TRUGUIDE C1816BRecalls & reported problems
Bard Peripheral Vascular, Inc. · TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop and Additional Blunt Tip Stylet, 17g x 13cm · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741085048), received between May 16, 2018 and Oct 27, 2025 — classified as 3 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
- Device Markings/Labelling Problem1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TRUGUIDE. PRIOR THE PROCEDURE, THE DEVICE MEASUREMENT DOSE NOT MATCH WITH MARKING. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23388875 ↗InjuryNov 11, 2023Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE BROKEN NEEDLE REMAINED IN THE MUSCLE LAYER OF THE BODY. REPORTEDLY, THE FOREIGN BODY WAS REMOVED BY EMERGENCY SURGERY UNDER LOCAL ANESTHESIA. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18117052 ↗InjuryOct 31, 2023Break; Break
IT WAS REPORTED THAT DURING AN ULTRASOUND-GUIDED BIOPSY THROUGH NORMAL DENSITY TISSUE, THE DEVICE ALLEGEDLY GOT BROKEN APART. IT WAS FURTHER REPORTED THAT THE BROKEN PART WAS REMOVED THROUGH SURGERY. A COAXIAL NEEDLE WAS USED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18042963 ↗MalfunctionMar 10, 2021Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE WAS BROKEN. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11453340 ↗InjuryMay 16, 2018Break; Break
IT WAS REPORTED THAT DURING THE DRAINAGE PROCEDURE GUIDED BY CT, THE COAXIAL ALLEGEDLY BROKE IN THE PATIENT'S MUSCULATURE. THE PATIENT NEEDED TO GO THROUGH A SURGERY PROCEDURE TO WITHDRAWAL THE COAXIAL. THE PATIENT WAS REPORTED AS ASYMPTOMATIC.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7520755 ↗
Other Biopsy needle devices
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- Single Use Aspiration Needle NA-U401SX NA-U401SX-4021Olympus Medical Systems Corp. · Biopsy needle1 recall94 reports
- EchoTip G31520Cook Ireland Ltd · Biopsy needle1 recall84 reports
- Single Use Aspiration Needle NA-201SX-4021Olympus Medical Systems Corp. · Biopsy needle1 death126 reports
- EchoTip ProCore G34785Cook Ireland Ltd · Biopsy needle97 reports
- MAGNUM MN1820Bard Peripheral Vascular, Inc. · Biopsy needle1 recall37 reports
- Single Use Aspiration Needle NA-U401SX NA-U401SX-4022Olympus Medical Systems Corp. · Biopsy needle1 recall29 reports
- Interject M00518250Boston Scientific Corporation · Biopsy needle70 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.