Arcpoint ILS-2100-PN (UDI 10884521723610)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521723610), received between Jan 28, 2020 and Dec 8, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD PNEUMOTHORAX MID PROCEDURE. IT WAS NOTED THAT THE BIOPSY NEEDLE PUNCTURED THE PLEURA. TO RESOLVE THE ISSUE, A CHEST TUBE WAS PLACED. THE PHYSICIAN WAS STILL ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. IT WAS NOTED THAT THE PATIENT'S HOSPITALIZATION WAS EXTENDED.

  Patient problems: Pneumothorax

  MAUDE report 18294230 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO LITERATURE SOURCE OF COHORT STUDY, IN THE FIRST SIX MONTHS, THE AUTHORS COMPARED THE DIAGNOTIC YIELD OF TWO PLATFORMS, DIGITAL TOMOSYNTHESIS-ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (DT-ENB) AND SHAPE-SENSING ROBOTIC-ASSISTED BRONCHOSCOPY (SSRAB). SSRAB WAS USED TO BIOPSY 143 PPLS IN 133 PATIENTS AND DT-ENB WAS USED TO BIOPSY 197 PPLS IN 170 PATIENTS. TRANSBRONCHIAL NEEDLE ASPIRATION WAS THE Q9 INITIAL BIOPSY METHOD IN ALL PATIENTS USING THE 21-GAUGE PULMONARY NEEDLE IN DT-ENB PROCEDURES AND 19-GAUGE, 21-GAUGE, OR 23-GAUGE NEEDLES FROM ANOTHER MANUFACTURER IN SSRAB PROCEDURES. POST OPERATIVE COMPLICATIONS WAS PNEUMOTHORAX ON TWO (2) PATIENTS  (1.5%) OF SSRAB AND ON THREE PATIENTS (1.8%) OF DT-ENB. ONE PATIENT (0.6%) IN THE DTENB GROUP AND 2 PATIENTS (1.5%) IN THE SSRAB GROUP REQUIRED TUBE THORACOSTOMY. NO PATIENTS REQUIRED ADDITIONAL INTERVENTION BECAUSE OF BLEEDING IN EITHER COHORT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information; Pneumothorax

  MAUDE report 16746938 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE, THE STUDY WAS ABOUT THE EXPERIENCE OF ULTRATHIN PROBE TRANSBRONCHIAL LUNG CRYOBIOPSY (UP-TBLC) VIA THE MONARCH ROBOTIC-ASSISTED BRONCHOSCOPY (RAB) SYSTEM FOR THE DIAGNOSIS OF PPLS WITH PRIMARY ENDPOINTS OF SAFETY AND FEASIBILITY. THIS WAS A RETROSPECTIVE REVIEW OF 58 LESIONS IN 53 PATIENTS THAT UNDERWENT RAB WITH RADIAL PROBE ENDOBRONCHIAL ULTRASONOGRAPHY (RP-EBUS) GUIDED UP-TBLC, COMPLIMENTING TRADITIONAL SAMPLING METHODS OF PPLS DURING SINGLE USER¿S FIRST ADOPTION OF RAB BETWEEN (B)(6) 2022 AND (B)(6) 2022. UNDER GENERAL ANESTHESIA VIA AN ENDOTRACHEAL TUBE, MONARCH, RAB WITH RP-EBUS LESION CONFIRMATION WAS PERFORMED. TISSUE ACQUISITION WAS OBTAINED FOR ALL LESIONS IN THE FOLLOWING SEQUENCE: 21 GAUGE NEEDLE BIOPSY AND 15G BIOPSY CORING TOOL ASPIRATIONS, 1.1 MM UP-TBLC, FORCEPS BIOPSY AND BRONCHOALVEOLAR LAVAGE (BAL). THREE INCIDENTS OF PNEUMOTHORAX (5%) OCCURRED. ALL REQUIRED INTERVENTIONS. ONE WAS DISCHARGED ON THE SAME DAY WITHOUT SMALL BORE CHEST TUBE (SBCT) AFTER SUCCESSFUL MANUAL ASPIRATION, ONE DISCHARGED WITH SBCT FOR AMBULATORY MANAGEMENT AND ONE HOSPITALIZED WITH SBCT AFTER FAILING MANUAL ASPIRATION. BOTH CHEST TUBES WERE REMOVED WITHIN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumothorax

  MAUDE report 16746827 ↗
• InjuryJul 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER DURING THE PROCEDURE, THE DEVICES HAD NO DEFECTS AND THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE. THE PATIENT EXPERIENCED PNEUMOTHORAX AND HAD TO USED CHEST TUBE. THE EVENT HAS LEAD TO OR EXTEND PATIENT HOSPITALIZATION.

  Patient problems: Pneumothorax

  MAUDE report 14887649 ↗
• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. TO RESOLVE THE ISSUE, A CHEST TUBE WAS USED AND THE PATIENT WAS HOSPITALIZED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THE PATIENT HAD AN EXTENDED PATIENT HOSPITALIZATION AS WELL.

  Patient problems: Pneumothorax

  MAUDE report 14103168 ↗
• InjuryJan 28, 2020Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Break; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE NEEDLE BROKE AT THE PROXIMAL END WHEN THE TECH PULLED THE NEEDLE BACK INTO THE SHAFT. THE WHITE SEPARATED FROM THE BLUE END OF THE DEVICE. THE TECH DID PULL VERY HARD ON THE DEVICE TO PULL THE NEEDLE BACK INTO THE SHAFT. THE PATIENT HAD PNEUMOTHORAX, BUT THE PHYSICIAN BELIEVED THAT THE EXTREME MOVEMENT OF THE PATIENT'S COUGHING DURING THE CASE CAUSED THE PNEUMOTHORAX, AND WAS NOT CAUSED BY THE NEEDLE BROKEN HANDLE. THE PATIENT HAD TO SPEND THE NIGHT AT THE HOSPITAL.

  Patient problems: Pneumothorax

  MAUDE report 9638876 ↗