Always-On Tip Tracked 22ga SPiN Flex Needle, 12mm L, 1.8mm OD INS-5410Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00815686020637), received between Oct 19, 2020 and Oct 2, 2023 — classified as 9 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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

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-2268-2023 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT AFTER MAKING SEVERAL PASSES THROUGH NAVIGATION AND OBTAINING TISSUE SAMPLES WITH THE INS-5410 (ALWAYS-ON TIP TRACKED 22GA SPIN FLEX NEEDLE, 12MM L, 1.8MM OD), THE ERROR MESSAGE "INSTRUMENT OUTSIDE OF TRACKING EM" STARTED TO FLICKER ON AND OFF THE SCREEN EVEN THOUGH THE INSTRUMENT WAS INSIDE THE PATIENT'S LUNGS AND THE FIELD GENERATOR WAS PLACED PROPERLY OVER THE PATIENT'S CHEST. THE DOCTOR OPENED A NEW INS-5410 TO CONTINUE WITH THE CASE. THE CASE WAS SUCCESSFULLY COMPLETED. THE PATIENT DEVELOPED A PNEUMOTHORAX THAT WAS FOUND IMMEDIATELY AFTER THE PROCEDURE VIA A CHEST CT. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. THE PNEUMOTHORAX RESOLVED WITHOUT A CHEST TUBE BEING PLACED. THE PATIENT WAS REPORTEDLY DISCHARGED THE FOLLOWING DAY. THE PHYSICIAN BELIEVED BECAUSE THE NEEDLE'S TRACKING WAS SPOTTY, IT COULD HAVE BEEN A CONTRIBUTING FACTOR TO THE PNEUMOTHORAX. THIS REPORT IS BEING SUBMITTED FOR THE PNEUMOTHORAX. PATIENT DEMOGRAPHICS WERE REQUESTED BUT NOT PROVIDED.

  Patient problems: Pneumothorax

  MAUDE report 17854706 ↗
• MalfunctionJun 30, 2023Retraction Problem; Retraction Problem

  A VERAN REPRESENTATIVE WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. A 22GA NEEDLE (INS-5410 ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE) BROKE DURING THE CASE AND A NEW ONE WAS OPENED. THE BREAK WAS NOTICED WHEN TRYING TO GET SAMPLES OUT OF THE NEEDLE. THE NEEDLE WOULD PUSH OUT BUT NOT RETRACT. THEY WERE WORKING IN THE UPPER LOBE OF THE LUNG AND THE PHYSICIAN STATED THAT IT WASN'T EASY TO PULL THE NEEDLE OUT. THE NEEDLE WAS INSIDE THE SHEATH AFTER TAKING THE FIRST SAMPLES. THE VERAN REPRESENTATIVE THOUGHT THE NEEDLE BROKE WHEN THE PHYSICIAN PULLED THE NEEDLE OUT OF THE WORKING CHANNEL. THE INTENDED PROCEDURE WAS 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 17243670 ↗
• MalfunctionJun 30, 2023Retraction Problem; Retraction Problem

  THE PHYSICIAN REPORTED THEY EXPERIENCED A 22GA NEEDLE (INS-5410 ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE) NOT RETRACTING BACK INTO THE SHEATH AFTER IT WAS EXTRACTED TO COLLECT A SAMPLE. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO INJURY TO THE PATIENT OR USER DUE TO THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243538 ↗
• MalfunctionJun 30, 2023Break; Break

  A VERAN REPRESENTATIVE WAS ON-SITE WHEN THE FOLLOWING EVENT OCCURRED. WHEN ATTEMPTING TO UNCLOG THE 22GA NEEDLE (INS-5410 ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE) USING A STYLET (INS-5411 0.016" STYLET, 1235MM L), THE STYLET BROKE OFF LEAVING HALF THE STYLET STILL IN THE CHANNEL OF THE NEEDLE, MAKING THE 22GA NEEDLE INEFFECTIVE FOR FURTHER USE. A NEW 22GA NEEDLE WAS OPENED TO PROCEED. THE PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO INJURY TO THE PATIENT OR USER AS A RESULT OF THE REPORTED ISSUE. THIS REPORT IS BEING SUBMITTED FOR THE 22GA NEEDLE (INS-5410). THE STYLET (INS-5411) IS BEING REPORTED ON MEDWATCH 3007222345-2023-00070.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17243403 ↗
• MalfunctionJun 30, 2023Break; Break

  A VERAN REPRESENTATIVE REPORTED THE FOLLOWING EVENT ON BEHALF OF THE FACILITY. A 22GA NEEDLE BROKE APART AT THE LOCKING MECHANISM AFTER THREE (3) PASSES. THE PHYSICIAN FELT HE HAD GOTTEN ENOUGH SAMPLES AT THIS POINT SO HE DECIDED TO COMPLETE THE CASE. THERE WAS NO PATIENT OR USER INJURY DUE TO THE REPORTED ISSUE. THERE WAS NO IMPACT ON THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17242521 ↗
• MalfunctionJun 30, 2023Retraction Problem; Retraction Problem

  THE PHYSICIAN REPORTED THAT AFTER SAMPLING, THE NEEDLE WOULD NOT RETRACT BACK INTO THE SHEATH OF THE INSTRUMENT. THE PHYSICIAN DID NOT OPEN A NEW INSTRUMENT AND FINISHED THE INTENDED PROCEDURE WITH NO DELAY. THERE WAS NO PATIENT OR USER HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238526 ↗
• 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 22GA NEEDLE. THE 19GA NEEDLE IS BEING REPORTED ON MEDWATCH REPORT 3007222345-2023-00051.

  Patient problems: Pneumothorax

  MAUDE report 17238472 ↗
• MalfunctionJun 29, 2023Retraction Problem; Retraction Problem

  THE PHYSICIAN REPORTED THAT ON THE FIRST PASS AND AFTER NAVIGATING FOR ABOUT 15 MINUTES, THE STAFF WAS UNABLE TO RETRACT THE NEEDLE (INS-5410 ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE, 15MM L, 1.8MM OD) FULLY INTO THE SHEATH AFTER RETRIEVING THE SAMPLE. THE STAFF CUT OFF THE TIP OF THE NEEDLE FOR PATHOLOGY. THE PHYSICIAN PROCEEDED TO COMPLETE THE PROCEDURE WITH AN ALTERNATE INSTRUMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO INJURY TO THE PATIENT OR USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17231475 ↗
• MalfunctionJun 28, 2023Retraction Problem; Retraction Problem

  THE PHYSICIAN REPORTED THAT AFTER SAMPLING, THE INS-5410 (ALWAYS-ON TIP TRACKED 22GA ANSO FLEXIBLE NEEDLE, 15MM L, 1.8MM OD) WOULD NOT RETRACT BACK INTO THE SHEATH OF THE INSTRUMENT. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED WITH NO DELAY. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17221627 ↗
• InjuryFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  DURING A TISSUE SAMPLING PROCEDURE, A 22GA NEEDLE WAS USED INSIDE A SPIN ACCESS CATHETER (90 DEGREE). A COIL BREAK OF THE 22GA NEEDLE OCCURRED WHILE USING THE NEEDLE INSIDE THE SPIN ACCESS CATHETER. NO SAMPLES WERE TAKEN BEFORE THE COIL BREAK. A 2-MINUTE DELAY OF THE PROCEDURE WAS REPORTED. THE FORCEPS WERE USED TO OBTAIN SAMPLES. AFTER THE PROCEDURE, THE PATIENT HAD A SMALL PNEUMOTHORAX. AS A PRECAUTION, THE CLINICIAN PLACED A CHEST TUBE. THE CLINICIAN COULD NOT DETERMINE WHETHER OR NOT IT WAS ASSOCIATED WITH THE 22 GA NEEDLE. THE NEEDLE MAY HAVE BEEN EXTENDED FOR A SHORT PERIOD OF TIME DURING THE PROCEDURE, HOWEVER IT WAS NOT USED TO OBTAIN TISSUE SAMPLES.

  Patient problems: Pneumothorax

  MAUDE report 16396725 ↗
• MalfunctionSep 14, 2022Material Separation; Material Separation

  DOCTOR WAS NAVIGATING TO HER SECOND TARGET AFTER TAKING 10 PASSES TO TARGET 1 WITH THE NEEDLE. SHE NOTICED ON HER SCOPE VIEW THAT THE NEEDLE WAS COMING OUT OF THE DISTAL END OF THE SHEATH WHILE THE TECH HAD IT RETRACTED AND IN THE LOCKED POSITION. AFTER THEY REMOVED THE INSTRUMENT FROM THE SCOPE, THEY COULD SEE THAT THE NEEDLE WAS DETACHED FROM THE POLE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422574 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD PREEXISTING HEART ISSUES AND PREVIOUS HEART ATTACK; CARDIOLOGY HAD CLEARED HER FOR THE PROCEDURE. PATIENT WAS IN PRONE POSITION AND THE DR NAVIGATED OUT TO LESION WITH FORCEPS. THE DR SWITCHED OVER TO 22G NEEDLE, TOOK ONE SAMPLE, AND THE PATIENT STARTED BLEEDING. THE DR WAS ABLE TO GET THE BLEEDING UNDER CONTROL BUT THE PRESSURE DROPPED AND THEN PATIENT CODED. THE PATIENT SUFFERED A HEART ATTACK AND WAS STABILIZED IN ROOM. THE PATIENT WAS TRANSPORTED TO CCU AND WAS RELEASED FROM THE HOSPITAL DAYS LATER.

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14605112 ↗
• InjuryApr 22, 2022Break

  DOCTOR NOTIFIED VERAN REPRESENTATIVE ON (B)(6) 2021 THAT DURING A PROCEDURE ON (B)(6) 2021 THAT THE TIP OF A 22GA NEEDLE HAD BROKEN OFF IN A PATIENT. THE SURGEON AND STAFF DID NOT NOTICE THE BROKEN NEEDLE AT THE TIME OF THE PROCEDURE. THE PROCEDURE BEING PERFORMED WAS A LUNG BIOPSY OF A LUL MEDIAL MASS. THE SURGEON STATED THAT HE DID NOT FEEL ANYTHING OR NOTICED ANY ISSUES DURING THE PROCEDURE. THE PATIENT WAS DIAGNOSED WITH CANCER FROM THE BIOPSY AND WAS REFERRED TO A THORACIC SURGEON TO GET THE MASS REMOVED. THE THORACIC SURGEON PERFORMED AN X-RAY AND NOTICED THE NEEDLE TIP IN THE LUNG. AT THIS TIME, THE PATIENT NOTED THAT THEY HAD A PERSISTENT COUGH AND CHEST PAIN THAT THEY HADN'T REPORTED TO THEIR PHYSICIAN YET, THE THORACIC SURGEON WAS ABLE TO REMOVE THE NEEDLE TIP ON (B)(6) 2021. PATIENT RECOVERED AND WAS DISCHARGED.

  Patient problems: Chest Pain; Cough; Foreign Body In Patient

  MAUDE report 14190405 ↗
• InjuryFeb 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) MALE PATIENT, WITH A HISTORY OF COPD WAS HAVING A BIOPSY PERFORMED ON A LARGE TARGET IN THE LLL. AFTER THE PROCEDURE, THE PATIENT WAS SCANNED AND A PNEUMOTHORAX WAS NOTED. A CHEST TUBE WAS PLACE AND THE PATIENT WAS SENT HOME ON (B)(6) 2021. THE PATIENT RETURNED THE NET DAY TO HAVE THE CHEST TUBE REMOVED. PATIENT RECOVERED AND WAS DISCHARGED. THE BIOPSY SAMPLES INDICATE THE PATIENT HAS ADENOCARCINOMA. THE DOCTOR USED INS-5410, FLEX NEEDLE, AND INS-5300, TRIPLE NEEDLE BRUSH, TO TAKE THE BIOPSY SAMPLE. SINCE BOTH DEVICES WERE USED TO TAKE THE SAMPLE, THE DECISION WAS MADE TO REPORT THIS UNDER THE INS-5410, SINCE THERE IS NO WAY TO DEDUCE WHICH DEVICE WAS AT FAULT. NOTE- THIS REPORT WAS ORIGINALLY SUBMITTED ON (B)(6) 2021. A PREVIOUS EMPLOYEE, CHRISTINE HARDIN, SUBMITTED ON HER ACCOUNT AND DID NOT REALIZE THAT THE REPORT WAS SENT BACK WITH AN ERROR. THIS ERROR OCCURRED DUE TO AN INCORRECT REPORT NUMBER USED. THE REPORT NUMBER WAS PUT IN THE WRONG LOCATION (UF IMPORTER REPORT # INSTEAD OF MFR REPORT. THESE ERRORS HAVE BEEN CORRECTED FOR THIS REPORT AND ALL INFORMATION CONTAINED IN THIS REPORT IS ACCURATE AT THE TIME OF THIS SUBMISSION ON FEBRUARY 10, 2022. THE ORIGINAL REPORT AND

  Patient problems: Laceration(s); Pneumothorax

  MAUDE report 13623235 ↗
• InjuryJan 12, 2022Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 13239961 ↗
• MalfunctionDec 2, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  22GA NEEDLE BROKE AT THE PROXIMAL END OF THE NEEDLE BY THE LOCKING MECHANISM. AFTER THE SECOND PASS, THAT PORTION OF THE NEEDLE BROKE. AN ADDITIONAL 22GA NEEDLE WAS OPENED, SAMPLES WERE COLLECTED, AND PROCEDURE WAS COMPLETE. DOCTOR WAS ABLE TO CONFIRM ALL BROKEN PIECES WERE COLLECTED AND PROCEDURE COMPLETE. NO PATIENT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919464 ↗
• MalfunctionDec 2, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  WHEN THE NEEDLE WAS EXTENDED OUT OF THE SHEATH, A BREAK WAS NOTICED BY THE STAFF. IT LOOKS LIKE THE NEEDLE HAD BROKEN INSIDE OF THE PLASTIC CASING THE PASTIC NEAR THE LUER LOCK CONNECTION POINT LOOKED CLOUDY AS WELL. THE DEVICE AS NOT USED DURING THE CASE OR IN THE PATIENT. ISSUE WAS NOTICED BEFORE CASE BEGAN. ANOTHER 22GA NEEDLE WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12919061 ↗
• MalfunctionJul 16, 2021Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

  ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT: AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, THEY VISUALIZED THE DEVICE SNAPPED AT THE MORE PROXIMAL END, WHICH WAS APPROXIMATELY 2-3CM FROM THE END OF THE NEEDLE. THERE WAS NO HARM OR INJURY TO THE PATIENT OR USER OF THE DEVICE. THERE WAS A MINOR DELAY WHEN OPENING A 19GA NEEDLE TO PROCEED WITH THE CASE. THE NEEDLE WAS REPORTEDLY STILL IN ONE PIECE WHEN IT WAS REMOVED FROM THE PATIENT.

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

  MAUDE report 12186013 ↗
• InjuryApr 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLARIFICATION REGARDING THE REPORTED EVENT: THE PATIENT DEVELOPED A PNEUMOTHORAX THAT REQUIRED PLACEMENT OF A CHEST TUBE. GRADE WAS 100% PNEUMOTHORAX WITH TENSION.

  Patient problems: Airway Obstruction; Cough; Pneumothorax

  MAUDE report 11721779 ↗
• InjuryOct 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS A (B)(6) MALE. PHYSICIAN USED THE FORCEPS TO REGISTER AND NAVIGATE OUT TO THE TARGET (RLL). THREE SAMPLES WERE THEN TAKEN WITH THE FORCEPS. THREE SAMPLES WERE ALSO TAKEN WITH THE 22G NEEDLE AND THE AOTT BRUSH. AFTER SAMPLING, PHYSICIAN FINISHED THE PROCEDURE WITH A BAL. AFTERWARD, A POTABLE CHEST X-RAY REVEALED THE PRESENCE OF A PNEUMOTHORAX. A SMALL, RIGHT-SIDED CHEST TUBE WAS PLACED, AND THE PATIENT IS IN STABLE CONDITION. THE PATIENT IS EXPECTED TO MAKE A FULL RECOVERY AND WAS DISMISSED FROM THE HOSPITAL ON (B)(6) 2020.

  Patient problems: Pneumothorax

  MAUDE report 10698068 ↗