TrekRecalls & reported problems across all models
Bard Peripheral Vascular, Inc. · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 43
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 8 models of Trek by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 43 adverse event reports in the FDA's MAUDE database, received between Jun 16, 2023 and Aug 19, 2026 — classified as 3 injuries, 40 malfunctions.
The most frequently reported specific device problem is “Break” (13 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Trek problems
Device problems
- Break13
- Device Contamination with Chemical or Other Material12
- Failure to Obtain Sample10
- Premature Separation10
- Difficult to Remove9
- Unintended Movement8
- Difficult or Delayed Separation7
- Crack6
Patient problems
- No Clinical Signs, Symptoms or Conditions40
- Foreign Body In Patient2
- Unspecified Infection1
Trek models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Trek TKM1110INSTRUMENT, BIOPSY16 reports
- Trek TKL1110INSTRUMENT, BIOPSY13 reports
- Trek TKDRIVERINSTRUMENT, BIOPSY7 reports
- Trek TKL1010INSTRUMENT, BIOPSY3 reports
- Trek TKM1115INSTRUMENT, BIOPSY1 report
- Trek TKL1006INSTRUMENT, BIOPSY1 report
- Trek TKL1106INSTRUMENT, BIOPSY1 report
- Trek TKL1115INSTRUMENT, BIOPSY1 report
Recent Trek adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 19, 2026Break; Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50315566 ↗MalfunctionAug 19, 2026Break; Failure to Obtain Sample
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50315565 ↗MalfunctionAug 12, 2026Difficult to Remove
On (b)(6) 2026, a patient underwent a bone marrow biopsy procedure using a Trek Driver and a Trek Bone Marrow Biopsy Kit. During the procedure, there was no difficulty inserting the Needle Hub into the Quick Connect Hub, and it clicked into place as expected. When the Quick Connect Hub was moved to one of the disconnect positions, the Needle Hub could be removed without resistance. However, difficulty was encountered when attempting to remove the needle from the patient. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218296 ↗MalfunctionMay 25, 2026Break; Failure to Obtain Sample
ON (B)(6) 2026, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING TREK BONE MARROW BIOPSY KIT. DURING THE PROCEDURE, THE CANNULA CRACKED WHILE ATTEMPTING TO ASPIRATE, AND ASPIRATION COULD NOT BE PERFORMED. ADDITIONALLY, IT WAS REPORTED THAT THE CANULA WAS ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25268885 ↗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 ↗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 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 ↗MalfunctionNov 18, 2025Difficult to Remove; Material Twisted/Bent; Positioning Problem; Difficult to Remove; Material Twisted/Bent; Positioning Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A STEREOTACTIC GUIDANCE BIOPSY PROCEDURE USING THE TREK BONE MARROW KIT. DURING THE PROCEDURE, THE DEVICE BENT AND STUCK. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23578294 ↗InjuryNov 17, 2025Break; Break
ON (B)(6) 2025, A 16-YEAR-OLD MALE PATIENT UNDERWENT A BONE BIOPSY PROCEDURE USING THE TREK BONE MARROW BIOPSY KIT. DURING PROCEDURE, THE TIP OF THE NEEDLE ALLEGEDLY BROKE OFF IN THE PATIENT'S BONE. IT WAS FURTHER REPORTED THAT THE MANUAL HAND PIECE ALLEGEDLY BROKE WHEN ATTEMPTING TO RETRIEVE THE CORE FROM THE CANNULA POST BIOPSY AND THE BROKEN PIECE WAS LEFT STUCK IN THE PATIENT'S BONE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF PATIENT UNKNOWN.
Patient problems: Foreign Body In Patient
MAUDE report 23566308 ↗MalfunctionOct 15, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON (B)(6) 2025, A PATIENT UNDERWENT BONE BIOPSY PROCEDURE USING TREK BONE MARROW KIT INSTRUMENT. PRIOR TO THE PROCEDURE THERE WAS A BUG CRAWLING AROUND THE DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288623 ↗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 ↗MalfunctionSep 10, 2025Break; Crack; Failure to Obtain Sample; Break; Crack; Failure to Obtain Sample
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TREK BONE MARROW. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE ALLEGEDLY FAILED TO OBTAIN THE SAMPLE, AND THE SEAL WAS FOUND BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23013117 ↗MalfunctionJul 30, 2025Crack; Difficult to Remove; Material Perforation; Device-Device Incompatibility; Difficult or Delayed Separation; Crack; Difficult to Remove; Material Perforation; Device-Device Incompatibility; Difficult or Delayed Separation
ON (B)(6) 2025, A PATIENT UNDERWENT A BONE MARROW BIOPSY PROCEDURE USING THE TREK BONE MARROW BIOPSY SYSTEM, THE BLUE HUB OF THE NEEDLE HAD SEEMED TO BE TOO LARGE TO CLICK INTO PLACE ON THE STERILE SLEEVE. FURTHER, THE NEEDLE WAS UNABLE TO REMOVE FROM THE QUICK CONNECT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22666184 ↗
Other Bard Peripheral Vascular, Inc. products
- MAX-CORE11 models · 8,845 reports · 1 recall
- DENALI Vena Cava Filter2 models · 1,021 reports
- MAGNUM19 models · 571 reports · 1 recall
- Conquest32 models · 560 reports
- Ultraverse RX56 models · 536 reports
- Fluency Endovascular Stent Graft51 models · 532 reports
- Atlas Gold33 models · 427 reports
- Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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