TRUGUIDE C1810ARecalls & reported problems
Bard Peripheral Vascular, Inc. · TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop and Additional Blunt Tip Stylet, 17g x 7.8cm · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741085000), received between Aug 24, 2017 and Aug 5, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Detachment of Device or Device Component3
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Injury1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED BIOPSY PROCEDURE IN NECK FOR THYROID VIA NORMAL DENSITY TISSUE USING THE TRUGUIDE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE DEVICE NEEDLE 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 22712031 ↗InjuryMar 15, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A FLUOROSCOPIC GUIDED BONE BIOPSY PROCEDURE, 2CM OF THE NEEDLE OF THE DEVICE ALLEGEDLY BROKE OFF. NO ADDITIONAL INTERVENTION WAS REPORTED TO BE DONE TO RECOVER THE NEEDLE. PATIENT CURRENT STATUS IS UNKNOWN.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11482547 ↗InjuryMay 3, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CT-GUIDED BIOPSY OF A CIRRHOTIC LIVER OF NORMAL DENSITY, THE NEEDLE OF THE DEVICE ALLEGEDLY BROKE OFF INSIDE THE PATIENT AFTER THE PROCEDURE WAS COMPLETED. IT WAS FURTHER REPORTED THAT THE NEEDLE WAS SURGICALLY REMOVED FROM THE PATIENT. THE PATIENT IS REPORTEDLY FINE.
Patient problems: Injury
MAUDE report 8578726 ↗InjuryAug 24, 2017Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A PLEURAL PUNCTURE UNDER ULTRASOUND GUIDANCE, THE NEEDLE ALLEGEDLY DETACHED WITHIN THE INTERCOSTAL SPACE. IT WAS FURTHER REPORTED THAT A SURGICAL PROCEDURE UNDER LOCAL ANESTHESIA WAS PERFORMED TO REMOVE THE DETACHED SEGMENT. THE PATIENT HAS BEEN TRANSFERRED TO THE INTENSIVE CARE DEPARTMENT FOR PLEURAL DRAINAGE. THE CURRENT PATIENT STATUS IS UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6819135 ↗
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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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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