Arcpoint ILS-2100-PN (UDI 10884521809505)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521809505), received between Aug 29, 2023 and Sep 16, 2026 — classified as 2 injuries, 2 malfunctions.

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 18, 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.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during the procedure, pneumothorax occurred and was reportedly likely caused by the needle advancing too far. The pneumothorax was discovered after cleanup of the case. The physician was able to complete the superDimension portion of the case. The patient had chest tube placement, and the hospitalization was extended overnight. The patient was then discharged and recovered.

  Patient problems: Pneumothorax

  MAUDE report 50793694 ↗
• MalfunctionApr 18, 2025Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, WHEN RETRACTED THE SAMPLING NEEDLE BACK INTO THE SHEATH, THE NEEDLE BROKE. THE INNER PIECE THAT THE NEEDLE IS ATTACHED TO WAS PULLED OUT COMPLETELY.

  Patient problems: Insufficient Information

  MAUDE report 21869241 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, A RETROSPECTIVE STUDY EXAMINED 200 CONSECUTIVE PATIENTS REFERRED FOR CONE BEAM CT BRONCHOSCOPIC BIOPSY OF PERIPHERAL LUNG LESIONS BETWEEN APRIL 2021 AND NOVEMBER 2021. THE COMPANY'S CATHETER WERE USED IN THE FIRST 85 PATIENTS AND A COMPETITOR DEVICE WAS USED IN THE NEXT 115 PATIENTS. THE BIOPSY APPROACH INCLUDED AN EXTENDED MULTIMODALITY APPROACH, INCLUDING IN ORDER THE FOLLOWING: FINE NEEDLE ASPIRATE FOR 8 PASSES USING THE COMPANY'S PULMONARY NEEDLE OR A COMPETITOR NEEDLE, CYTOLOGY BRUSH USING THE COMPANY'S CYTOLOGY BRUSH, TRANSBRONCHIAL FORCEPS BIOPSIES WERE PERFORMED USING THE COMPANY'S FORCEPS OR A COMPETITOR DEVICE. POSTOPERATIVE COMPLICATIONS INCLUDED PNEUMOTHORAX IN THREE PATIENTS AND BLEEDING IN ONE PATIENT. A CHEST TUBE WAS REQUIRED TO TREAT PNEUMOTHORAX IN TWO PATIENTS. THE PATIENT WITH BLEEDING DEVELOPED POSTOPERATIVE HYPOXEMIA AND REQUIRED OVER-NIGHT HOSPITALIZATION. THE PATIENT ALSO REQUIRED TOPICAL TRAXEMENIC ACID AND TOPICAL EPINEPHRINE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Hypoxia; Pneumothorax

  MAUDE report 19549116 ↗
• MalfunctionAug 29, 2023Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE INNER NEEDLE CORE BECAME DETACHED FROM OUTER SHEATH WHEN RESPIRATORY THERAPIST WAS RETRACTING THE NEEDLE. NO DEVICE FRAGMENTS DROPPED IN PATIENT CAVITY. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE BY PULLING ANOTHER NEEDLE FROM THE STOCK. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646807 ↗