TELEFLEX IPN056765Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 14026704735300), received between Aug 29, 2023 and May 10, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024Material Separation; Material Separation

  IT WAS REPORTED " THE BULLET ON THE SUTURE CAME OFF THE END OF THE MONODEK SUTURE WHEN ATTEMPTING TO DEPLOY THE CAPIO SLIM DEVICE. IT WOULD NOT CAPTURE IN THE RECEIVING END OF THE DEVICE AND THE BULLET WAS SUBSEQUENTLY LEFT BEHIND IN THE PATIENT AS IT BECAME LODGED IN THE LIGMAENT. [THE USER] OPENED A SECOND MONODEK SUTURE AND A SECOND CAPIO SLIM DEVICE AND RESTARTED THE PROCEDURE AND COMPLETED SUCCESSFULLY". ADDITIONALLY IT WAS REPORTED "NO PATIENT COMPLICATIONS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288756 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED " CAPIO SUTURE MATERIAL WAS DEFECTIVE DURING THE SURGICAL PROCEDURE FOR PATIENT S. M. S. ACCORDING TO [ THE USER] , IT BROKE AT THE END WHERE IT FITS INTO THE CAPIO SLIM SUTURE CAPTURE DEVICE. THEREFORE, IT WAS NECESSARY TO OPEN AND USE ANOTHER THREAD TO COMPLETE THE PROCEDURE." ADDITIONAL INFOMATION ON THE PATIENT'S STATUSIS NOT AVAIBLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212828 ↗
• MalfunctionApr 30, 2024Break; Break

  IT WAS REPORTED " CAPIO SUTURE MATERIAL WAS DEFECTIVE DURING THE SURGICAL PROCEDURE FOR PATIENT (B)(6) . ACCORDING TO [ THE USER] , IT BROKE AT THE END WHERE IT FITS INTO THE CAPIO SLIM SUTURE CAPTURE DEVICE. THEREFORE, IT WAS NECESSARY TO OPEN AND USE ANOTHER THREAD TO COMPLETE THE PROCEDURE." ADDITIONAL INFOMATION ON THE PATIENT'S STATUSIS NOT AVAIBLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212683 ↗
• MalfunctionMar 20, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT "SUTURE FLICKED DURING SURGERY LEAVING THE TINY BEAD AT END OF SUTURE, LEAVING IT INSIDE PATIENT WHILE SURGEON PERFORMING ANTERIOR REPAIR. SURGEON ORDERED X-RAY TO ENSURE LOCATION OF PRODUCT INSIDE PATIENT". ADDITIONAL INFORMATION RECEIVED STATES THAT "THE 'DART' WAS SEEN ON X-RAY POST OP AND IS EMBEDDED IN THE PATIENT. SHE HAS NOT BEEN BROUGHT BACK INTO THE THEATRE TO REMOVE IT AS THEY BELIEVE IT WOULD CAUSE MORE DAMAGE". THE PATIENT'S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18940239 ↗
• MalfunctionAug 29, 2023Break; Break

  IT WAS REPORTED THAT "THEATRE NURSE REPORTED AN ARROW HEAD FROM A CAPIO SUTURE HAD BROKEN OFF INSIDE A PATIENT. IT WAS VISUALIZED ON X-RAY BUT IT WAS UNABLE TO BE REMOVED. THE CASE WAS SUCCESSFULLY COMPLETED USING ANOTHER SUTURE. UNFORTUNATELY, THE CAPIO DEVICE WAS DISPOSED OF. THEY ATTEMPTED MANUAL REMOVAL OF THE ARROWHEAD UNSUCCESSFULLY". AT THE TIME OF THIS REPORT THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, THE COMPLAINT FILE WILL BE UPDATED.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 17642016 ↗