Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD INS-5300Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00815686021207), received between Mar 18, 2021 and Aug 25, 2023 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (9 reports).

2 FDA recall records name this device's identifier, 2 still open.

13 other recalls cover devices cleared under the same FDA submission (K170023); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 10, 2023Class IIOpen, Classified

   Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to design requirements and insufficient evidence to demonstrate adequate electromagnetic compatibility (EMC). EMC is the ability of electrical equipment and systems to function acceptably without interference and to not interfere with other devices within its operating environment

   Z-2662-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. May 15, 2023Class IIOpen, Classified

   Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. This could result in a potential procedural delay

   Z-2267-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionAug 25, 2023Retraction Problem; Retraction Problem

  WHEN THE DOCTOR OPENED THE SUBJECT DEVICE (INS-5300) FROM THE PACKAGING, IT WAS NOTED THAT THE TRIPLE NEEDLE BRUSH WAS ALREADY DEPLOYED, AND THE INSTRUMENT DID NOT HAVE THE CLEAR PROTECTIVE PIECE OF THE TIP. THE NEEDLE WOULD NOT FULLY RETRACT WHEN THE DOCTOR ATTEMPTED TO RETRACT THE BRUSH. THIS REPORT IS BEING SUBMITTED FOR THE TRIPLE NEEDLE BRUSH NOT FULLY RETRACTING. THERE WAS NO HARM TO THE PATIENT OR USER. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED AFTER A MINOR DELAY OF TWO (2) MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17627192 ↗
• InjuryAug 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WITH A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) WAS HAVING A BIOPSY PERFORMED ON A LARGE TARGET IN THE LEFT UPPER LOBE OF THE LUNG. AFTER THE PROCEDURE, THE PATIENT WAS SCANNED AND A PNEUMOTHORAX WAS NOTED. A CHEST TUBE WAS PLACED AND THE PATIENT WAS SENT HOME ON (B)(6) 2021. THE PATIENT RETURNED THE NEXT DAY TO HAVE THE CHEST TUBE REMOVED. THE PATIENT RECOVERED AND WAS DISCHARGED. THE BIOPSY SAMPLES INDICATE THE PATIENT HAD ADENOCARCINOMA. THE DOCTOR USED INS-5410, FLEX NEEDLE, AND INS-5300, TRIPLE NEEDLE BRUSH, TO TAKE THE BIOPSY SAMPLE. ONE MEDWATCH REPORT WAS PREVIOUSLY SUBMITTED FOR THIS EVENT ON MEDWATCH 3007222345-2021-00016 FOR THE INS-5410 ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE, 15MM L, 1.8MM OD. ON FURTHER REVIEW, IT WAS LATER DETERMINED THAT A SEPARATE MEDWATCH REPORT SHOULD HAVE BEEN SUBMITTED FOR THE INS-5300 ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH, 12MM L, 1.8MM OD. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE INS-5300.

  Patient problems: Pneumothorax

  MAUDE report 17552741 ↗
• MalfunctionJun 30, 2023Material Separation; Material Separation

  A VERAN REPRESENTATIVE WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. THE OUTER SHEATH OF THE TRIPLE NEEDLE BRUSH BECAME STRETCHED AND DETATCHED WHILE MAKING PASSES AND TAKING BIOPSIES. THE NEEDLE BRUSH EVENTUALLY WOULD NOT COME OUT OF THE SHEATH. THE STAFF DISPOSED OF THE INSTRUMENT AND THEY DID NOT OPEN ANOTHER TRIPLE NEEDLE BRUSH. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO DELAY. THERE WAS NO INJURY TO A PATIENT OR USER DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243111 ↗
• MalfunctionJun 27, 2023Retraction Problem; Retraction Problem

  THE USER FACILITY REPORTED THAT WHEN THE TECHNICIAN TOOK THE INS-5300 (ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH) OUT OF THE CLEAR PLASTIC CIRCLE, THE BRUSH WAS DEPLOYED OUT OF THE SHEATH. WHEN THE TECHNICIAN FULLY RETRACTED THE BRUSH, THE NEEDLES WERE STILL OUT. WHEN THE TECHNICIAN HELD EACH END OF THE INSTRUMENT AND PULLED APART GENTLY, THIS ALLOWED THE TIP TO SIT PROPERLY INSIDE THE SHEATH. THE STAFF HAD TO DO THIS MULTIPLE TIMES. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED USING THE SUBJECT DEVICE. THERE WAS NO PATIENT OR USER INJURY DUE TO THE REPORTED ISSUE. THIS REPORT IS BEING SUBMITTED FOR THE NEEDLES NOT RETRACTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210745 ↗
• MalfunctionJun 26, 2023Retraction Problem; Retraction Problem

  A VERAN TERRITORY MANAGER WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. THE INS-5300 (ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH) WAS DEPLOYED UPON OPENING. THE CLEAR PROTECTIVE PIECE WAS NOT ON THE END. THE INS-5300 (SUBJECT DEVICE) WOULD NOT RETRACT INSIDE THE SHEATH. STAFF WAS ABLE TO RETRACT THE TIP BACK INTO THE SHEATH BY HOLDING EACH END AND PULLING APART GENTLY. THE STAFF HAD TO DO THIS EVERY TIME. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SUBJECT DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT IS BEING REPORTED FOR NOT BEING ABLE TO RETRACT THE NEEDLE BRUSH INTO THE SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17203916 ↗
• MalfunctionJun 23, 2023Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT THE WIRES OF THREE (3) OF THE INS-5300 (ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH) WERE BENT AT A 90-DEGREE ANGLE NEAR THE HUB WHERE THE BRUSH IS DEPLOYED. ALL THREE WERE NOTICED OUT OF THE PACKAGE, PRIOR TO USE. TWO (2) OF THE WIRES COMPLETELY BROKE AND ONE (1) WAS STILL ABLE TO BE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED BY 5 MINUTES; HOWEVER, THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE ISSUES. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE THIRD INS-5300. THE ISSUE WITH THE SECOND INS-5300 IS BEING REPORTED UNDER MEDWATCH 3007222345-2023-00033. THE ISSUE WITH THE FIRST INS-5300 IS BEING REPORTED UNDER MEDWATCH 3007222345-2023-00032.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195128 ↗
• MalfunctionJun 23, 2023Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT THE WIRES OF THREE (3) OF THE INS-5300 (ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH) WERE BENT AT A 90-DEGREE ANGLE NEAR THE HUB WHERE THE BRUSH IS DEPLOYED. ALL THREE WERE NOTICED OUT OF THE PACKAGE, PRIOR TO USE. TWO (2) OF THE WIRES COMPLETELY BROKE AND ONE (1) WAS STILL ABLE TO BE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED BY 5 MINUTES; HOWEVER, THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE ISSUES. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE SECOND INS-5300. THE ISSUE WITH THE FIRST INS-5300 IS BEING REPORTED UNDER MEDWATCH 3007222345-2023-00032. THE ISSUE WITH THE THIRD INS-5300 IS BEING REPORTED UNDER MEDWATCH 3007222345-2023-00034.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195094 ↗
• MalfunctionJun 23, 2023Material Twisted/Bent; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT THE WIRES OF THREE (3) OF THE INS-5300 (ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH) WERE BENT AT A 90-DEGREE ANGLE NEAR THE HUB WHERE THE BRUSH IS DEPLOYED. ALL THREE WERE NOTICED OUT OF THE PACKAGE, PRIOR TO USE. TWO (2) OF THE WIRES COMPLETELY BROKE AND ONE (1) WAS STILL ABLE TO BE USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED BY 5 MINUTES; HOWEVER, THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE ISSUES. THIS MEDWATCH REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE FIRST INS-5300. THE ISSUE WITH THE SECOND INS-5300 IS BEING REPORTED UNDER MEDWATCH 3007222345-2023-00033. THE ISSUE WITH THE THIRD INS-5300 IS BEING REPORTED UNDER MEDWATCH 3007222345-2023-00034.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195083 ↗
• MalfunctionJun 16, 2023Retraction Problem; Retraction Problem

  DURING A NAVIGATIONAL BRONCHOSCOPY PROCEDURE, THE DOCTOR EXPERIENCED A TRIPLE NEEDLE BRUSH (INS-5300: ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH, 12MM L, 1.8MM OD) NOT FULLING RETRACTING BACK INTO THE SHEATH. THIS WAS NOTICED BEFORE IT EVER ENTERED THE SCOPE/PATIENT. ANOTHER TRIPLE NEEDLE BRUSH WAS OPENED TO COMPLETE THE CASE, BUT THIS SECOND TRIPLE NEEDLE BRUSH EXPERIENCED THE SAME ISSUE. A 21 GA NEEDLE WAS THEN OPENED TO COMPLETE THE CASE. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED AFTER A MINOR DELAY OF 2 MINUTES. THERE WAS NO IMPACT ON THE PATIENT OR THE PROCEDURE. THIS MDR IS BEING SUBMITTED FOR THE ISSUE WITH THE SECOND TRIPLE NEEDLE BRUSH. THE ISSUE WITH THE FIRST TRIPLE NEEDLE BRUSH IS BEING SUBMITTED UNDER MEDWATCH 3007222345-2023-00027.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145064 ↗
• MalfunctionJun 15, 2023Retraction Problem; Retraction Problem

  DURING A NAVIGATIONAL BRONCHOSCOPY PROCEDURE, THE DOCTOR EXPERIENCED A TRIPLE NEEDLE BRUSH (INS-5300: ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH, 12MM L, 1.8MM OD) NOT FULLING RETRACTING BACK INTO THE SHEATH. THIS WAS NOTICED BEFORE IT EVER ENTERED THE SCOPE/PATIENT. ANOTHER TRIPLE NEEDLE BRUSH WAS OPENED TO COMPLETE THE CASE, BUT THIS SECOND TRIPLE NEEDLE BRUSH EXPERIENCED THE SAME ISSUE. A 21 GA NEEDLE WAS THEN OPENED TO COMPLETE THE CASE. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED AFTER A MINOR DELAY OF 2 MINUTES. THERE WAS NO IMPACT ON THE PATIENT OR THE PROCEDURE. THIS MDR IS BEING SUBMITTED FOR THE ISSUE WITH THE FIRST TRIPLE NEEDLE BRUSH. THE ISSUE WITH THE SECOND TRIPLE NEEDLE BRUSH IS BEING SUBMITTED UNDER MEDWATCH 3007222345-2023-00028.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135778 ↗
• MalfunctionMar 10, 2023Retraction Problem; Retraction Problem

  DURING A NAVIGATED THORACIC PROCEDURE, THE PHYSICIAN FOUND THAT AN ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH WOULD NOT RETRACT FULLY INTO THE SHEATH OUT OF THE PACKAGE. A NEW INSTRUMENT WAS OPENED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY OR HARM ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527023 ↗
• MalfunctionMar 10, 2023Retraction Problem; Retraction Problem

  PHYSICIAN FOUND THAT AN ALWAYS-ON TIP TRACKED TRIPLE NEEDLE BRUSH WOULD NOT RETRACT FULLY INTO THE SHEATH OUT OF THE PACKAGE. STAFF WAS ABLE TO RETRACT THE TIP BACK INTO THE SHEATH BY STRETCHING THE INSTRUMENT COMPLETELY STRAIGHT AND PULLING APART GENTLY. THE DEVICE WAS USED TO SAMPLE AND THE BRUSH TIP WAS CUT FOR PATHOLOGY. PROCEDURE WAS COMPLETED. THERE WAS NO INJURY OR HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526618 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  PATIENT DEVELOPED A PNEUMOTHORAX, WHICH REQUIRED A CHEST TUBE AND ADMITTANCE TO THE HOSPITAL AFTER A PROCEDURE WITH THE VERAN SPIN SYSTEM AND ENDOBRONCHIAL INSTRUMENTS.

  Patient problems: Pneumothorax

  MAUDE report 15635202 ↗
• MalfunctionMar 10, 2022Retraction Problem; Material Separation; Retraction Problem; Material Separation

  TRIPLE NEEDLE BRUSH WOULD NOT RETRACT FULLY BACK INTO THE SHEATH OUR OF THE PACKAGE. THE DEVICE WAS NOT USED IN A PROCEDURE AND NEW DEVICE WAS OPENED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725785 ↗
• MalfunctionFeb 1, 2022Break; Material Separation; Insufficient Device Problem Information; Break; Material Separation; Insufficient Device Problem Information

  WHEN ATTEMPTING TO RETRIEVE THE BIOPSY SAMPLE, THE COIL BROKE AND BROKE THROUGH THE BLACK PORTION NEAR THE HUB OF THE INSTRUMENT. STAFF WAS ABLE TO RETRACT THE BRUSH, OPEN A NEW BRUSH, AND COMPLETE THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419095 ↗
• MalfunctionMar 18, 2021Retraction Problem; Material Separation; Insufficient Device Problem Information; Retraction Problem; Material Separation; Insufficient Device Problem Information

  NURSE WAS PRACTICING DEPLOYING AND RETRACTING THE TRIPLE NEEDLE BRUSH. DURING THE PRACTICE AND UPON RETRACTING THE BRUSH, SHE SAW JUST A SLIVER COMPONENT STICKING OUT OF THE SHEATH. THE COMPANY REPRESETATIVE THAT WAS PRESENT FOR THE PROECUDURE WENT TO SPEAK WITH THE NURSE ABOUT THE PROPER PROCEDURE IF THIS HAPPENES, BUT THE NURSE MOVED QUICKLY TO FORCEFULLY RETRACT THE BRUSH AND THE SPEED AND FORCE OF THE RETRACTION CAUSED THE INSTRUMENT TO SEPERATE. THE DEVICE WAS NOT BEING USED ON THE PATIENT AND THE PROCEDURE WAS ABLE TO BE COMPLETED AS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510362 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K170023. One submission often covers many models, so check the product and lot details in each record.

• Z-2664-2023 · Aug 10, 2023 · Open, Classified
  Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm L, 1.8mm OD, 5/BX INS-0382 AOTT 19ga Needle, 12mm L, 1.8 OD, 5/Bx INS-0372 AOTT Serrated For
• Z-2660-2023 · Aug 10, 2023 · Open, Classified
  Veran Endobronchial: Models: INS-5925 SPiN Access Catheter 180 Degree for use w/ Pentax Scopes INS-5920 SPiN Access Catheter 90 Degree for use w/ Pentax Scopes INS-5915 SPi
• Z-2661-2023 · Aug 10, 2023 · Open, Classified
  Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm, 5/Bx (includes INS-5028)" INS-5611 SPiN Perc Localization Needle - 2cm, 5/Bx INS-5610 SPiN
• Z-2663-2023 · Aug 10, 2023 · Open, Classified
  Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Universal Tracker, LG 7-12ga INS-5039 Always-On vTrack Universal Tracker, SM/CL, 12-18ga INS-5036 "
• Z-2659-2023 · Aug 10, 2023 · Open, Classified
  Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50H
• Z-2266-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures wher
• Z-2265-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 19ga ANSO Histology Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures whe
• Z-2269-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) SPiN Xtend 2.0mm OD, 21ga Intended for use in clinical interventions and for anatomical structures where computed tomogr
• Z-2263-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, Oval Cup-Intended for use in clinical interventions and for anatomical structures where computed tomo
• Z-2264-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Serrated Cup-Intended for use in clinical interventions and for anatomical structures where computed t
• Z-2262-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Brush, 15mm L, 1.8mm OD Intended for use in clinical interventions and for anatomical structures where computed tomograph
• Z-2268-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) 22ga SPiN Flex Needle, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where co
• Z-1103-2023 · Dec 13, 2022 · Open, Classified
  SPiN Thoracic Navigation System Model: SYS-4000 (SYS-4000D)