Spiration Valve System HUS-V9Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00896506002200), received between Apr 26, 2022 and Jan 19, 2023 — classified as 4 deaths, 2 injuries.

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 6 most recent of 6 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 16206796 ↗
• 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 16206582 ↗
• 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 16206507 ↗
• DeathOct 18, 2022Gas/Air Leak

  OLYMPUS RECEIVED A REPORT FROM USER FACILITY STATING A PATIENT ADMITTED WITH COVID WAS EXPERIENCING AIR LEAKS FROM BOTH OF HIS CHEST TUBES SUGGESTING BRONCHOPLEURAL FISTULA. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR AN ENDOBRONCHIAL VALVE PLACEMENT. ON (B)(6) 2021 THREE SPIRATION VALVES WERE PLACED FOR THE TREATMENT OF THE BRONCHOPLEURAL FISTULA. TREATMENT WAS UNSUCCESSFUL AS PATIENT BECAME BRADYCARDIC AND HYPOXIC. VALVES WERE REMOVED AND THE BRADYCARDIA AND HYPOXIA RESOLVED. ON (B)(6) 2021 THE PATIENT DEVELOPED HYPOTENSION AND BRADYCARDIA AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS STARTED AND PATIENT ACHIEVED RETURN OF SPONTANEOUS CIRCULATION, THOUGH CONTINUED TO ARREST SEVERAL MORE TIMES DESPITE FULL MEDICAL RESUSCITATION. THE PATIENT PASSED AWAY SEVERAL MINUTES LATER AFTER EXPERIENCING ANOTHER CARDIAC ARREST.

  Patient problems: Low Oxygen Saturation

  MAUDE report 15621353 ↗
• InjuryApr 26, 2022Migration; Migration

  VALVE MIGRATION DISCOVERED FROM A CLINICAL LITERATURE SEARCH TAKEN FROM: HTTPS://WWW.ATSJOURNALS.ORG/DOI/ABS/10.1164/AJRCCM-CONFERENCE.2021.203.1_MEETINGABSTRACTS.A2193 RIGGLE ET AL, BILATERAL ENDOBRONCHIAL VALVES: AN OPTION FOR SEVERE BILATERAL PERSISTENT AIR LEAK; AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE 2021;203:A2193. THE ARTICLE DISCUSSES THE OFF LABEL USE OF ASPIRATION ENDOBRONCHIAL VALVES TO TREAT PERSISTENT BRONCHOPLEURAL FISTULAS (BPF) IN AN UNSTABLE PATIENT. LARGE BILATERAL PALS WITH RESIDUAL PNEUMOTHORAXES DID NOT RESOLVE AFTER PLACEMENT OF BILATERAL THORACOSTOMY TUBES. VENOVENOUS ECMO WAS INITIATED DUE TO HYPERCAPNIA AND HYPOXIA ON MAXIMAL VENTILATOR SETTINGS. TO PROMOTE PLEURODESIS WITH CONTINUED LARGE BILATERAL PAL, ASPIRATION IBVS WERE DEPLOYED TO RB 1, RB 2, RB 3, LB 1-3, AND LB 4-5. BLOOD PATCH PLEURODESIS WAS ALSO PERFORMED BILATERALLY. IBVS AT RB 3 AND LB 4-5 WERE SUBSEQUENTLY FOUND TO HAVE MIGRATED AND WERE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING MIGRATION OF THE TWO VALVES. PATIENT WAS EVENTUALLY TRANSFERRED ON ECMO FOR LUNG TRANSPLANT EVALUATION DUE TO SEVERE IRREVERSIBLE PULMONARY PARENCHYMAL DISEASE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hypoxia; Pneumothorax

  MAUDE report 14215138 ↗
• InjuryApr 26, 2022Output Problem

  LITERATURE COMPLAINT RELATED SPIRATION VALVE SYSTEM (UNKNOWN MODEL) PRINTED INHTTPS://WWW.ATSJOURNALS.ORG/DOI/ABS/10.1164/AJRCCM-CONFERENCE.2020.201.1_ MEETINGABSTRACTS.A3156 MARINAK L, AHMAD K, PETERSON J, KING C, KATUGAHA S, MAHAJAN A, BROWN A. ENDOBRONCHIAL VALVES FOR PERSISTENT BRONCHOPLEURAL FISTULA AFTER PNEUMOTHORAX IN CYSTIC FIBROSIS: A DOUBLE EDGED SWORD. CONFERENCE ABSTRACT. AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE A PATIENT WITH ADVANCED CYSTIC FIBROSIS UNDERGOING LUNG TRANSPLANT EVALUATION EXPERIENCED PERSISTENT PNEUMOTHORAX AND BRONCHOPLEURAL FISTULA (BPF) AFTER PLACEMENT OF CHEST TUBE TO TREAT PNEUMOTHORAX. FOUR SPIRATION VALVES WERE PLACED IN THE RIGHT UPPER LOBE TO TREAT THE PNEUMOTHORAX AND BPF. THIS IS AN OFF-LABEL USE. PATIENT EXPERIENCED PERSISTENT AIRWAY INFECTION AND WAS TREATED WITH ANTIBIOTICS. WHEN ANTIBIOTICS WERE DISCONTINUED, PATIENT THEN DEVELOPED A FEVER AND LEUKOCYTOSIS. PATIENT WAS THEN TREATED WITH IV ANTIBIOTICS UNTIL LUNG TRANSPLANT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH ENDOBRONCHIAL VALVES IN PLACE AND ONGOING IV ANTIBIOTIC THERAPY. THREE MONTHS LATER, THE PATIENT UNDERWENT A BILATERAL LUNG TRANSPLANT.

  Patient problems: Bacterial Infection; Pneumonia

  MAUDE report 14214769 ↗