CrossCountry SDATSW01 (UDI 10884521539723)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521539723), received between Dec 19, 2019 and Jul 5, 2024 — classified as 6 injuries.

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.

• InjuryJul 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB) AND ABLATION PROCEDURE, THE PATIENT HAD EXPERIENCE PNEUMOTHORAX ON THE LEFT LUNG WHICH IS CONFIRMED TO BE NOT DEVICE RELATED AND HAS A PROBABLE RELATIONSHIP TO THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 19685130 ↗
• InjuryFeb 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE ARC POINT NEEDLE HAD PUNCTURED THE FISSURE LEADING TO PNEUMOTHORAX ON A NON-MEDTRONIC PRODUCT. RIGHT CHEST DRAIN INSERTION AND CHEMICAL PLEURODESIS WAS PERFORMED AND THE PROCEDURE CONTINUED. VENTOLIN BY ORAL INHALATION AND HYDROCORTISONE BY INTRAVENOUS INJECTION WAS GIVEN. THE HOSPITALIZATION OF THE PATIENT WAS PROLONGED. THE ADVERSE EVENT HAS PROBABLE RELATION TO THE DEVICES AND STUDY PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 16414167 ↗
• InjuryMay 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE, THIS STUDY AIMED TO ASSESS THE OUTCOME OF TRANSBRONCHIAL MICROWAVE ABLATION OF LUNG NODULES WITH ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY GUIDANCE. TOTAL OF 30 LUNG NODULES FROM 25 PATIENTS WERE TREATED. MILD IMMEDIATE OR DELAYED PLEURITIC CHEST PAIN WAS PRESENT IN 4 CASES (13.3%) AND RESPONDED TO COMMON ORAL ANALGESICS AND DID NOT PROLONG HOSPITAL STAY. ALL 4 OF THE LESIONS WERE CLOSE TO PLEURA, AND THE MECHANISM OF PAIN COULD BE DUE TO PLEURAL IRRITATION AFTER ABLATION OF PERIPHERALLY LOCATED LUNG NODULES. NO REFERRED PAIN TO SHOULDER DUE TO PHRENIC NERVE INJURY, OR REFERRED PAIN TO ARM DUE TO BRACHIAL PLEXUS INJURY OCCURRED. PNEUMOTHORAX OCCURRED IN 2 CASES (6.67%) AND BOTH REQUIRED CHEST DRAIN INSERTION. POST ABLATION REACTION INCLUDING FEVER OCCURRED IN 2 CASES (6.67%); WHILE MILD HEMOPTYSIS WAS NOTED IN 1 CASE (3.33%).

  Patient problems: Pain; Pneumothorax

  MAUDE report 11900943 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT COMPLAINED OF BLOOD STAINED SPUTUM WHILE ADMITTED FOR POST ABLATION SYNDROME. THE PATIENT WAS TREATED WITH ORAL TRANSAMIN. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2020 TO (B)(6) 2020.

  Patient problems: Hemoptysis

  MAUDE report 10413253 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, THE PATIENT HAD TWO WEEKS OF BREATHLESSNESS. IT BEGAN ON (B)(6) AND CONTINUED UNTIL THE 15TH WHEN THE PATIENT WENT TO THE HOSPITAL. THE COMPUTED TOMOGRAPHY (CT) SHOWED 3CM PLEURAL EFFUSION, AND SATURATION OF 96% ON ROOM AIR. THE PATIENT WAS ADMITTED FOR ULTRASOUND GUIDED AIRWAY AND TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION. THE ULTRASOUND SHOWED VERY SMALL FLUID, THE SMALL PLEURAL EFFUSION WAS DETERMINED TO BE PROBABLY RELATED TO THE ABLATION PROCEDURE, BECAUSE THE ABLATION ZONE REACHED THE LUNG SURFACE, MIL/OR NIL WAS ASPIRATED. THE PATIENT WAS GIVEN ANTIBIOTICS AND STEROIDS. THE COPD EXACERBATION WAS SEEN TO BE POSSIBLY RELATED TO THE ABLATION PROCEDURE, BUT THE PATIENT NORMALLY GETS THAT WITH HOT WEATHER AND IT HAPPENED 2 WEEKS AFTER DISCHARGE, IT WAS TREATED WITH ANTIBIOTICS AND STEROIDS. THE PATIENT CONDITION IMPROVED AND WAS THEN DISCHARGED. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2020 - (B)(6) 2020.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Dyspnea; Pleural Effusion

  MAUDE report 10399459 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVELY, PATIENT HAD SMALL AMOUNT OF HAEMOPTYSIS. CT THORAX WAS PERFORMED AND THE SYMPTOM WAS RESOLVED. THE PATIENT HOSPITALIZATION WAS EXTENDED.

  Patient problems: Blood Loss

  MAUDE report 9500052 ↗