Always-On Tip Tracked Brush, 15mm L, 1.8mm OD INS-0352Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00815686020538), received between Dec 8, 2021 and Jun 29, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Separation” (15 reports).

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

11 other recalls cover devices cleared under the same FDA submission (K122106); 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-2664-2023 · 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-2262-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionJun 29, 2023Material Separation; Material Separation

  THE PHYSICIAN STATED DURING THE FIRST PASS WITH THE BRUSH (INS-0352 ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD), THE BRUSH WAS BROKEN AT THE MOST DISTAL PART OF THE BLACK PIECE. THE STAFF MENTIONED IT SEEMED THE SHEATH WAS SLIDING WITHIN THE BLACK HANDLE, SO WHEN THE DOCTOR WOULD "BRUSH OUT", IT WAS STILL INSIDE THE SHEATH. THE PHYSICIAN DECIDED TO CUT THE BRUSH TO SEND TO PATHOLOGY. THERE WAS AN APPROXIMATE 10-MINUTE PROCEDURE DELAY; HOWEVER, THERE WAS NO HARM OR INJURY TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17230431 ↗
• MalfunctionJun 29, 2023Material Separation; Material Separation

  THE PHYSICIAN REPORTED THAT WHILE TRYING TO PLACE A FIDUCIAL MARKER, THE FIRST BRUSH (INS-0352 ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD) BROKE WHEN THE SHEATH SEPARATED FROM THE HUB OF THE HANDLE. THE PHYSICIAN WAS ABLE TO PLACE 2 FIDUCIAL MARKERS WITH A SECOND BRUSH BEFORE THE SHEATH SEPARATED FROM THE HUB OF THE HANDLE. A THIRD BRUSH WAS OPENED, BUT THE PHYSICIAN WAS UNABLE TO PLACE A FIDUCIAL MARKER BEFORE THE SHEATH CAME APART FROM THE HUB OF THE HANDLE. THEY CONFIRMED FIDUCIAL MARKER PLACEMENT USING FLUOROSCOPY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE. THERE WAS NO PROCEDURE DELAY AND THERE WAS NO INJURY TO A PATIENT OR USER AS A RESULT OF THE REPORTED ISSUES. THIS REPORT (3007222345-2023-00044) IS BEING SUBMITTED FOR THE ISSUE WITH THE THIRD INS-0352. THE ISSUE WITH THE FIRST INS-0352 IS BEING REPORTED ON MEDWATCH 3007222345-2023-00042. THE ISSUE WITH THE SECOND INS-0352 IS BEING REPORTED ON MEDWATCH 3007222345-2023-00043.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226495 ↗
• MalfunctionJun 29, 2023Material Separation; Material Separation

  THE PHYSICIAN REPORTED THAT WHILE TRYING TO PLACE A FIDUCIAL MARKER, THE FIRST BRUSH (INS-0352 ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD) BROKE WHEN THE SHEATH SEPARATED FROM THE HUB OF THE HANDLE. THE PHYSICIAN WAS ABLE TO PLACE 2 FIDUCIAL MARKERS WITH A SECOND BRUSH BEFORE THE SHEATH SEPARATED FROM THE HUB OF THE HANDLE. A THIRD BRUSH WAS OPENED, BUT THE PHYSICIAN WAS UNABLE TO PLACE A FIDUCIAL MARKER BEFORE THE SHEATH CAME APART FROM THE HUB OF THE HANDLE. THEY CONFIRMED FIDUCIAL MARKER PLACEMENT USING FLUOROSCOPY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE. THERE WAS NO PROCEDURE DELAY AND THERE WAS NO INJURY TO A PATIENT OR USER AS A RESULT OF THE REPORTED ISSUES. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE SECOND INS-0352. THE ISSUE WITH THE FIRST INS-0352 IS BEING REPORTED ON MEDWATCH 3007222345-2023-00042. THE ISSUE WITH THE THIRD INS-0352 IS BEING REPORTED ON MEDWATCH 3007222345-2023-00044.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226427 ↗
• MalfunctionJun 29, 2023Material Separation; Material Separation

  THE PHYSICIAN REPORTED THAT WHILE TRYING TO PLACE A FIDUCIAL MARKER, THE FIRST BRUSH (INS-0352 ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD) BROKE WHEN THE SHEATH SEPARATED FROM THE HUB OF THE HANDLE. THE PHYSICIAN WAS ABLE TO PLACE 2 FIDUCIAL MARKERS WITH A SECOND BRUSH BEFORE THE SHEATH SEPARATED FROM THE HUB OF THE HANDLE. A THIRD BRUSH WAS OPENED, BUT THE PHYSICIAN WAS UNABLE TO PLACE A FIDUCIAL MARKER BEFORE THE SHEATH CAME APART FROM THE HUB OF THE HANDLE. THEY CONFIRMED FIDUCIAL MARKER PLACEMENT USING FLUOROSCOPY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE. THERE WAS NO PROCEDURE DELAY AND THERE WAS NO INJURY TO A PATIENT OR USER AS A RESULT OF THE REPORTED ISSUES. THIS REPORT (3007222345-2023-00042) IS BEING SUBMITTED FOR THE ISSUE WITH THE FIRST INS-0352. THE ISSUE WITH THE SECOND INS-0352 IS BEING REPORTED ON MEDWATCH 3007222345-2023-00043. THE ISSUE WITH THE THIRD INS-0352 IS BEING REPORTED ON MEDWATCH 3007222345-2023-00044.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226406 ↗
• MalfunctionJun 27, 2023Material Separation; Material Separation

  THE PHYSICIAN REPORTED THAT AFTER THE INS-0352 (ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD) WAS DEPLOYED ONE TIME, THE OUTER CLEAR SHEATH DETACHED FROM THE BLACK HANDLE PORTION WHEN THE BRUSH WAS RETRACTED. THE BRUSH WAS REMOVED FROM THE PATIENT AND WHEN THE TECHNICIAN DEPLOYED THE BRUSH TO EXTRACT THE SAMPLE, THE BRUSH COULD NOT DEPLOY OUT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE USING A NEW INSTRUMENT. THERE WAS NO PROCEDURAL DELAY. THERE WAS NO INJURY TO THE PATIENT OR USER AS A RESULT OF THE REPORTED ISSUE. THIS REPORT IS BEING SUBMITTED FOR THE SHEATH DETACHING FROM THE BLACK HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210680 ↗
• MalfunctionJun 27, 2023Material Separation; Material Separation

  THE PHYSICIAN REPORTED THAT AN INS-0352 (ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD) WAS DEPLOYED ONE TIME. WHEN THE BRUSH WAS RETRACTED, THE SHEATH CAME APART FROM THE BLACK HANDLE. THE SHEATH WAS PULLED OFF OF THE BRUSH TO RETRIEVE THE SAMPLE. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE WITH NO DELAY. THERE WAS NO PATIENT OR USER INJURY AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210679 ↗
• MalfunctionMar 10, 2023Material Separation; Material Separation

  THE HOSPITAL REPORTED THAT DURING A PROCEDURE, AFTER THE FIRST PASS WITH AN ENDOBRONCHIAL BRUSH, THE SHEATH OF THE BRUSH DETACHED FROM THE INSTRUMENT LEAVING THE WIRE EXPOSED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE USING ANOTHER DEVICE.THERE WAS NO PROCEDURE DELAY AND THERE WAS NO HARM OR INJURY TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527086 ↗
• MalfunctionMar 10, 2023Material Separation; Material Separation

  THE COSTUMER REPORTED THAT DURING A PROCEDURE, AFTER THE SECOND PASS WITH AN ENDOBRONCHIAL BRUSH, THE SHEATH OF THE BRUSH DETACHED FROM THE INSTRUMENT LEAVING THE WIRE EXPOSED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE INTENDED PROCEDURE USING ANOTHER DEVICE. THERE WAS NO PROCEDURE DELAY AND THERE WAS NO HARM OR INJURY TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16526597 ↗
• MalfunctionMar 10, 2022Material Separation; Material Separation

  PHYSICIAN EXPERIENCED A BRUSH SHEATH DETACHING FROM THE BRUSH WHILE DEPLOYING A FIDUCIAL DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725464 ↗
• MalfunctionMar 10, 2022Material Separation; Material Separation

  PHYSICIAN EXPERIENCED A BRUSH SHEATH DETACHING FROM THE BRUSH WHILE DEPLOYING A FIDUCIAL DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13725373 ↗
• MalfunctionMar 2, 2022Material Separation; Material Separation

  PHYSICIAN EXPERIENCE A BRUSH SHEATH COMING DISCONNECTED FROM THE INNER PORTION OUT OF THE BOX. THIS HAPPENED WHEN THE BRUSH WAS DOWN IN THE SCOPE. ONCE THE BRUSH WAS EXTENDED TO PUSH OUT THE FIDUCIAL, THE SHEATH BECAME DISCONNECTED. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656843 ↗
• MalfunctionFeb 11, 2022Material Separation; Activation, Positioning or Separation Problem; Material Separation

  THE SHEATH SEPARATED AT THE HANDLE )NEXT TO THE BLACK HANDLE). WHEN THE RT TRIED TO PLACE A FIDUCIAL MARKER, THE BRUSH WAS NO LONGER ABLE TO "THROW" AND THEREFORE COULD NOT PLACE THE FIDUCIAL. PROCEDURE WAS COMPLETED. NOTE: THIS AE IS IN CONNECTION WITH THE SAME PROCEDURE AS THE 3007222345-2022-00004 AE. DURING THE PROCEDURE, TWO OF THE SAME MODEL DEVICE, WITH TWO DIFFERENT LOT NUMBERS, HAD THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515926 ↗
• MalfunctionFeb 10, 2022Material Separation

  THE SHEATH SEPARATED AT THE HANDLE (NEXT TO THE BLACK HANDLE). WHEN THE RT TRIED TO PLACE A FIDUCIAL MARKER, THE BRUSH WAS NO LONGER ABLE TO "THROW" AND THEREFORE COULD NOT PLACE THE FIDUCIAL. PROCEDURE WAS COMPLETED.

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

  MAUDE report 13509849 ↗
• MalfunctionFeb 1, 2022Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  STAFF REACHED OUT TO REPORT THAT THE SHEATH FELL OFF THE BRUSH DURING A PROCEDURE (NOT IN A PATIENT). A NEW BRUSH WAS OPENED AND THE PROCEDURE CONTINUED IMMEDIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13419090 ↗
• MalfunctionDec 8, 2021Material Separation; Insufficient Device Problem Information; Material Separation; Insufficient Device Problem Information

  ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: THERE WAS NO IMPACT ON THE PATIENT OR THE PROCEDURE. THE PROCEDURE WAS COMPLETED AFTER A 1-MINUTE DELAY TO SWITCH TO A NEW INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12964234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122106. One submission often covers many models, so check the product and lot details in each record.

• 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-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-2662-2023 · Aug 10, 2023 · Open, Classified
  Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SPiN Xtend 21ga, 1.8 OD, 5/Bx INS-5440 View Peripheral Catheter, 3.8mm OD, 2.5mm WC INS-5411 0.016
• 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-2267-2023 · May 15, 2023 · Open, Classified
  Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush, 12mm L, 1.8mm OD-Intended for use in clinical interventions and for anatomical structures where comp
• 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-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-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