TRUGUIDERecalls & reported problems across all models

We found 14 models of TRUGUIDE by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Jan 10, 2017 and Sep 21, 2026 — classified as 23 injuries, 55 malfunctions.

The most frequently reported specific device problem is “Break” (35 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported TRUGUIDE problems

TRUGUIDE models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• TRUGUIDE C1816A

  Biopsy needle
  16 reports
• TRUGUIDE C2016A

  Biopsy needle
  15 reports
• TRUGUIDE C1616A

  Biopsy needle
  14 reports
• TRUGUIDE C1820B

  Biopsy needle
  6 reports
• TRUGUIDE C1816B

  Biopsy needle
  5 reports
• TRUGUIDE C1820A

  Biopsy needle
  5 reports
• TRUGUIDE C1810A

  Biopsy needle
  4 reports
• TRUGUIDE C2010A

  Biopsy needle
  4 reports
• TRUGUIDE C2020A

  Biopsy needle
  3 reports
• TRUGUIDE C1410B

  Biopsy needle
  2 reports
• TRUGUIDE C1410A

  Biopsy needle
  1 report
• TRUGUIDE C1610B

  Biopsy needle
  1 report
• TRUGUIDE C1813B

  Biopsy needle
  1 report
• TRUGUIDE C2016B

  Biopsy needle
  1 report

Recent TRUGUIDE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Illegible Information

  On (b)(6) 2026, a patient underwent a biopsy procedure using a TruGuide coaxial needle. During the procedure, it was found that the needle size and other information on the packaging were printed in a very small font, making the label difficult to read and requiring magnification to clearly identify the needle size. It was further reported that previous packaging had larger, more readable text and that all needles in the latest shipment appeared to have a new label with a smaller font. The BD labeled packaging was reported to have a much smaller font than the Bard labeled packaging, which remained easily readable. The complainant expressed concern that the reduced font size could increase the risk of selecting the incorrect needle size. The affected devices were used on patients, as the concern was limited to the labeling. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50836525 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 27, 2026Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN CT GUIDED BIOPSY PROCEDURE BY USING THE TRUGUIDE COAXIAL. IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. IT WAS FURTHER REPORTED THAT LABELING MISMATCH, THE YELLOW BARCODE LABELS INDICATED C1816A, BUT THE ACTUAL MODEL WAS C1820B. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24466395 ↗
• 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 ↗
• InjuryDec 4, 2025Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDE TRANSHEPATIC BIOPSY PROCEDURE USING THE COAXIAL. DURING THE PROCEDURE, THE DEVICE NEEDLE CONTAINED TWO POINTED-TIP NEEDLES WITHOUT ANY ROUND-TIP NEEDLES. FURTHER IT WAS REPORTED THAT PATIENT EXPERIENCED MINOR BLEEDING DURING THE PROCEDURE, AND GELATIN SPONGE PACKING WAS USED FOR HEMOSTASIS. CURRENT PATIENT STATUS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23713326 ↗
• MalfunctionOct 31, 2025Failure to Obtain Sample; Device Markings/Labelling Problem; Failure to Obtain Sample; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT AN CT GUIDED BIOPSY PROCEDURE USING THE TRUGUIDE COAXIAL. DURING PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO OBTAIN SAMPLE. IT WAS FURTHER REPORTED THAT LABELING MISMATCH, THE YELLOW BARCODE LABELS INDICATED C1816A, BUT THE ACTUAL MODEL WAS C1820B.THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23434369 ↗
• MalfunctionOct 27, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A BIOPSY PROCEDURE USING THE TRUGUIDE. PRIOR THE PROCEDURE, THE DEVICE MEASUREMENT DOSE NOT MATCH WITH MARKING. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388875 ↗
• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A LUNG BIOPSY PROCEDURE USING THE TRUGUIDE. DURING THE PROCEDURE, PATIENT EXPERIENCING PNEUMOTHORAX. HOWEVER, THE CURRENT PATIENT STATUS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 23263145 ↗
• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A LUNG BIOPSY PROCEDURE USING THE TRUGUIDE. DURING THE PROCEDURE, PATIENT EXPERIENCING PNEUMOTHORAX. HOWEVER, THE CURRENT PATIENT STATUS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 23263144 ↗
• InjuryOct 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A LUNG BIOPSY PROCEDURE USING THE TRUGUIDE. DURING THE PROCEDURE, PATIENT EXPERIENCING PNEUMOTHORAX. HOWEVER, THE CURRENT PATIENT STATUS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 23263143 ↗
• 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 23, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ULTRASOUND GUIDED LIVER BIOPSY THROUGH NORMAL DENSITY TISSSUE WITH THE TRUGUIDE NEEDLE. DURING THE PROCEDURE, THE COAXIAL NEEDLE ALLEGEDLY BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23119452 ↗

Other Bard Peripheral Vascular, Inc. products

• MAX-CORE11 models · 8,845 reports · 1 recall
• DENALI Vena Cava Filter2 models · 1,021 reports
• MAGNUM19 models · 571 reports · 1 recall
• Conquest32 models · 560 reports
• Ultraverse RX56 models · 536 reports
• Fluency Endovascular Stent Graft51 models · 532 reports
• Atlas Gold33 models · 427 reports
• Ultraverse 035 PTA Dilatation Catheter92 models · 393 reports