Trek TKL1106Recalls & reported problems

Bard Peripheral Vascular, Inc. · Trek™ Bone Lesion Biopsy Kit, 11g x 6cm Introducer, 13g x 10.8cm Biopsy · Class 2

All models of Trek (8)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741201448), received between Apr 22, 2026 and Apr 22, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Component Missing” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Component Missing1

Patient problems

Unspecified Infection1

Recent adverse event reports

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

InjuryApr 22, 2026Component Missing
ON (B)(6) 2026, A PATIENT UNDERWENT A BONE BIOPSY PROCEDURE USING THE TREK BONE LESION KIT. DURING THE PROCEDURE, THE DEVICE PACKAGE DID NOT INCLUDE AN EJECTOR GUIDE. IT WAS FURTHER REPORTED THAT IT WILL READILY PUNCTURE THE OPERATOR'S SKIN AND CAUSE CONTAMINATION OR INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Unspecified Infection
MAUDE report 24950189 ↗

Device details

UDI-DI	`00801741201448`
Brand	Trek
Model	TKL1106
Company	Bard Peripheral Vascular, Inc.
Product code	KNW · INSTRUMENT, BIOPSY
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 6, 2022

Device type (GMDN): Vertebral bone biopsy procedure kit, single-use

A collection of sterile devices, equipment, and supplies used to obtain a bone specimen from the vertebrae of a patient (the bony segments of the spinal column) for histological analysis. It typically contains a metal cannula which can have various tip designs (e.g., bevelled, pyramidal, scoop-, or diamond-shaped) and stylet(s), a biopsy needle, an obturator, a needle holder, syringes, and connecting tube. The specimen can be used for the detection of cancer, infection, or other bone disorders. The device may also be used for vertebral infusion (e.g., injection of bone cement). This is a single-use device.

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All INSTRUMENT, BIOPSY devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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