TRUGUIDE C1410BRecalls & reported problems
Bard Peripheral Vascular, Inc. · TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop, 13g x 7cm · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741084898), received between Jan 10, 2025 and Mar 6, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
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
- Device Markings/Labelling Problem1
- Device-Device Incompatibility1
- Difficult to Remove1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 6, 2026Device Markings/Labelling Problem
A PATIENT WAS GETTING PREPARED FOR A BIOPSY PROCEDURE USING TRUGUIDE DEVICE. PRIOR TO THE PROCEDURE, IT WAS REPORTED THAT THE FONT ON BOTH THE BOX AND THE INDIVIDUAL DEVICES IS DANGEROUSLY SMALL. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24529017 ↗MalfunctionJan 10, 2025Difficult to Remove; Device-Device Incompatibility; Material Deformation; Difficult to Remove; Device-Device Incompatibility; Material Deformation
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE BIOPSY GUN WAS ALLEGEDLY NOT REMOVED FROM THE PATIENT BECAUSE IT WAS STUCK IN THE END OF GUIDE NEEDLE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21122238 ↗
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- 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.