Always-On Tip Tracked 19ga ANSO Histology Needle, 12mm L, 1.8mm OD INS-0382Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00815686020590), received between Apr 22, 2022 and Jun 30, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (4 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-2265-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

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.

• MalfunctionJun 30, 2023Retraction Problem; Retraction Problem

  THE PHYSICIAN REPORTED THAT AFTER THE FIRST PASS, THE NEEDLE (INS-0382 ALWAYS-ON TIP TRACKED 19GA ANSO HISTOLOGY NEEDLE) WOULD NOT RETRACT BACK INTO THE SHEATH AFTER RETRIEVING THE SAMPLE. THE PHYSICIAN PROCEEDED WITH A NEW 19GA NEEDLE TO COMPLETE THE CASE. THE PROCEDURE WAS 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 17243098 ↗
• InjuryJun 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PHYSICIAN PERFORMED A PROCEDURE ON A PATIENT WITH A LEFT UPPER LUNG MASS ATTACHED TO THE PLEURA. HE USED A 19GA NEEDLE (INS-0382 ALWAYS-ON TIP TRACKED 19GA ANSO HISTOLOGY NEEDLE) AND A 22GA NEEDLE (INS-5410 ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE) DURING THE PROCEDURE. AFTER THE CASE, A CHEST X-RAY SHOWED THE PATIENT HAD DEVELOPED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED. THE PATIENT RECOVERED. THERE WAS NO ALLEGATION OR REPORT OF A DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT. THIS REPORT IS BEING SUBMITTED FOR THE 19GA NEEDLE. THE 22GA NEEDLE IS BEING REPORTED ON MEDWATCH REPORT 3007222345-2023-00052.

  Patient problems: Pneumothorax

  MAUDE report 17238392 ↗
• MalfunctionApr 14, 2023Retraction Problem; Retraction Problem

  THE USER FACILITY REPORTED THAT AFTER FIVE PASSES WITH THE VERAN INS-0382 ENDOBRONCHIAL NEEDLE (ALWAYS-ON TIP TRACKED 19GA ANSO HISTOLOGY NEEDLE, 15MM L, 1.8MM OD), THE 19GA NEEDLE (SUBJECT DEVICE) WOULD NOT RETRACT BACK INTO ITS SHEATH AFTER RETRIEVING THE SAMPLE. AN INS-0352 (ALWAYS-ON TIP TRACKED BRUSH, 15MM L, 1.8MM OD) WAS OPENED TO PROCEED WITH THE CASE. THERE WAS A MINOR PROCEDURE DELAY OF 1-2 MINUTES DUE TO THE REPORTED ISSUE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED IMPACT ON THE PATIENT OR THE PROCEDURE. ADDITIONAL DETAILS HAVE BEEN REQUESTED REGARDING THE REPORTED EVENT, INCLUDING PATIENT AND PROCEDURE INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748219 ↗
• MalfunctionApr 13, 2023Retraction Problem; Retraction Problem

  A VERAN PRODUCT MANAGER WAS ON-SITE DURING A BRONCHOSCOPY AND BRONCHOALVEOLAR LAVAGE (BAL) PROCEDURE AND REPORTED THAT AFTER THREE PASSES, THE INS-0382 ENDOBRONCHIAL NEEDLE (ALWAYS-ON TIP TRACKED 19GA HISTOLOGY NEEDLE, 15MM L, 1.8MM OD) WOULD NO LONGER RETRACT BACK INTO ITS SHEATH AFTER THE EXTRACTED TISSUE SAMPLE WAS PLACED IN THE COLLECTION CONTAINER. THE ISSUE DID NOT OCCUR WHILE THE NEEDLE WAS IN THE PATIENT OR IN THE BRONCHOSCOPE. A 21GA ENDOBRONCHIAL NEEDLE WAS OPENED FOR ADDITIONAL SAMPLING. A BRUSH WAS ALSO OPENED FOR CYTOLOGY SAMPLES THE PROCEDURE WAS COMPLETED. THERE WAS NO IMPACT TO THE PATIENT OR THE PROCEDURE AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16739375 ↗
• 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 15635199 ↗
• MalfunctionApr 22, 2022Retraction Problem; Insufficient Device Problem Information; Retraction Problem; Insufficient Device Problem Information

  DURING A PROCEDURE, THE PHYSICIAN REQUESTED "NEEDLE BACK." THE PHYSICIAN REMOVED THE NEEDLE, BUT IT WAS NOTED THAT THE NEEDLE WAS STILL EXTENDED. ATTEMPTS WERE MADE TO RETRACT THE NEEDLE BACK INTO THE SHEATH, AND A NURSE TRIED TO PHYSICALLY FORCE THE NEEDLE BACK, BUT IT WAS LOCKED IN THE OUT POSITION THE SCOPE WAS CHECKED FOR DAMAGE AND NO DAMAGE WAS DETECTED. THE VERAN REP IN THE PROCEDURE PLUGGED THE NEEDLE BACK INTO THE SYSTEM AFTER THE PROCEDURE AND NO ADDITIONAL COIL BREAK OR ERROR MESSAGE WAS NOTED. ONCE THE NEEDLE BREAK WAS DETECTED, THE PHYSICIAN MOVED FROM A VERAN PROCEDURE OVER TO AN EBUS PROCEDURE TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190072 ↗

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-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-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-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-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-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-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-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-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-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