SPiNPlanning Software Application SFT-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00815686021085), received between Aug 17, 2020 and Jun 7, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Blocked Connection” (1 report).

13 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. How this data works · Data updated Oct 13, 2026.

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.

• InjuryJun 7, 2023Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  A VERAN RESPIRATORY TERRITORY MANAGER WAS ON-SITE DURING THE FOLLOWING EVENT. THE PATIENT WAS SCANNED ON A NEW COMPUTED TOMOGRAPHY (CT) SCANNER THAT DID NOT HAVE THE VERAN PROTOCOL PROPERLY SET UP. THIS WAS NOT REALIZED UNTIL THE START OF THE CASE WHEN THE CT IMAGES WERE LOADED ONTO THE PLANNING STATION VIA A COMPACT DISC (CD). THE SLICE THICKNESS WAS TOO HIGH, AND THE SCANS HAD RED CAUTION SYMBOLS. THE PHYSICIAN WAS UNABLE TO PROCEED WITH PLANNING DUE TO THE SCANS NOT BEING PERFORMED WITH THE VERAN CT PROTOCOL. THE PATIENT WAS ALREADY UNDER ANESTHESIA. THE SITE RE-SCANNED THE PATIENT WITH THE CORRECT PROTOCOL, THEN THE PHYSICIAN PROCEEDED WITH PLANNING AS NORMAL. THE PLAN WAS SUCCESSFULLY EXPORTED, AND THE CASE WAS COMPLETED. TISSUE SAMPLES WERE ABLE TO BE OBTAINED FOR PATHOLOGY. THERE WAS REPORTEDLY A 30-MINUTE DELAY DUE TO THE ISSUE. THERE WAS NO INJURY TO THE PATIENT. THERE WAS NO MALFUNCTION OF ANY VERAN DEVICE. ALTHOUGH THERE WAS NO IMPACT ON THE PATIENT, THIS REPORT IS BEING SUBMITTED DUE TO THE 30-MINUTE PROCEDURE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084222 ↗
• InjuryJun 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE PHYSICIAN CALLED IN TO VERAN TECHNICAL SUPPORT (VSUPPORT) FOR TROUBLESHOOTING BECAUSE HE WAS HAVING ISSUES EXPORTING THE PLAN FROM THE LAPTOP TO THE TOWER OF THE SYS-3000. VSUPPORT WAS ABLE TO REMOTE INTO THE PLANNING STATION. THE PHYSICIAN WAS TRYING TO EXPORT THE PLAN VIA VERAN USB. WHEN THE EXPORT PAGE APPEARED, IT WOULD BEGIN TO EXPORT AND THEN STOP AT 66% AND AN ERROR MESSAGE, "THERE WAS AN ERROR ARCHIVING THE DATA. PLEASE RE-INSERT THE DRIVE AND TRY AGAIN" APPEARED. TROUBLESHOOTING WAS PERFORMED, WHICH WAS UNSUCCESSFUL. VSUPPORT THEN ATTEMPTED TO TRANSFER THE INFORMATION VIA SPINLINK, BUT SPINLINK CONTINUED TO RECEIVE A YELLOW CAUTION SYMBOL INSTEAD OF A GREEN ONE. VARIOUS TROUBLESHOOTING STEPS WERE PERFORMED. ALL ATTEMPTS TO EXPORT WERE MADE WITH THE VERAN USB AND A USB THE SITE HAD, BOTH RECEIVED THE ERROR MESSAGE AND STOPPED LOADING AT 66%. AFTER ASKING THE PHYSICIAN IF USB TRANSFER IS ALLOWED AT THIS SITE, HE SAID "THIS IS HOW WE NORMALLY DO IT BUT IT IS ALWAYS MESSING WITH THE COMPUTER AND MAY HAVE PUT A BLOCK ON THE USB TRANSFER". THE PROCEDURE WAS SCHEDULED AS A DAVINCI RIGHT UPPER LOBE (RUL) WEDGE RESECTION WITH NAVIGATIONAL MARKING OF THE RUL LUNG LESION WITH DYE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17057228 ↗
• InjuryApr 28, 2023Blocked Connection; Blocked Connection

  A VERAN RESPIRATORY TERRITORY MANAGER WAS ON-SITE AT THE USER FACILITY AND REPORTED THE FOLLOWING EVENT. THE COMPUTED TOMOGRAPHY (CT) IMAGES WERE UNABLE TO TRANSFER OVER TO THE SPIN PLANNING LAPTOP THAT WAS ON THE HOSPITAL'S DOMAIN. VERAN TECHNICAL SUPPORT (VSUPPORT) ASSISTED WITH CONFIRMING THE CORRECT APPLICATION ENTITY (AE) TITLE AND WENT BEHIND THE SOFTWARE UNDER FIREWALLS AND CONFIRMED THAT PRIVATE, PUBLIC, AND DOMAIN WERE SELECTED FOR PLANNING AND SPIN. VSUPPORT WAS UNABLE TO ADJUST THE WINDOWS DEFENDER FIREWALL SETTING ON OR OFF BECAUSE "THE SETTINGS ARE BEING MANAGED BY VENDER APPLICATION TRELLIX ENDPOINT SECURITY FIREWALL". THE PLANNING LAPTOP WAS POWERED OFF AND BACK ON AFTER THE CHANGES WERE MADE. THE CT IMAGES WERE STILL UNABLE TO BE TRANSFERRED TO THE PLANNING LAPTOP. AS THE CT IMAGES WERE UNABLE TO TRANSFER OVER TO THE SPIN PLANNING LAPTOP, THE PROCEDURE WAS CONVERTED TO AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) AND RADIAL EBUS, RATHER THAN USING THE VERAN SPIN THORACIC NAVIGATION SYSTEM. THE CONVERSION OF THE PROCEDURE FROM PERIPHERAL BRONCHOSCOPY WITH ELECTROMAGNETIC NAVIGATION TO AN EBUS WOULD RESULT IN SIGNIFICANT ADDITIONAL TIME UNDER ANESTHESIA. THIS REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16834770 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020: PHYSICIAN SCHEDULED A PATIENT FOR NAVIGATIONAL BRONCHOSCOPY W/ EBUS. PATIENT RECEIVED SAME DAY CT SCAN, AND CD WAS BURNED TO BE IMPORTED INTO PLANNING STATION. WHILE IMPORTING DATA THE PHYSICIAN REVIEWED CT ON ISIGHT DESKTOP AT HOSPITAL. WHILE WAITING FOR DISK TO FINISH BURNING, PATIENT WAS BROUGHT INTO PROCEDURE ROOM, AND AT THIS TIME IT HAD BEEN 20 MINUTES OF WAITING FOR IT TO LOAD SO THE VERAN REPRESENTATIVE WALKED AROUND THE CORNER TO CT TO CONFIRM THAT THEY DID NOT INCLUDE SCOUT SCANS ON DISK AS WE HAD INSTRUCTED. AS IT TURNED OUT, THE TECH HAD INCLUDED SCOUTS, AND PROCEEDED TO QUICKLY BURN A NEW DISK. WHEN THE VERAN REPRESENTATIVE BROUGHT THE DISK TO ROOM THE ANESTHESIOLOGIST WAS GIVING THE PATIENT NITROUS OXIDE TO BEGIN THE ANESTHETIC FOR THE PROCEDURE. THE VERAN REPRESENTATIVE QUICKLY CANCELLED THE PLAN THAT HAD STILL NOT UPLOADED AND TOLD THE PHYSICIAN HEI WAS HOPEFUL THIS NEW DISK WOULD LOAD IN 10-15 MINUTES. THE DISK TOOK 10 MORE MINUTES TO LOAD, THEN ONCE CLICKING THROUGH THE CARINA SELECTION SCREEN, THE SOFTWARE CRASHED. IT WOULD NOT ALLOW US TO REOPEN PLANNING, AND THE PHYSICIAN SAID HE WOULD LIKE TO CANCEL THE PROCEDURE AND EBUS AND COMPLETE THEM ON (B)(

  Patient problems: Missing Value Reason

  MAUDE report 10418046 ↗

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-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-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-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-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-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
• 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-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-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