TELEFLEX IPN056766Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 14026704735317), received between Jun 14, 2022 and Jul 15, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "THE CAPIO FORCEPS SEVERED THE NEEDLE WHILE PASSING THROUGH THE SACROSPINOUS LIGAMENT. NEEDLE REMAINED IN PLACE IN THE PATIENT'S PELVIS, UNABLE TO BE REMOVED.".

  Patient problems: Foreign Body In Patient

  MAUDE report 22512431 ↗
• MalfunctionFeb 11, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT "DURING A RICHTER HYSTERECTOMY, THE SUTURE WIRE DETACHED FROM THE DART. THE DART WAS NOT FOUND". NO PATIENT HARM OR INJURY. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS NOT RETURNED OUR REQUESTS FOR ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356550 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "THE CAPIO SLIM DEVICE WAS SUTURED AND FIRED. AFTER THAT, THE THREAD BREAKS DURING FIXATION. THE THREAD WAS REPLACED WITH A NEW ONE, BUT THE SAME REPRODUCIBILITY OCCURS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER LOT. THE TWO BROKEN THREADS WERE COLLECTED". NO REPORT OF PATIENT HARM OR INJURY. SEE ASSOCIATED MDR #3004365956-2024-00067.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088380 ↗
• MalfunctionAug 28, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT "THE CAPIO SLIM DEVICE WAS SUTURED AND FIRED. AFTER THAT, THE THREAD BREAKS DURING FIXATION. THE THREAD WAS REPLACED WITH A NEW ONE, BUT THE SAME REPRODUCIBILITY OCCURS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER LOT. THE TWO BROKEN THREADS WERE COLLECTED". NO REPORT OF PATIENT HARM OR INJURY. SEE ASSOCIATED MDR #3004365956-2024-00061.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20088306 ↗
• MalfunctionAug 21, 2024Material Separation; Material Separation

  IT WAS REPORTED "WE USED A CAPIO SLIM ON TUESDAY JUST TO UPDATE THAT NEEDLE, IT SNAPPED OFF DURING PROCEDURE". ADDITIONAL INFORMATION STATES THAT THE DEVICE WAS REPLACED. NO PATIENT INJURY OR CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20013904 ↗
• MalfunctionAug 13, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED "THE CAPIOSLIM DEVICE WAS SUTURED AND FIRED. AFTER THAT, THE THREAD BREAKS DURING FIXATION. THE THREAD WAS REPLACED WITH A NEW ONE, BUT THE SAME REPRODUCIBILITY OCCURS. AN INVESTIGATION WAS REQUESTED TO DETERMINE THE CAUSE OF THE PROBLEM. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER LOT. THE TWO BROKEN THREADS WERE COLLECTED, AND AN ANALYSIS WAS REQUESTED".

  Patient problems: Insufficient Information

  MAUDE report 19975452 ↗
• MalfunctionApr 1, 2024Break; Break

  IT WAS REPORTED THAT "THE THREAD BREAKS DURING FIXATION. THE THREAD WAS REPLACED WITH A NEW ONE, BUT THE SAME REPRODUCIBILITY OCCURS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER LOT". NO PATIENT HARM OR INJURY. SEE ASSOCIATED MDR #3004365956-2024-00032.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19012030 ↗
• MalfunctionMar 20, 2024Break; Break

  IT WAS REPORTED THAT "THE THREAD BREAKS DURING FIXATION. THE THREAD WAS REPLACED WITH A NEW ONE, BUT THE SAME REPRODUCIBILITY OCCURS. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS USING ANOTHER LOT". NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18942254 ↗
• MalfunctionJun 14, 2022Material Separation; Material Separation

  TAPERCUT CAME OFF THE SUTURE DURING PLACEMENT IN SACROSPINOUS LIGAMENT. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14686298 ↗