Trek TKL1010Recalls & reported problems
Bard Peripheral Vascular, Inc. · Trek™ Bone Lesion Biopsy Kit, 10g x 10cm Introducer, 12g x 14.8cm Biopsy · Class 2
All models of Trek (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741201424), received between Dec 18, 2023 and Feb 27, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Premature 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.
Reports received per month
Most reported problems
Device problems
- Premature Separation2
- Device Contamination with Chemical or Other Material1
- Difficult or Delayed Separation1
- Difficult to Remove1
- Material Perforation1
- Mechanical Jam1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Difficult to Remove; Difficult or Delayed Separation
ON (B)(6) 2026, A PATIENT UNDERWENT A BONE BIOPSY PROCEDURE USING THE TREK BONE LESION BIOPSY KIT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE WAS ALLEGEDLY JAMMED WITHIN THE TREK QUICK CONNECT HUB AND HAD TO PULL THE ENTIRE NEEDLE OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24466393 ↗MalfunctionJan 24, 2024Material Perforation; Mechanical Jam; Premature Separation; Material Perforation; Mechanical Jam; Premature Separation
IT WAS REPORTED THAT DURING A BONE LESION BIOPSY PROCEDURE, THE QUICK CONNECT HUB WAS ALLEGEDLY DISCONNECTED FROM THE DRIVER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18569126 ↗MalfunctionDec 18, 2023Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation; Device Contamination with Chemical or Other Material; Unintended Movement; Premature Separation
IT WAS REPORTED THAT PRIOR TO A BONE LESION BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY WOBBLED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18344482 ↗
Other INSTRUMENT, BIOPSY devices
- MAX-CORE MC1616Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall4,258 reports
- ENCOR® ECP017GSenorx, Inc. · INSTRUMENT, BIOPSY1 recall4,186 reports
- MAX-CORE MC1820Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall2,404 reports
- MAX-CORE MC1816Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall1 death848 reports
- MAX-CORE MC1410Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall399 reports
- MAX-CORE MC1610Bard Peripheral Vascular, Inc. · INSTRUMENT, BIOPSY1 recall394 reports
- ENCOR® ECP0110GVSenorx, Inc. · INSTRUMENT, BIOPSY392 reports
- ENCOR® ECP0110GSenorx, Inc. · INSTRUMENT, BIOPSY390 reports
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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