TRUGUIDE C1820ARecalls & reported problems
Bard Peripheral Vascular, Inc. · TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop and Additional Blunt Tip Stylet, 17g x 17.8cm · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741085055), received between Jan 10, 2017 and Mar 17, 2026 — classified as 5 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
- Device Contamination with Chemical or Other Material2
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 17, 2026Break
ON (B)(6), 2026, A PATIENT UNDERWENT A ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE BY USING TRUGUIDE INSTRUMENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THE COAXIAL NEEDLE GOT ALLEGEDLY BREAK. COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615387 ↗MalfunctionJul 24, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED OVARIAN BIOPSY WITH THE TRUGUIDE NEEDLE. DURING THE PROCEDURE, THE NEEDLE SUDDENLY BROKE AT THE EXTERNAL NEEDLE-HOLDING SITE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22584953 ↗MalfunctionNov 4, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE RUST WAS ALLEGEDLY FOUND ON THE NEEDLE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15728886 ↗MalfunctionOct 21, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO AN ULTRASOUND GUIDED PROSTATE BIOPSY THROUGH SOFT DENSITY TISSUE, THE DEVICE ALLEGEDLY CONTAMINATED. COAXIAL WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15649732 ↗MalfunctionJan 10, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT UPON OPENING THE FIVE PACK BOX, THE BOX ALLEGEDLY ONLY CONTAINED THREE DEVICES. THERE WAS NO PATIENT CONTACT.
Patient problems: No Patient Involvement
MAUDE report 6237380 ↗
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.