TRUGUIDE C1616ARecalls & reported problems
Bard Peripheral Vascular, Inc. · TRUGUIDE® Disposable Coaxial Biopsy Needle with Depth Stop, 15g x 13.8cm · Class 2
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741084966), received between Dec 22, 2023 and Feb 17, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (9 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
- Device Markings/Labelling Problem9
- Break3
- Component Misassembled2
- Device Contamination with Chemical or Other Material2
- Device-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions14
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 17, 2026Device Markings/Labelling Problem
ON (B)(6) 2026, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY BIOPSY PROCEDURE USING THE MISSION AND COAXIAL. DURING THE PROCEDURE, THE DEVICE COAXIAL THAT WAS PACKAGED/LABELED INCORRECTLY. FURTHER IT WAS REPORTED THAT LABELED AS A FIFTEEN G BIOPSY CANNULA BUT WAS UNABLE TO FIT 1616MS DOWN IT. COAXIAL NEEDLE WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361873 ↗MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE COAXIAL. DURING THE PROCEDURE, THE DEVICE MISMATCHED WITH THE SIZE OF BIOPSY NEEDLE DUE TO WRONG LABELING OF COAXIAL NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23120570 ↗MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device-Device Incompatibility; Device Markings/Labelling Problem; Device-Device Incompatibility
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE COAXIAL. DURING THE PROCEDURE, THE DEVICE MISMATCHED WITH THE SIZE OF BIOPSY NEEDLE DUE TO WRONG LABELING OF COAXIAL NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23120430 ↗MalfunctionSep 23, 2025Device Markings/Labelling Problem; Device-Device Incompatibility; Device Markings/Labelling Problem; Device-Device Incompatibility
ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE KIDNEY BIOPSY PROCEDURE VIA NORMAL DENSITY TISSUE USING THE COAXIAL. DURING THE PROCEDURE, THE DEVICE MISMATCHED WITH THE SIZE OF BIOPSY NEEDLE DUE TO WRONG LABELING OF COAXIAL NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23120427 ↗MalfunctionSep 18, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY-GUIDED LYMPH BIOPSY THROUGH NORMAL DENSITY TISSUE USING A TRUGUIDE DEVICE. DURING THE PROCEDURE, THE COAXIAL NEEDLE WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO REPORTED PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082588 ↗MalfunctionSep 18, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A CT GUIDED LYMPH BIOPSY PROCEDURE USING NORMAL DENSITY TISSUE WITH TRUGUIDE DEVICE. DURING THE PROCEDURE, THE COAXIAL NEEDLE WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082359 ↗MalfunctionSep 18, 2025Break; Break
ON (B)(6) 2025, A PATIENT UNDERWENT A CT GUIDED LYMPH BIOPSY PROCEDURE USING NORMAL DENSITY TISSUE WITH TRUGUIDE DEVICE. DURING THE PROCEDURE, THE COAXIAL NEEDLE WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23082358 ↗MalfunctionSep 2, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY-GUIDED RENAL BIOPSY PROCEDURE UTILIZING THE MAXCORE AND TRUEGUIDE SYSTEMS. DURING THE PROCEDURE, THE DEVICE WAS FOUND TO BE IN IMPROPER PACKAGING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ALTERNATIVE DEVICE. THERE WERE NO REPORTED INJURIES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22936213 ↗MalfunctionAug 18, 2025Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled
ON (B)(6) 2025, RECEIVED A COMPLAINT DEFINES THAT A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TRUGUIDE COAXIAL NEEDLE. PRIOR THE PROCEDURE, THE PRODUCT WAS NOT APPROPRIATE AS IT WAS MUCH SHORTER THAN 15G. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22826815 ↗MalfunctionAug 18, 2025Device Markings/Labelling Problem; Component Misassembled; Device Markings/Labelling Problem; Component Misassembled
ON (B)(6) 2025, RECEIVED A COMPLAINT DEFINES THAT A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TRUGUIDE COAXIAL NEEDLE. PRIOR THE PROCEDURE, THE PRODUCT WAS NOT APPROPRIATE AS IT WAS MUCH SHORTER THAN 15G. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22826813 ↗MalfunctionJun 18, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TRUGUIDE. PRIOR TO THE PROCEDURE, IT WAS NOTED THE INCORRECT LENGTH TRUGUIDE WAS PACKAGED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22278453 ↗MalfunctionJun 7, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem
ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TRUGUIDE. PRIOR TO THE PROCEDURE, IT WAS NOTED THE INCORRECT LENGTH TRUGUIDE WAS PACKAGED. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22163982 ↗MalfunctionMar 26, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO A RENAL BIOPSY PROCEDURE, AN IMPURITY WAS ALLEGEDLY FOUND IN THE COAXIAL BIOPSY NEEDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984407 ↗MalfunctionDec 22, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT PRIOR TO A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY HAD A FOREIGN PARTICLE INSIDE THE PRIMARY CONTAINER. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18381845 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.