TRUGUIDE C2010ARecalls & reported problems
Bard Peripheral Vascular, Inc. · TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop and Additional Blunt Tip Stylet, 19g x 7.8cm · Class 2
All models of TRUGUIDE (14)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741085079), received between Jun 21, 2019 and May 15, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Difficult to Remove2
- Break1
- Device Contamination with Chemical or Other Material1
- Unsealed Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Injury1
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE COAXIAL GUIDE SLEEVE ALLEGEDLY GOT STUCK DURING REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19327511 ↗MalfunctionAug 7, 2023Difficult to Remove; Device Contamination with Chemical or Other Material; Difficult to Remove; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, RESISTANCE WAS ALLEGEDLY NOT SMOOTH WHEN THE NEEDLE WAS PULLED OUT. IT WAS FURTHER REPORTED THAT AFTER REMOVING THE NEEDLE, IT WAS FOUND THAT THERE WAS AN IRON WIRE INSIDE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17468045 ↗MalfunctionJul 17, 2020Unsealed Device Packaging; Unsealed Device Packaging
THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL C2010A BIOPSY INSTRUMENT ALLEGEDLY EXPERIENCED UNSEALED DEVICE PACKAGING. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE REPORTED MALFUNCTIONS DID NOT INVOLVE A PATIENT, THEREFORE, NO PATIENT INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 10290088 ↗InjuryJun 21, 2019Break; Break
IT WAS REPORTED THAT DURING A CT GUIDED LUNG BIOPSY, THE DEVICE ALLEGEDLY BROKE OFF INSIDE THE PATIENT. THE PATIENT WAS THEN TRANSFERRED TO THE OR WHERE THE DEVICE WAS SUCCESSFULLY REMOVED.
Patient problems: Injury
MAUDE report 8725106 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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