Arcpoint ILS-1800-PN (UDI 10884521809499)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521809499), received between Sep 30, 2022 and Sep 23, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2024Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE BROKE OFF INSIDE THE PATIENT. IT WAS LOOSE IN THE PATIENT AND WAS REMOVED WITH FORCEPS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287260 ↗
• InjurySep 30, 2022Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING A ROBOT NAVIGATIONAL BRONCHOSCOPY FNA'S (FINE NEEDLE ASPIRATIONS) WERE BEING OBTAINED FROM A PULMONARY LESION. THE TIP, NEEDLE PORTION, OF THE 18G PULMONARY NEEDLE BROKE FREE FROM THE REST OF THE NEEDLE AND REMAINED IN THE LUNG. IT IS ROUGHLY 3/8 INCHES LONG AND WAS IMMEDIATELY VISUALIZED UNDER FLUOROSCOPY. THE DOCTORS MENTIONED  A POP WAS FELT WHILE DOING THE BIOPSY WHEN THE NEEDLE SEPARATED.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 15519888 ↗