Spiration Valve System HUS-V6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00896506002095), received between Oct 2, 2018 and Feb 18, 2021 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2021Gas/Air Leak; Migration

  PATIENT EXPERIENCING AIR LEAK HAD THREE SPIRATION VALVES PLACED IN LEFT UPPER LOBE: SIZE 7 IN APICAL; SIZE 7 IN ANTERIOR; SIZE 6 IN APICAL POSTERIOR. AFTER DISCHARGE FROM HOSPITAL, PATIENT DEVELOPED COVID-19 AND POST-OP APPOINTMENT WAS DELAYED. PATIENT WAS SUBSEQUENTLY SCHEDULED FOR VALVE REMOVAL. HEALTHCARE PROVIDER WAS ABLE TO EASILY VISUALIZE TWO OF THE VALVES IN THE LEFT UPPER LOBE, AND SUCCESSFULLY REMOVE THE SIZE 7 IN THE APICAL AND SIZE 7 IN THE ANTERIOR SEGMENTS, BUT HAD DIFFICULTY VISUALIZING THE SIZE 6 IN THE APICAL POSTERIOR SEGMENT. USING A PEDIATRIC BRONCHOSCOPE THE HEALTHCARE PROVIDER COULD SEE THAT THE VALVE HAD MIGRATED DISTALLY AND ATTEMPTED NUMEROUS TIMES TO GRASP THE VALVE AND RETRIEVE IT, BUT WAS UNSUCCESSFUL. AT THIS TIME, IT WAS DEEMED BEST TO HOLD THE PROCEDURE AND HAVE THE PATIENT GET REPEAT IMAGING TO EVALUATE THE VALVE LOCATION. FOLLOWING REPEAT CT CHEST SCAN, HEALTHCARE PROVIDER DECIDED NOT TO REMOVE THE VALVE AS A POSSIBLE THORACOTOMY MAY BE REQUIRED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 11345902 ↗
• InjuryOct 2, 2018Adverse Event Without Identified Device or Use Problem

  PATIENT ADMITTED TO (B)(6) ON (B)(6) 2018 FOR PNEUMONIA. IN DISCUSSION WITH DR. (B)(6), PNEUMONIA COVERS ENTIRE RIGHT SIDE OF THE LUNG, THE SAME SIDE WHERE THE VALVES WERE PLACED. PATIENT STARTED ON IV ANTIBIOTICS. PATIENT IS STILL ADMITTED AND IS CONTINUING ON ANTIBIOTICS.

  Patient problems: Pneumonia

  MAUDE report 7928768 ↗