Spiration Valve System HUS-V7Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00896506002101), received between Dec 29, 2022 and Jan 19, 2023 — classified as 2 deaths, 1 injury.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• DeathJan 19, 2023Adverse Event Without Identified Device or Use Problem

  FOUR SPIRATION VALVES WERE PLACED IN THE UPPER RIGHT LOBE OF THE LUNG ON (B)(6) 2022. THE PATIENT DEVELOPED PNEUMONIA/ILD FLARE ON POST-OPERATIVE DAY 1. THERE WAS NO PNEUMONIA IN THE SEGMENT TREATED WITH THE VALVES. THE PATIENT WAS TREATED WITH ANTIBIOTICS, STEROIDS, AND O2 SUPPORT. THE PATIENT WAS SUBSEQUENTLY PLACED IN HOSPICE CARE AND DIED ON (B)(6) 2023.

  Patient problems: Pneumonia

  MAUDE report 16206766 ↗
• DeathDec 29, 2022Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH ACUTE DYSPNEA DUE TO SPONTANEOUS RIGHT TENSION PNEUMOTHORAX REQUIRING URGENT CHEST TUBE PLACEMENT. TREATMENT WAS COMPLICATED BY PERSISTENT AIR LEAK (PAL) AND PNEUMONIA. PATIENT UNDERWENT RIGHT VIDEO-ASSISTED THORASCOPIC SURGERY (VATS). WHAT APPEARED TO BE A RIGHT MIDDLE LOBE ALVEOLAR-PLEURAL FISTULA WAS IDENTIFIED. ATTEMPTS TO TREAT WITH SEALANTS WERE UNSUCCESSFUL. ENDOBRONCHIAL VALVES (MANUFACTURER BRAND NOT KNOWN) WERE PLACED IN TREATMENT OF AIR LEAK. PLACEMENT OF AN INTRABRONCHIAL VALVE (IBV) IN THE RML BRONCHUS WAS COMPLETED. THE AIR LEAK SIGNIFICANTLY DECREASED, THEN RESOLVED WITHIN TWO DAYS. ONE MONTH LATER, SEPSIS AND A PLEURO-CUTANEOUS FISTULA WITH AIR LEAK DEVELOPED AT THE SITE OF THE PREVIOUS CHEST TUBE INSERTION. A CHEST TUBE WAS PLACED FOLLOWED BY AN ELOESSER WINDOW PROCEDURE TO DRAIN THE INFECTED PLEURAL SPACE. THE PATIENT REMAINED HOSPITALIZED FOR ABOUT TWO MONTHS AND EXPIRED FROM SEPTIC AND CARDIAC COMPLICATIONS.

  Patient problems: Fistula; Sepsis

  MAUDE report 16069834 ↗
• InjuryDec 29, 2022Migration; Migration

  THREE ENDOBRONCHIAL VALVES (EBV) WERE PLACED IN VARIOUS LEFT SIDED SEGMENTS TO TREAT A BRONCHOPLEURAL FISTULA (BPF) AND ALVEOLAR-PLEURAL FISTULA WITH PERSISTENT AIR LEAK (PAL) FOLLOWING LEFT UPPER LOBECTOMY. MORE THAN 2 YEARS POST SPIRATION VALVE PLACEMENT, PATIENT PRESENTED WITH DYSPNEA ON EXERTION, OCCASIONAL SMALL-VOLUME HEMOPTYSIS AS WELL AS SIGNIFICANT WEIGHT LOSS IN THE PREVIOUS 6 MONTHS. A CT SCAN SHOWED A PNEUMOTHORAX; ONE EBV REMAINED WELL POSITIONED IN A SEGMENTAL BRONCHUS, WHEREAS THE OTHER 2 APPEARED TO HAVE MIGRATED INTO THE PLEURAL SPACE. THE TWO VALVES THAT WERE FOUND TO HAVE PASSED INTO PLEURAL SPACE WERE REMOVED. THIS WAS AN OFF-LABEL USE. UNDER THIS INDICATION FOR USE (TREATMENT OF AIR LEAK) THE VALVES ARE TO BE REMOVED AFTER SIX WEEKS.

  Patient problems: Pneumothorax

  MAUDE report 16069805 ↗