Capio CL M0068311350Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729516545), received between Jul 30, 2019 and Jul 31, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Feb 12, 2018Terminated

   Potential for Capio sutures to break and /or detach.

   Z-1618-2018 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2019Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO CL DEVICE WAS USED DURING A SUBURETHRAL SLING PLACEMENT WITH ANTERIOR AND POSTERIOR REPAIR PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS CORRECTLY FIRED ONCE. HOWEVER, WHEN DEPLOYING THE CAPIO DEVICE ON THE PATIENT'S LEFT SIDE, THE DART DETACHED FROM THE SUTURE. REPORTEDLY, THERE WERE TWO DARTS THAT DETACHED FROM THE SUTURES. AN X-RAY WAS SUBSEQUENTLY PERFORMED AND THE RADIOLOGIST COULD NOT LOCATE ANY DART INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO CL 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 GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8848465 ↗
• MalfunctionJul 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO CL DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DART DETACHED FROM THE SUTURE INSIDE THE PATIENT. A SECOND CAPIO SUTURE WAS OPENED AND THE DART DID NOT DEPLOY AND IT ALSO DETACHED FROM THE SUTURE. REPORTEDLY, AN X-RAY WAS PERFORMED AND THE DART COULD NOT BE LOCATED INSIDE THE PATIENT. THEREFORE, IT WAS CONCLUDED THAT THE DARTS WERE STILL STUCK IN THE DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO CL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8843880 ↗