Valve, Pulmonary
FDA adverse event reports and recall history for valve, pulmonary (product code NJK), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 2,016
- Deaths
- 179
- Injuries
- 1,713
- Malfunctions
- 124
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2023-11-06Open, ClassifiedError in labeling
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
- 2003-10-15TerminatedOther
CryoValve, Pulmonary Valve & Conduit
Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
- Open, ClassifiedLabeling Change Control
Spiration 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
Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
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