 22, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE 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 23865926 ↗
• MalfunctionDec 19, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT UPON OPENING THE PACKAGING DURING PREPARATION, THERE WAS A HOLE OBSERVED IN THE LAST LAYER OF THE PACKAGING, COMPROMISING THE STERILITY OF THE PRODUCT. THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856765 ↗
• MalfunctionDec 9, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE SACROSPINOUS LIGAMENT PROCEDURE, TWO CAPIO SLIM DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-89001 FOR THE FIRST CAPIO SLIM DEVICE, AND 2124215-2025-89003 FOR THE SECOND CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759647 ↗
• MalfunctionDec 9, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE SACROSPINOUS LIGAMENT PROCEDURE, TWO CAPIO SLIM DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING ANOTHER CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-89001 FOR THE FIRST CAPIO SLIM DEVICE, AND 2124215-2025-89003 FOR THE SECOND CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759645 ↗
• MalfunctionOct 31, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE PROCEDURE, TWO CAPIO DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING A THIRD CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-77408 FOR THE FIRST CAPIO SLIM DEVICE, AND FOR THE SECOND CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441703 ↗
• MalfunctionOct 31, 2025Misfire; Misfire

  IT WAS REPORTED THAT DURING THE PROCEDURE, TWO CAPIO DEVICES MISFIRED. THE PROCEDURE WAS COMPLETED USING A THIRD CAPIO DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-77408 FOR THE FIRST CAPIO SLIM DEVICE, AND 2124215-2025-77421 FOR THE SECOND CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23441696 ↗
• MalfunctionSep 16, 2025Misfire; Misfire

  IT WAS REPORTED THAT, DURING A SACROSPINOUS LIGAMENT FIXATION PROCEDURE USING A CAPIO SLIM, THE DEVICE MISFIRED. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23062701 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A SACROSPINOUS FIXATION PROCEDURE, THE DEVICE WAS NOT WORKING PROPERLY. THE REPORTED FAILURE MODE SUGGESTS BREAK/FRACTURE, THOUGH IT IS UNCERTAIN WHETHER THERE WAS A COMPLETE DETACHMENT. THE REPORTED EVENT MOST LIKELY INDICATES THAT THE CARRIER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING A PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-59160 FOR THE SECOND CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937896 ↗
• MalfunctionSep 2, 2025Break; Break

  IT WAS REPORTED THAT DURING A SACROSPINOUS FIXATION PROCEDURE, THE DEVICE WAS NOT WORKING PROPERLY. THE REPORTED FAILURE MODE SUGGESTS BREAK/FRACTURE, THOUGH IT IS UNCERTAIN WHETHER THERE WAS A COMPLETE DETACHMENT. THE REPORTED EVENT MOST LIKELY INDICATES THAT THE CARRIER BROKE. NO PATIENT COMPLICATIONS WERE REPORTED. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE A PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 2124215-2025-59042 FOR THE FIRST CAPIO SLIM DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22937227 ↗
• MalfunctionAug 7, 2025Use 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

  IT WAS REPORTED THAT DURING AN ANTERIOR-POSTERIOR REPAIR AND SACROSPINOUS LIGAMENT SUSPENSION PROCEDURE USING A CAPIO SLIM DEVICE, THE DART DETACHED WHILE BEING LOADED INTO THE CAPIO CARRIER. 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 22738370 ↗