Trek TKL1006Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741201417), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2024Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A COMPUTER TOMOGRAPHY GUIDED LESION BIOPSY PROCEDURE, BONE IS SEVERELY SCLEROTIC AND EXTREMELY DIFFICULT TO PENETRATE. IT WAS FURTHER REPORTED THAT THE COAXIAL BIOPSY NEEDLE WAS ALLEGEDLY LOADED ONTO THE DRILL, AND EXTREME DIFFICULTY WAS ENCOUNTERED IN ADVANCING THE NEEDLE AND APPROXIMATELY 2 CM DISTAL PORTION OF THE NEEDLE WAS SHEARED OFF OF THE BIOPSY NEEDLE. REPORTEDLY, THE SEPARATED FRAGMENT WAS VISUALIZED TO BE WITHIN THE SEVERELY SCLEROTIC LESION AND A NEW COAXIAL NEEDLE WAS ADVANCED CAREFULLY OVER THE FRAGMENTED PORTION AND IT WAS CAPTURED WITHIN THE COAXIAL NEEDLE. HOWEVER, THE COAXIAL NEEDLE WAS THEN REMOVED WITH RETRIEVAL OF MOST OF THE FRACTURED SEGMENT EXCEPT 2 TINY FRAGMENTS WITHIN THE SCLEROTIC LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 20531527 ↗