Trek TKDRIVERRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741201356), received between Jun 16, 2023 and Jan 5, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Break; Mechanical Jam; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING THROUGH THE TREK POWER DRIVER. DURING THE PROCEDURE, IT WAS FOUND THAT THE DRIVER WAS PAUSING PERIODICALLY DURING CASES. FURTHER IT WAS REPORTED THAT THE DRIVER ALLEGEDLY FAILED TO STOP WHEN THE TRIGGER WAS RELEASED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955397 ↗
• MalfunctionJan 5, 2026Mechanical Jam; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT BIOPSY PROCEDURE USING THROUGH THE TREK POWER DRIVER. DURING THE PROCEDURE, IT WAS FOUND THAT THE DRIVER WAS PAUSING PERIODICALLY DURING CASES. FURTHER IT WAS REPORTED THAT THE DRIVER ALLEGEDLY FAILED TO STOP WHEN THE TRIGGER WAS RELEASED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955394 ↗
• MalfunctionSep 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A PATIENT WAS PREPPED FOR A BIOPSY PROCEDURE USING THE TREK POWER DRIVER. PRIOR TO THIS PROCEDURE, THE LOT NUMBER AND MANUFACTURE DATE DID NOT MATCH BETWEEN THE DRIVER AND THE PACKAGING. THERE WAS NO CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049022 ↗
• MalfunctionSep 15, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TREK DRIVER. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE, THE LABELS DO NOT MATCH. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23048336 ↗
• MalfunctionDec 14, 2023Device Markings/Labelling Problem; Unclear Information; Device Markings/Labelling Problem; Unclear Information

  IT WAS REPORTED THAT DURING A BONE MARROW BIOPSY PROCEDURE, THERE WAS ALLEGEDLY HAD TROUBLE IN IDENTIFYING THE SERIAL NUMBER ON THE LABEL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18325670 ↗
• MalfunctionJul 18, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A BONE BIOPSY PROCEDURE, DEVICE ALLEGEDLY HAD MECHANICAL JAM. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339977 ↗
• MalfunctionJun 16, 2023Accessory Incompatible; Material Twisted/Bent; Unintended Movement; Accessory Incompatible; Material Twisted/Bent; Unintended Movement

  IT WAS REPORTED THAT THE POWERED BONE BIOPSY DRIVER ALLEGEDLY APPEARED TO BE WOBBLING. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY BENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17141850 ↗