Home › Gyrus Acmi, Llc › Spiration Valve System
Spiration Valve System
Gyrus Acmi, Llc · Model SVS-V6-00 · UDI-DI 00896506002293
NJK
Prescription
0
510(k) clearances
2,013
Adverse events (179 deaths)
3
Recalls
7
Facilities
Description
Valve in Cartridge, 6mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-08-31 | Pulmonx, Corp. | 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. |
| 2021-12-23 | Olympus Corporation of the Americas | Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm) |
| 2003-09-10 | Cryolife Inc | 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 i |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.