superDimension AAS00161-20 (UDI 10884521806153)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10884521806153), received between Apr 28, 2022 and Aug 29, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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 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.

• InjuryAug 29, 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. HYBRID TREATMENT OF MULTIFOCAL LUNG MALIGNANCY BY CONCOMITANT TRANSBRONCHIAL MICROWAVE ABLATION WITH SAME-SESSION LUNG RESECTION AND POST-LUNG RESECTION ABLATION. DR. CALVIN NG, 2025, INTERDISCIPLINARY CARDIOVASCULAR AND THORACIC SURGERY.

  Patient problems: Fever; Fistula; Pneumothorax

  MAUDE report 22926491 ↗
• InjuryNov 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST OPERATIVE AN ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY (ENB), THE PATIENT WAS READMITTED TO THE HOSPIT AL DUE TO A SMALL APICAL PNEUMOTHORAX. THE PHYSICIAN WAS ABLE TO COMPLETE THE SUPERDIMENSION PORTION OF THE CASE. THE PATIENT WAS DISCHARGED 2 DAYS LATER WITH THE PNEUMOTHORAX RESOLVED.

  Patient problems: Pneumothorax

  MAUDE report 20662848 ↗
• MalfunctionJun 17, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SCREEN SHOWED A NAVIGATION CATHETER OUT OF SENSING VOLUME ERROR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554299 ↗
• MalfunctionJun 17, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE SCREEN SHOWED A NAVIGATION CATHETER OUT OF SENSING VOLUME ERROR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19549439 ↗
• MalfunctionMay 13, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SCREEN SHOWED A NAVIGATION CATHETER OUT OF SENSING VOLUME. THE ISSUE ONLY LASTED A FEW MOMENTS AND THEN THE SYSTEM WORKED. THE PHYSICIAN WAS ABLE TO COMPLETE THE ELECTROMAGNETIC NAVIGATIONAL BRONCHOSCOPY (ENB) PORTION OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19301397 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE PHYSICIAN WAS ABLE TO COMPLETE THE CASE BUT THE PATIENT EXPERIENCED A SIGNIFICANT BLEEDING, A MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO CONTROL THE BLEEDING. THE PATIENT WAS MOVED TO ICU AND HOSPITALIZED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14234353 ↗