TRUGUIDE C2016ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00801741085109), received between Jun 28, 2018 and Oct 9, 2025 — classified as 6 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 11, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDE PELVIC ABSCESS BIOPSY USING THE COAXIAL BIOPSY NEEDLE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE NEEDLE ALLEGEDLY BROKE AT 4 CM. THE 8CM NEEDLE PIECE REMAINED INSIDE THE PATIENT AND REQUIRED SURGICAL INTERVENTION TO REMOVE. HOWEVER, THE CURRENT PATIENT STATUS UNKNOWN.

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

  MAUDE report 23023585 ↗
• MalfunctionAug 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDE LUNG BIOPSY PROCEDURE VIA SOFT DENSITY TISSUE USING THE TRUEGUIDE DEVICE. PRIOR THE PROCEDURE, THE PACKAGING AND GOODS ARE NOT MATCHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697280 ↗
• MalfunctionAug 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDE LUNG BIOPSY PROCEDURE VIA SOFT DENSITY TISSUE USING THE TRUEGUIDE DEVICE. PRIOR THE PROCEDURE, THE PACKAGING AND GOODS ARE NOT MATCHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697278 ↗
• MalfunctionAug 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDE LUNG BIOPSY PROCEDURE VIA SOFT DENSITY TISSUE USING THE TRUEGUIDE DEVICE. PRIOR THE PROCEDURE, THE PACKAGING AND GOODS ARE NOT MATCHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697277 ↗
• MalfunctionAug 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDE LUNG BIOPSY PROCEDURE VIA SOFT DENSITY TISSUE USING THE TRUEGUIDE DEVICE. PRIOR THE PROCEDURE, THE PACKAGING AND GOODS ARE NOT MATCHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697276 ↗
• MalfunctionAug 4, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ON (B)(6) 2025, A PATIENT UNDERWENT A COMPUTED TOMOGRAPHY GUIDE LUNG BIOPSY PROCEDURE VIA SOFT DENSITY TISSUE USING THE TRUEGUIDE DEVICE. PRIOR THE PROCEDURE, THE PACKAGING AND GOODS ARE NOT MATCHING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22697275 ↗
• MalfunctionJul 15, 2024Break; Break

  IT WAS REPORTED THAT DURING A COMPUTED TOMOGRAPHY GUIDED LUNG BIOPSY PROCEDURE THROUGH NORMAL DENSITY TISSUE, THE STYLET PART OF THE NEEDLE ALLEGEDLY BROKE OFF INSIDE THE PATIENT'S BODY. REPORTEDLY, THE BROKEN FRAGMENTS OF THE DEVICE WERE REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747154 ↗
• InjuryMay 4, 2023Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT IS REPORTED THAT DURING A BIOPSY PROCEDURE, COAXIAL NEEDLE WAS ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT THE NEEDLE ALLEGEDLY FRACTURED. REPORTEDLY NEEDLE FRAGMENT WAS DISSECTED OUT WITH INCISION AND REMOVED WITH HEMOSTAT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 16866113 ↗
• MalfunctionFeb 15, 2022Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DISTAL END OF THE NEEDLE ALLEGEDLY BROKE INSIDE THE PATIENT. THE CURRENT PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534685 ↗
• MalfunctionFeb 14, 2022Break; Break

  IT WAS REPORTED THAT DURING A BIOPSY PROCEDURE, THE DISTAL PIECE OF THE DEVICE ALLEGEDLY BROKE DURING ADVANCEMENT. THE BROKEN PIECE CAME OUT OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13521366 ↗
• MalfunctionJul 2, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT PRIOR TO A LUNG BIOPSY, THE DEVICE ALLEGEDLY HAD INCOMPATIBILITY ISSUE AND THE NEEDLE TIP WAS ALLEGEDLY BROKEN WHILE FORCEFUL INSERTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108100 ↗
• InjuryJun 28, 2018Break; Migration or Expulsion of Device; Detachment of Device or Device Component; Material Twisted/Bent; Break; Migration or Expulsion of Device; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A BIOPSY, THE COAXIAL INTRODUCER FRACTURED INSIDE THE PATIENT. IT WAS FURTHER REPORTED THAT THE FRAGMENT WAS REMOVED THROUGH THE PATIENT'S ABDOMEN VIA SURGICAL INTERVENTION. POST SURGERY, THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7648894 ↗