ig4 System, 120V, 60Hz SYS-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00815686020088), received between Dec 3, 2019 and Nov 14, 2023 — classified as 1 death, 10 injuries.

The most frequently reported specific device problem is “Failure to Sense” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

12 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-2659-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2023Failure to Sense; Failure to Sense

  A COMPANY REPRESENTATIVE, ON BEHALF OF A CUSTOMER, REPORTED THAT THE PHYSICIAN FELT THE "REGISTRATION" OF THE VERAN SPIN SYS-3000 DID NOT FUNCTION WELL AND WAS NOT ACCURATE DURING A BIOPSY PROCEDURE, DESPITE FOLLOWING VERAN PROTOCOL. THE NAVIGATION PORTION OF THE PROCEDURE COULD NOT BE PERFORMED, AND WAS ABORTED, INCURRING A 1 HOUR DELAY WHILE THE PATIENT WAS UNDER ANESTHESIA (MIDAZOLAM). THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH FLUOROSCOPY GUIDED TRANSBRONCHIAL LUNG BIOPSY THAT SAME DAY, WHICH WAS THE FACILITIES STANDARD BACK UP PLAN. THE PATIENT OUTCOME WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18137023 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  JOURNAL ARTICLE: PERIPHERAL LUNG NODULE DIAGNOSIS AND FIDUCIAL MARKER PLACEMENT USING A NOVEL TIP-TRACKED ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY SYSTEM. PUBLISHED JANUARY 2019. BACKGROUND: ELECTROMAGNETIC NAVIGATION (EMN) HAS IMPROVED BRONCHOSCOPIC ACCESS TO PERIPHERAL PULMONARY NODULES. A NOVEL EMN SYSTEM UTILIZING NOVEL TIP-TRACKED INSTRUMENTS FOR ENDOBRONCHIAL [ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB)] AS WELL AS TRANSTHORACIC LUNG BIOPSY [ELECTROMAGNETIC-GUIDED TRANSTHORACIC NEEDLE ASPIRATION (EMTTNA)] HAS BECOME AVAILABLE. THE SYSTEM PROVIDES REAL-TIME FEEDBACK AS WELL AS THE ABILITY TO BIOPSY LESIONS OUTSIDE OF THE AIRWAY. THESE ADVANCES HAVE THE POTENTIAL TO IMPROVE DIAGNOSTIC YIELD OVER PREVIOUS EMN SYSTEMS. BASED ON THE ARTICLE, THERE WERE FOUR (4) ADVERSE EVENTS DOCUMENTED: - THERE WERE THREE (3) PATIENTS THAT DEVELOPED A PNEUMOTHORAX THAT REQUIRED SMALL-BORE CHEST TUBE PLACEMENT WITH AN OBSERVATION ADMISSION (<24 HOURS). - THERE WAS ONE (1) PATIENT THAT DEVELOPED A HEMORRHAGE THAT REQUIRED BRONCHOSCOPIC WEDGING AND ICED SALINE TO ACHIEVE HEMOSTASIS. THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. THERE WAS NO ALLEGATION OR INFORMATION TO SUGGEST THERE WAS AN ASSOCIAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 17278847 ↗
• DeathMay 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE 5TH FORCEPS PASS, SIGNIFICANT BLEEDING OCCURRED AS BLOOD (INCLUDING CLOTS) WERE BACKING UP IN PATIENTS TRACHEA AND ET TUBE. ANESTHESIA PROCEEDED WITH A DOUBLE LUMEN TUBE TO STABILIZE RIGHT LUNG BLEEDING WHILE VENTILATING THE LEFT LUNG. PATIENT ADMITTED TO ICU AS OF 4PM ON (B)(6) 2020. PATIENT HAS A HISTORY OF ASCITES AND CIRRHOSIS. UPDATED ABOUT THE OUTCOME OF THE CASE FROM PHYSICIAN ON (B)(6) 2020. THE PATIENT EXPIRED AT 1AM ON (B)(6) 2020.

  Patient problems: Blood Loss; Death

  MAUDE report 10092166 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VERAN SYSTEM WORKED AS INTENDED. PATIENT HAS HISTORY OF ADENOID CYSTIC CARCINOMA OF THE HEAD AND NECK. MULTIPLE NODULES WERE PRESENT IN BOTH LUNGS. THREE TARGETS WERE IDENTIFIED IN THE RIGHT LUNG. DR (B)(6) WAS ABLE TO NAVIGATE TO THE THREE NODULES, ONE LOCATED IN THE RIGHT UPPER LOBE AND TWO IN THE RIGHT LOWER LOBE. AFTER SAMPLING ALL THREE, HE ELECTED TO ACCESS THE RIGHT UPPER LOBE VIA SPIN PERC. AFTER PREPPING IN STERILE FASHION, HE SUCCESSFULLY ACCESSED THE NODULE AND OBTAINED 7 BIOPSIES. AFTER THE PROCEDURE, POST IMAGING FOUND A PNEUMOTHORAX AND THE PATIENT REQUIRED A CHEST TUBE.

  Patient problems: Pneumothorax

  MAUDE report 9401571 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED; NO MALFUNCTION. DOCTOR QUICKLY NAVIGATED TO THIS 5CM TARGET. HE DID USE THE EWC TO GET TO A DIFFERENT AIRWAY INSIDE THE MASS WHERE CAVITATION WAS NOT PRESENT. THEY WERE PLANNING PERC BUT EXCESSIVE BLEEDING PREVENTED IT. INSUFFICIENT INFORMATION REGARDING TREATMENT OF BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 9401570 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED; NO MALFUNCTION. DOCTOR NAVIGATED TO LEFT UPPER LOBE NODULE USING TWO FORCEPS, NEEDLE AND BRUSH. PATIENT PRESENTED WITH A PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 9401565 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON START OF NAVIGATION PATIENT WAS BLEEDING EXCESSIVELY. DOCTOR ABORTED THE REST OF THE PROCEDURE; COULDN'T STOP THE BLEEDING. LACK OF INFORMATION REGARDING THE TREATMENT FOR BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 9401563 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED; NO MALFUNCTION. THE TARGET WAS NEAR LYING BETWEEN THE DIAPHRAGM AND THE PLURAL WALL, SO WE HAVE TO BE EXTREMELY CAREFUL DURING NEEDLE PASSES. TWO PASSES WERE MADE AND TWO FORCEPS BIOPSIES. MOVED TO THE RIGHT UPPER LOBE TARGET AND TOOK ONE FORCEPS BIOPSY. X-RAY REVEALED A PNEUMOTHORAX IN THE LEFT LUNG.

  Patient problems: Pneumothorax

  MAUDE report 9401562 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SYSTEM PERFORMED AS INTENDED; NO MALFUNCTION. DOCTOR FOUND THAT EVEN WHEN WE WERE IN THE NODULE ON NAVIGATION, THERE WAS NO VISIBLE LESION IN HE AIRWAYS SO THE FORCEPS WOULD HAVE NOT YIELDED ANYTHING BUT BRONCHIAL EPITHELIAL CELL. DOCTOR THEN SWITCHED TO THE 22GA NEEDLE TO GO FOR THE TARGET OUTSIDE OF THE AIRWAY FOR A FEW SAMPLES. NOW THAT HE HAD A GENERAL IDEA OF WHERE THE NODULE WAS, HE SWITCHED OVER TO CRYO TO GET 3 SAMPLES WITH THE CRYO PROBE IN CONJUNCTION WITH AN AIRWAY BALLOON BLOCKER TO CONTROL BLEEDING. GRADE 3 BLEEDING INDICATED.

  Patient problems: Blood Loss

  MAUDE report 9401536 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MASS IN LEFT UPPER LOBE RESOLVED ALMOST COMPLETELY. THERE WAS STILL SOME GROUND GLASS LESIONS THROUGHOUT THE RIGHT LUNG. AFTER REGISTRATION, DOCTOR BRUSHED THE RIGHT UPPER LOBE QUICKLY. THE PATIENT HAD EXCESSIVE BLEEDING, AND THE CASE WAS ENDED. INSUFFICIENT INFORMATION TO DETERMINE PROCEDURE OUTCOME AND LEVEL OF TREATMENT FOR BLEEDING.

  Patient problems: Blood Loss

  MAUDE report 9401535 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DOCTOR WAS ABLE TO GET SOME ATYPICAL TISSUE THAT PATHOLOGY WAS THINKING WAS NSC. PATIENT RECEIVED A PNEUMOTHORAX.

  Patient problems: Pneumothorax

  MAUDE report 9401534 ↗

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-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-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-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-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
• 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-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-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-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