ArcpointRecalls & reported problems across all models

We found 4 models of Arcpoint by Covidien LP in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Aug 14, 2018 and Sep 16, 2026 — classified as 16 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Arcpoint problems

Arcpoint models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Arcpoint ILS-1800-PN

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  9 reports
• Arcpoint ILS-2100-PN

  BRONCHOSCOPE (FLEXIBLE OR RIGID)
  6 reports
• Arcpoint ILS-2100-PN

  Bronchoscope (flexible or rigid)
  4 reports
• Arcpoint ILS-1800-PN

  Bronchoscope (flexible or rigid)
  2 reports

Recent Arcpoint adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE PATIENT HAD A PNEUMOTHORAX. THE PATIENT HAD TO GET A CHEST TUBE. THE EVENT HAD LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THE PATIENT HAD TEMPORARY INJURY AS A RESULT.

  Patient problems: Pneumothorax

  MAUDE report 19299907 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE BIOPSY ON THE RIGHT LUNG (GROUND GLASS OPACITIES), NEEDLE AND FORCEPS WERE USED AND NO BLEEDING WAS FOUND. WHEN THE PROCEDURE ENDED AND THE SURGEON WAS DOING MINI BRONCHOALVEOLAR LAVAGE SAMPLING FOR THE SECOND TIME, BLEEDING WAS FOUND ON THE SECOND TIME. 600 MILLILITERS OF BLOOD LOSS WAS REPORTED. THE PATIENT IS ALIVE WITH TWO DAYS STAY IN HOSPITAL. ONE DAY FOR OBSERVATION AND ANOTHER DAY FOR CHEST X-RAY BEFORE DISCHARGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unintended Radiation Exposure

  MAUDE report 15055066 ↗
• InjuryJul 15, 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 PNEUMOTHORAX. TO RESOLVE THE ISSUE, THE SURGEON USED A CHEST TUBE. THE PATIENT HAD TO EXTEND HOSPITALIZATION FOR ONE DAY.

  Patient problems: Pneumothorax

  MAUDE report 15027226 ↗
• 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 ↗
• InjuryMay 12, 2022Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, MONARCH ROBOTIC BRONCHOSCOPE WAS INTRODUCED INTO THE AIRWAYS TO IDENTIFY AND BIOPSY THE LOWER LEFT LUNG (LUL) NODULE WITH THE AID OF THE SYSTEM AND RADIAL PROBE ULTRASOUND. DURING NAVIGATION, THE TIP OF THE NEEDLE SEVERED/ BROKE OFF AND REMAINED IN THE PATIENT'S AIRWAYS. USING NAVIGATION, THE NEEDLE TIP WAS LOCALIZED AND THEN RETRIEVED USING FORCEPS FORCEPS WITHOUT COMPLICATION. POST PROCEDURE, CHEST X-RAY SHOWED NO FOREIGN BODY RETAINED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14376274 ↗
• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN DECEMBER 2019 AND FEBRUARY 2020, A RETROSPECTIVE STUDY ANALYZED OUTCOMES OF PATIENTS WHO UNDERWENT ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY UTILIZING SUPERDIMENSION 7.2 FOR THE EVALUATION OF PERIPHERAL PULMONARY NODULES BETWEEN DECEMBER 2019 AND FEBRUARY 2020. EACH PATIENT HAD 7 FINE NEEDLE ASPIRATIONS WITH THE ARCPOINT 18-GAUGE NEEDLE AND 7 FORCEPS SAMPLES COLLECTED WITH THE SUPERDIMENSION BIOPSY FORCEPS. THERE WERE 72 PATIENTS IN THE STUDY, 56 RECEIVED MODERATE SEDATION AND 16 RECEIVED GENERAL ANESTHESIA. FOR SAMPLES DEEMED TO HAVE A NONSPECIFIC DIAGNOSIS, OR PATHOLOGIC FINDING OF ACUTE INFLAMMATION WAS IDENTIFIED AND REPEAT CT SCAN OF THE CHEST DEMONSTRATED A RESOLVED ABNORMALITY, OR HAD FLUOROSCOPY NAVIGATION FAILURE, THESE BIOPSIES WERE CALCULATED AS NONDIAGNOSTIC. COMPLICATIONS IN THE MODERATE SEDATION GROUP INCLUDED 2 PNEUMOTHORAX, WHICH DID NOT REQUIRE CHEST TUBE INSERTION. NO COMPLICATIONS OCCURRED IN THE GENERAL ANESTHESIA GROUP. THERE WAS ONE FLUOROSCOPY NAVIGATION FAILURE IN THE MODERATE SEDATION GROUP (SAMPLES TAKEN BUT NO DIAGNOSIS OBTAINED). THIS COULD PARTIALLY BE BECAUSE OF THE INABILITY TO PERFORM A BR

  Patient problems: Pneumothorax

  MAUDE report 14250554 ↗

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