TRUGUIDE C2020ARecalls & reported problems
Bard Peripheral Vascular, Inc. · TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop and Additional Blunt Tip Stylet, 19g x 17.8cm · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741085123), received between Jun 27, 2018 and May 8, 2024 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Detachment of Device or Device Component1
- Improper or Incorrect Procedure or Method1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Break; Improper or Incorrect Procedure or Method; Material Twisted/Bent; Break; Improper or Incorrect Procedure or Method; Material Twisted/Bent
IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED PELVIC ASPIRATION PROCEDURE THROUGH NORMAL DENSITY TISSUE, WHEN PHYSICIAN PULLED BACK ON SYRINGE TO ASPIRATE THE ABSCESS, THE HUB WAS ALLEGEDLY BROKEN OFF FROM THE NEEDLE. IT WAS FURTHER REPORTED THAT BROKEN NEEDLE WAS REMOVED BY USING FORCEPS. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19267002 ↗MalfunctionFeb 10, 2022Break; Break
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE NEEDLE ALLEGEDLY BROKE OFF IN THE PATIENT'S LOWER BACK. THE DEVICE WAS REPORTED TO BE REMOVED OFF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13506050 ↗InjuryJun 27, 2018Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A CT-GUIDED LUNG BIOPSY, FRAGMENT OF THE COAXIAL SHEARED OFF INTO THE PATIENT. CAT SCAN CONFIRMED THAT THREE INCHES OF THE COAXIAL GOT STUCK INSIDE THE RIB. IT WAS FURTHER REPORTED THAT SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE NEEDLE FRAGMENT. POST SURGERY, THERE WERE NO SIGNS OF PNEUMOTHORAX AND THE PATIENT'S CONDITION WAS STABLE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7644086 ↗
Other Biopsy needle devices
- MAGNUM MN1410Bard Peripheral Vascular, Inc. · Biopsy needle1 recall118 reports
- 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.