Capio SLIMRecalls & reported problems across all models

We found 2 models of Capio SLIM by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 478 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2016 and Jul 8, 2026 — classified as 67 injuries, 411 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (152 reports).

4 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Capio SLIM recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

3. Feb 12, 2018Terminated

   Potential for Capio sutures to break and /or detach.

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

4. Feb 12, 2018Terminated

   Potential for Capio sutures to break and /or detach.

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

Most reported Capio SLIM problems

Capio SLIM models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Capio SLIM M0068318260

  Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
  3 recalls282 reports
• Capio SLIM M0068318250

  Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
  1 recall196 reports

Recent Capio SLIM adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 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 ↗
• 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 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 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 ↗
• 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 ↗

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