TRUGUIDE C1820BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741085062), received between May 30, 2018 and Sep 21, 2026 — classified as 1 injury, 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.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 22, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED BIOPSY, THE COAXIAL ALLEGEDLY BROKE INSIDE THE PATIENT. THE DEVICE WAS REMOVED IN AN ADDITIONAL SURGERY OPERATION. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Injury

  MAUDE report 10082873 ↗
• MalfunctionJul 2, 2018Break; Break

  IT WAS REPORTED THAT POST ULTRASOUND-GUIDED LIVER BIOPSY, THE DISTAL TIP OF THE COAXIAL CANNULA ALLEGEDLY APPEARED TRUNCATED UPON REMOVAL FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656930 ↗
• MalfunctionMay 30, 2018Material Fragmentation

  AT TERMINATION OF AN ULTRASOUND GUIDED LIVER BIOPSY PROCEDURE AND REMOVAL OF COAXIAL NEEDLE, THE DISTAL TIP OF THE OUTER COAXIAL CANNULA APPEARED TO BE TRUNCATED. THEREFORE THERE WAS CONCERN FOR A RETAINED FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7552842 ↗