Always-On Tip Tracked 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD INS-0392Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00815686020613), received between Apr 22, 2022 and Aug 8, 2023 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (6 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-2266-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2023Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE FAILED TO RETRACT. THE ISSUE OCCURRED DURING AN ENDOTRACHEAL BRONCHOSCOPY. ONE NEEDLE WAS TESTED BEFORE USE AND FAILED TO RETRACT. ANOTHER NEEDLE FROM THE SAME LOT WAS RETRIEVED, TESTED, AND USED TO GATHER TISSUE SAMPLES, BUT FAILED TO RETRACT ONCE INSIDE THE PATIENT WHEN THERE WAS NO FAILURE OUTSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT. THE USER FACILITY REPORTED THIS EVENT UNDER MEDWATCH 4200820000-2023-8005. THIS EVENT IS REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6): FIRST DEVICE (FAILED TO RETRACT PRIOR TO PATIENT INSERTION); (B)(6): SECOND DEVICE (FAILED TO RETRACT WHILE INSIDE THE PATIENT). THIS MEDICAL DEVICE REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484692 ↗
• MalfunctionAug 8, 2023Retraction Problem; Retraction Problem

  THE CUSTOMER REPORTED TO OLYMPUS THE ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE FAILED TO RETRACT. THE ISSUE OCCURRED DURING AN ENDOTRACHEAL BRONCHOSCOPY. ONE NEEDLE WAS TESTED BEFORE USE AND FAILED TO RETRACT. ANOTHER NEEDLE FROM THE SAME LOT WAS RETRIEVED, TESTED, AND USED TO GATHER TISSUE SAMPLES, BUT FAILED TO RETRACT ONCE INSIDE THE PATIENT WHEN THERE WAS NO FAILURE OUTSIDE THE PATIENT. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT. THE USER FACILITY REPORTED THIS EVENT UNDER MEDWATCH 4200820000-2023-8005. THIS EVENT IS REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6): FIRST DEVICE (FAILED TO RETRACT PRIOR TO PATIENT INSERTION); (B)(6): SECOND DEVICE (FAILED TO RETRACT WHILE INSIDE THE PATIENT). THIS MEDICAL DEVICE REPORT IS FOR PATIENT IDENTIFIER C23319357.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484466 ↗
• MalfunctionJun 30, 2023Retraction Problem; Retraction Problem

  THE PHYSICIAN REPORTED THE HUB AND SUCTION ADAPTER OF THE 21GA NEEDLE (INS-0392 ALWAYS-ON TIP TRACKED 21GA ANSO CYTOLOGY NEEDLE) WAS DEFECTIVE AND NOT FULLY CLOSING. A NEW NEEDLE WAS OPENED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH NO DELAY. THERE WAS NO INJURY TO THE PATIENT OR USER AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243629 ↗
• MalfunctionMar 23, 2023Retraction Problem; Retraction Problem

  MEDWATCH REPORT (MW5114915) WAS RECEIVED FROM THE FDA ON 21-FEB-2023. THE MEDWATCH REPORT WAS SUBMITTED BY A RISK MANAGER AT THE USER FACILITY. THE FOLLOWING DESCRIPTION WAS INCLUDED IN THE REPORT. "DURING A NAVIGATIONAL BRONCHOSCOPY WITH THE VERAN THERE WAS AN ISSUE WITH THE ALWAYS-ON TIP TRACKED 21G ANSO CYTOLOGY NEEDLE. THE NEEDLE ON THE PRODUCT WOULD NOT RETRACT BACK INTO THE SHEATH AFTER A FEW USES. THIS MALFUNCTION RESULTED IN DISCONTINUED USE OF THE PRODUCT AND LIMITED SPECIMENS." BASED ON THE INFORMATION PROVIDED IN THE MEDWATCH REPORT SUBMITTED BY THE RISK MANAGER, THERE WAS NO IMPACT ON THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607064 ↗
• MalfunctionSep 14, 2022Retraction Problem; Retraction Problem

  21GA NEEDLE WOULD NOT RETRACT BACK INTO SHEATH DURING PROCEDURE SET UP AND PRIOR TO INSERTION INTO THE SCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422498 ↗
• MalfunctionSep 14, 2022Retraction Problem; Retraction Problem

  21GA NEEDLE WAS FULLY EXTENDED OUT OF THE PACKAGING AND WOULD NOT RETRACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422493 ↗
• InjuryApr 22, 2022Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  VERAN VSUPPORT WAS MADE AWARE ON 01-OCT-2021 OF A RESEARCH ARTICLE PUBLISHED IN "LUNG." THE TITLE OF THE RESEARCH ARTICLE IS: 4D ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY FOR THE SAMPLE OF PULMONARY LESIONS: FIRST EUROPEAN REAL-LIFE EXPERIENCE. THE ARTICLE MENTIONS USING THE VERAN SPIN THORACIC NAVIGATION SYSTEM AND TWO OF THE VERN INSTRUMENTS: FORCEPS AND 21 GA NEEDLE. THE ARTICLE STATES THAT THERE WAS ONE INCIDENCE OF PNEUMOTHORAX WHILE USING THE VERAN SPIN NAVIGATION SYSTEM. NO ADDITIONAL INFORMATION WAS GIVEN IN THE ARTICLE.

  Patient problems: Pneumothorax

  MAUDE report 14190179 ↗

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-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-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-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-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-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-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
• 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