CrossCountry SDATSW01 (UDI 10884521809536)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521809536), received between Jun 13, 2024 and Aug 28, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE LITERATURE SOURCE OF STUDY PERFORMED BETWEEN MARCH 2019 TO FEBRUARY 2024, A RETROSPECTIVE STUDY ANALYZED THE HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION WITH CONCOMITANT VIDEO-ASSISTED THORACOSCOPIC LUNG RESECTION. A TOTAL OF 92 PATIENTS WERE INCLUDED IN THE STUDY. THERE WERE 103 PROCEDURES PERFORMED AND 162 LUNG NODULES TREATED 142 LUNG NODULES WERE ABLATED AND 20 LUNG NODULES WERE RESECTED. 6 PATIENTS HAD COMPLICATIONS INCLUDING (1) PERSISTED FEVER, (2) AIRWAY BLEEDING, (2) PNEUMOTHORAX AND (1) BRONCHOPLEURAL FISTULA. ORAL ANTIBIOTICS WERE GIVEN, CHEST TUBE DRAINAGE WAS DONE AND ENDOBRONCHIAL VALVE PLACEMENT ON. RE-ADMISSION WAS REQUIRED.

  Patient problems: Fever; Fistula; Pneumothorax

  MAUDE report 22919988 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE THERMOABLATION PROCEDURE, THE PATIENT HAD PNEUMOTHORAX ON THE LEFT SIDE. CHEST DRAINAGE WAS THEN PERFORMED. NINE DAYS AFTER THE PROCEDURE, THE PATIENT HAD COMPRESSIVE RIGHT PNEUMOTHORAX POST ENDOSCOPIC THERMOABLATION OF BILATERAL PULMONARY METASTASES FROM AN ADENOCARCINOMA OF THE UPPER RECTUM. CHEST TUBE WAS USED UNDER LOCAL ANESTHESIA WITH IMMEDIATE BUBBLING. THE PATIENT HOSPITALIZATION WAS PROLONGED AS A RESULT. THE PATIENT SITE RELATED ASSESSMENT INDICATES THAT THE ADVERSE EVENT WAS NOT DEVICE RELATED BUT HAS PROBABLE RELATION TO THE STUDY PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 19537398 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, ON POST OPERATIVE ABLATION PROCEDURE, THE PATIENT HAD LEFT PLURAL EFFUSION. LEFT PLEURAL SELDINGER DRAIN INSERTED. X-RAY WAS DONE AND THE PATIENT HAD PROLONGED HOSPITALIZATION. THE SITE RELATED ASSESSMENT INDICATES THE ADVERSE EVENT WAS NOT DEVICE RELATED BUT HAS PROBABLE RELATION TO THE STUDY PROCEDURE.

  Patient problems: Pleural Effusion

  MAUDE report 19534438 ↗