Trek TKL1115Recalls & reported problems
Bard Peripheral Vascular, Inc. · Trek™ Bone Lesion Biopsy Kit, 11g x 15cm Introducer, 13g x 19.8cm 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741201462), received between May 3, 2024 and May 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult to Remove” (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
Most reported problems
Device problems
- Difficult to Remove1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2024Difficult to Remove; Premature Separation; Difficult to Remove; Premature Separation
IT WAS REPORTED THAT DURING BONE A BIOPSY PROCEDURE, WHEN DRILLING OUT OF THE PATIENT, THE DRIVER ALLEGEDLY GOT DISCONNECTED FROM THE HUB. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS ESSENTIALLY SO STUCK IN THE BONE, THAT AS THE DRIVER WAS PULLED OUT, IT ALLEGEDLY GOT DISLODGED FROM THE HUB. REPORTEDLY, THE DRIVER WAS ABLE TO BE RECONNECTED TO THE HUB SINCE IT WAS STILL WRAPPED IN THE STERILE SLEEVE, BUT THE LOCKING MECHANISM SEEMED TO BE WEAKENED. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19237245 ↗
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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