Spiration Valve System SVS-C26N-06Recalls & reported problems
Gyrus Acmi, Llc · Deployment Catheter and Loader, 2.6 · Class 3
All models of Spiration Valve System (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00896506002316), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 malfunction.
1 other recall cover devices cleared under the same FDA submission (P180007); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 5, 2024
DEPLOYMENT CATHETER FOR PULMONARY VALVE PLACEMENT FAILED TO ATTACH TO TWO DIFFERENT SPIRATION PULMONARY VALVES, RENDERING THEM UNABLE TO BE USED FOR MEDICAL PURPOSES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609169 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P180007. One submission often covers many models, so check the product and lot details in each record.
- Z-0551-2022 · Dec 23, 2021 · Open, ClassifiedSpiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00
Other Valve, Pulmonary devices
- Zephyr Endobronchial Valve EBV-TS-4.0Pulmonx Corporation · Valve, Pulmonary36 deaths387 reports
- Zephyr Endobronchial Valve EBV-TS-4.0-LPPulmonx Corporation · Valve, Pulmonary22 deaths295 reports
- Zephyr Endobronchial Valve EBV-TS-5.5Pulmonx Corporation · Valve, Pulmonary31 deaths282 reports
- Zephyr Endobronchial Valve EBV-TS-5.5-LPPulmonx Corporation · Valve, Pulmonary1 recall24 deaths205 reports
- Spiration Valve System SVS-V9-00Gyrus Acmi, Llc · Valve, Pulmonary1 recall5 deaths100 reports
- Spiration Valve System SVS-V7-00Gyrus Acmi, Llc · Valve, Pulmonary3 deaths84 reports
- Zephyr Delivery Catheter EDC-TS-4.0-JPulmonx Corporation · Valve, Pulmonary32 reports
- Spiration Valve System SVS-V6-00Gyrus Acmi, Llc · Valve, Pulmonary1 death31 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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