SPiNDrive Software Application SFT-0007Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00815686021078), received between Mar 15, 2022 and Mar 15, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2022Connection Problem

  WITH A PATIENT UNDER ANESTHESIA, AND DUE TO A CONNECTIVITY ISSUE, THE PROCEDURE WAS ABORTED.

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

  MAUDE report 13770727 ↗

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-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-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-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-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-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-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-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-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-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