TRUGUIDE C1816ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741085031), received between Jan 10, 2017 and Dec 4, 2025 — classified as 7 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 23119448 ↗
• 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 23119333 ↗
• MalfunctionJul 24, 2025Break; Break

  ON (B)(6) 2025, A PATIENT UNDERWENT AN UTERINE FIBROID PUNCTURE USING THE TRUGUIDE NEEDLE. IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE WAS ALLEGEDLY BROKEN AT THE NEEDLE-HOLDING SITE OUTSIDE THE BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584958 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT POST LIVER BIOPSY PROCEDURE, THE PATIENT HEART RATE SUDDENLY INCREASED, AND HIS BLOOD PRESSURE DECREASED. IT WAS FURTHER REPORTED THAT THE PHENYLEPHRINE INJECTION TO STOP THE BLEEDING AND DOPAMINE HYDROCHLORIDE INJECTION TO MAINTAIN BLOOD PRESSURE. AFTER EMERGENCY RESCUE WITH TRANSCATHETER ARTERIAL EMBOLIZATION OF THE LIVER, HE SUCCESSFULLY STOPPED BLEEDING. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 20830835 ↗
• InjuryJul 18, 2024Break; Difficult to Remove; Break; Difficult to Remove

  IT WAS REPORTED THAT DURING COMPUTED TOMOGRAPHY GUIDED BIOPSY PROCEDURE, THE COAXIAL GUIDE NEEDLE SHAFT ALLEGEDLY BROKE APPROXIMATELY 1.5 CM BELOW THE SKIN SURFACE OF THE PATIENT. IT WAS FURTHER REPORTED THAT A SMALL SKIN INCISION WAS MOVER OVER THE RETAINED FRAGMENT. REPORTEDLY, THE BROKEN PART OF THE DEVICE WAS RETRIEVED BY BLUNT DISSECTION AND FORCEPS. IT WAS FURTHER REPORTED THAT THE BROKEN NEEDLE WAS ALLEGEDLY DIFFICULT TO REMOVE AND COAXIAL WAS USED. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19769033 ↗
• MalfunctionJan 30, 2024Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LUNG BIOPSY PROCEDURE, THE COAXIAL NEEDLE WAS NOT TOTALLY BROKEN BUT WAS ALLEGEDLY BENT VERY BADLY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18604477 ↗
• InjurySep 27, 2023Difficult to Insert; Material Twisted/Bent; Difficult to Insert; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LUNG BIOPSY PROCEDURE, THE NEEDLE WAS ALLEGEDLY NOT BEING INSERTED SMOOTHLY AND THE NEEDLE WAS ALLEGEDLY BEING BENT, RESULTING IN SAMPLING FAILURE. IT WAS FURTHER REPORTED THAT THERE WERE ALSO ADVERSE EVENTS OF INJURY, SUCH AS POSTOPERATIVE CHEST CATHETER DRAINAGE AND MASSIVE PNEUMOTHORAX, WHICH WERE REPORTED TO THE RESPONSIBLE DEPARTMENT FOR KEY MONITORING AFTER DISCOVERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Pneumothorax

  MAUDE report 17823963 ↗
• MalfunctionDec 25, 2022Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING RENAL BIOPSY PROCEDURE, THE DEVICE WAS ALLEGEDLY DIFFICULT TO REMOVE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16046064 ↗
• MalfunctionNov 26, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT PRIOR TO BIOPSY PROCEDURE, COAXIAL BIOPSY NEEDLE WAS FOUND UNSEALED UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15866802 ↗
• InjuryJan 9, 2020Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY, THE INTRODUCER NEEDLE ALLEGEDLY BROKE INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT A CUT DOWN WAS REQUIRED TO REMOVE THE BROKEN PIECE OF DEVICE. THE CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Injury

  MAUDE report 9572244 ↗
• InjuryAug 28, 2019Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DEVICE ALLEGEDLY BROKE OFF INSIDE THE PATIENT. ADDITIONAL MEDICAL INTERVENTION WAS THEN REQUIRED TO REMOVE THE DEVICE FROM THE PATIENT. THE DEVICE WAS SUCCESSFULLY REMOVED.

  Patient problems: Injury

  MAUDE report 8941577 ↗
• MalfunctionJan 25, 2019Break; Break

  IT WAS REPORTED THAT DURING A CT-GUIDED BIOPSY, THE COAXIAL NEEDLE ALLEGEDLY BROKE AT THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8279764 ↗
• InjuryFeb 6, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ULTRASOUND GUIDED LIVER BIOPSY, AFTER THREE TISSUE SAMPLES WERE OBTAINED, THE BIOPSY NEEDLE AND COAXIAL WERE REMOVED FROM THE PATIENT AND A SEGMENT OF THE COAXIAL NEEDLE HAD ALLEGEDLY BECAME DETACHED AND REMAINED IN THE PATIENT'S LIVER. AN INCISION WAS MADE TO REMOVE THE DETACHED SEGMENT UNDER FLUOROSCOPY. GEL FOAM SLURRY WAS INJECTED AND THE INCISION WAS SUTURED CLOSED. THE PATIENT WAS REPORTEDLY IN GOOD CONDITION AND NO FURTHER INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6306054 ↗
• MalfunctionJan 10, 2017Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE FIVE PACK BOX, THE BOX ALLEGEDLY ONLY CONTAINED THREE DEVICES. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 6237387 ↗