SPiN Xtend 2.0mm OD, 21ga INS-5450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815686020651), received between Dec 19, 2019 and Jun 30, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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-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-2269-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2023Break; Break

  A VERAN REPRESENTATIVE WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. THEY USED A SPIN EXTEND NEEDLE FOR A PROCEDURE, AND THE STYLET BROKE AFTER THE FIRST PASS. ANOTHER SPIN XTEND WAS OPENED TO CONTINUE WITH THE PROCEDURE. THE INTENDED 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 17243512 ↗
• InjuryApr 13, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  DURING POST-PROCEDURE XRA, THE COIL FROM THE END OF THE SPIN XTEND NEEDLE WAS FOUND IN THE PATIENT'S AIRWAY. THE PATIENT HAD TO HAVE AN ADDITIONAL PROCEDURE TO REMOVE THE COIL.

  Patient problems: Airway Obstruction; Foreign Body In Patient

  MAUDE report 11655966 ↗
• MalfunctionNov 8, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT IS A (B)(6) MALE WEIGHING (B)(6) WITH NO RELEVANT PREEXISTING CONDITIONS. PHYSICIAN MADE 3 PASSES WITH THE SPIN XTEND NEEDLE. BEFORE INSERTING THE NEEDLE INTO THE SCOPE ON THE 4TH PASS, PHYSICIAN NOTICED A PIECE OF METAL STICKING OUT OF THE DISTAL END, JUST BARELY PASSED THE SHEATH. I CAME AROUND TO INSPECT. WE DEPLOYED THE NEEDLE, WHILE OUTSIDE OF THE PATIENT, TO TEST IT AND THE METAL PIECE REMAINED STATIONARY. I SUGGESTED WE COULD REPLACE IT, BUT PHYSICIAN WENT FORWARD WITH THE SAME NEEDLE FOR A 4TH PASS. PHYSICIAN COMPLETED HIS 4TH PASS BUT WHEN HE REMOVED THE NEEDLE FROM THE SCOPE, HE NOTICED THE METAL PIECE WAS NOT STICKING OUT ANYMORE. HE IMMEDIATELY ASKED FOR A THERAPEUTIC SCOPE AND CONVENTIONAL FORCEPS, WHERE HE DISCOVERED THE METAL PIECE WAS INSIDE THE TRACHEAL TUBE. HE SUCCESSFULLY REMOVED IT WITH THE FORCEPS AND MOVED ON TO EBUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10806667 ↗
• MalfunctionDec 19, 2019Break

  AFTER TAKING MULTIPLE BIOPSIES WITH THE SPIN XTEND NEEDLE IT APPEARED THAT A PART OF THE SPIN XTEND NEEDLE BROKE OFF, AND WAS LYING IN THE PATIENT'S AIRWAY. THE DOCTOR IMMEDIATELY PULLED THE SPIN XTEND NEEDLE OUT OF THE BRONCHOSCOPE, AND EASILY RETRIEVED THE PIECE LYING INSIDE THE PATIENTS AIRWAY. AFTER THE PIECE WAS OUT OF THE PATIENT, THE DOCTOR DECIDED THAT WE HAD SUFFICIENT TISSUE, AND ENDED THE CASE. UPON FURTHER INVESTIGATION OF THE INSTRUMENT, IT SEEMED THAT THE PIECE SURROUNDING THE NEEDLE INSIDE THE SHEATH WAS SOMEHOW DISLODGED AND ENDED UP IN THE PATIENT. THE REPRESENTATIVE IMMEDIATELY PACKAGED THE INSTRUMENT, AND THE BROKEN PIECE SO IT CAN BE SHIPPED BACK TO THE OFFICE FOR FURTHER INSPECTION. AFTER SPEAKING WITH THE DOCTOR, HE SAID THE PATIENT WAS DOING FINE, AND THAT THERE WAS ABNORMAL ISSUES SURROUNDING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 9496787 ↗

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-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-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-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-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-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-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-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-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
• 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