Spiration Valve System HUS-V5Recalls & reported problems
Gyrus Acmi, Llc · Valve in Cartridge , 5mm · Class f · Implant
All models of Spiration Valve System (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00896506002088), received between May 4, 2023 and May 4, 2023 — classified as 1 death.
The most frequently reported specific device problem is “Off-Label Use” (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
Device problems
- Off-Label Use1
Patient problems
- Cardiac Arrest1
- Hemoptysis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMay 4, 2023Off-Label Use; Off-Label Use
A LITERATURE CASE STUDY PRESENTED ON THE BRONCHOSCOPIC MANAGEMENT OF HEMOPTYSIS CAUSED BY AIRWAY EROSION FROM VASCULAR COILS. PATIENT SUFFERED FROM HUGHES-STOVIN SYNDROME, ANTIPHOSPHOLIPID ANTIBODY SYNDROME, AND RECURRENT PULMONARY EMBOLI RECEIVING CHRONIC IMMUNE SUPPRESSION AND CHRONIC ANTICOAGULATION AND PRESENTED WITH MASSIVE HEMOPTYSIS. ONE YEAR PRIOR, THE PATIENT HAD DEVELOPED MASSIVE HEMOPTYSIS DUE TO A LEFT LOWER LOBE PULMONARY ARTERY ANEURYSMAL RUPTURE TREATED WITH SURGICAL RESECTION. THREE MONTHS PRIOR, A PATIENT DEVELOPED MASSIVE HEMOPTYSIS SECONDARY TO THE RIGHT LOWER LOBE (RLL) ANEURYSMAL RUPTURE, WHICH WAS TREATED WITH VASCULAR COIL EMBOLIZATION. CROSS-SECTIONAL IMAGING AT THE SITE SHOWED THE MOST LIKELY SOURCE OF BLEEDING TO BE AN EROSION OF A VASCULAR COIL THROUGH A VESSEL WALL INTO THE RLL ANTERIOR SEGMENT BRONCHUS. BILATERAL AIRWAY INSPECTION SHOWED NO FRESH BLEEDING AND NO GROSSLY APPARENT VASCULAR ABNORMALITIES BUT A SMALL AMOUNT OF OLD BLOOD IN THE RLL BRONCHIAL TREE AND VASCULAR COILS VISIBLE IN THE R B8 SEGMENTAL BRONCHUS. IT WAS DECIDED TO ATTEMPT TO MAXIMIZE LOCAL CONTAINMENT IN THE EVENT OF MASSIVE FUTURE RE-BLEEDING FROM WITH AREA. THE PATIENT WAS REF
Patient problems: Cardiac Arrest; Hemoptysis
MAUDE report 16870960 ↗
Other One-Way Air-Leak Valve devices
- Spiration Valve System HUS-V9Gyrus Acmi, Llc · One-Way Air-Leak Valve4 deaths6 reports
- Spiration Valve System HUS-V7Gyrus Acmi, Llc · One-Way Air-Leak Valve2 deaths3 reports
- Spiration Valve System HUS-C26NGyrus Acmi, Llc · One-Way Air-Leak Valve2 reports
- Spiration Valve System HUS-V6Gyrus Acmi, Llc · One-Way Air-Leak Valve2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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