TELEFLEX IPN000885Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 54026704601696), received between Jul 20, 2023 and Aug 15, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT "THE NEEDLE DETACHED FROM SUTURE THREAD. THE SURGEON SUTURED THE TRANSPLANT USING MAXBRAID. AT THE END OF THE SUTURE, THE SURGEON PULLED THE MAXBRAID FROM THE NEEDLE ON HIS NEEDLE HOLDER AND THE NEEDLE DETACHED ITSELF FROM THE MAXBRAID. PATIENT IS MALE. THE SURGEON IS VERY EXPERIENCES IN SPORT MEDICINE, THAT REGULARLY DOES LAMINOPLASTY. NO CONSEQUENCES FOR THE PATIENT. PATIENT FINE. NO DELAY DUE TO THIS INCIDENT. NO MEDICAL PRE-EXISTING CONDITIONS THAT WOULD MIGHT HAVE CONTRIBUTED TO THIS INCIDENT. IT HAPPENED AT THE END OF THE PROCEDURE, SUTURE WAS COMPLETED, NO DEVICE REPLACED." SEE ASSOCIATED MDR #3004365956-2023-00053.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17551615 ↗
• MalfunctionJul 20, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT "THE NEEDLE DETACHED FROM SUTURE THREAD. THE SURGEON SUTURED THE TRANSPLANT USING MAXBRAID. AT THE END OF THE SUTURE, THE SURGEON PULLED THE MAXBRAID FROM THE NEEDLE ON HIS NEEDLE HOLDER AND THE NEEDLE DETACHED ITSELF FROM THE MAXBRAID." NO PATIENT HARM OR INJURY. THE PATIENT STATUS IS REPORTED AS "FINE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17360846 ↗