Olympus Spiration Valve System mislabeled with incorrect model number
Olympus Corporation is recalling 35 units of the Spiration Valve System (SVS-V9-00) due to a mislabeled patient charge label indicating model SVS-V7-00 instead. The incorrect label could confuse healthcare providers about which valve was implanted.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a labeling documentation error with no reported illnesses or injuries. The hazard is administrative (incorrect model documentation) rather than a physical device defect, fitting the criterion for minor labeling errors.
Plain-English summary
The Spiration Valve System (SVS-V9-00) is a one-way endobronchial valve indicated for adult patients with shortness of breath and hyperinflation. Olympus Corporation of the Americas is recalling 35 units due to an error on the patient charge label.
The patient charge label on the affected units indicates model number SVS-V7-00 (7mm) instead of the correct model SVS-V9-00 (9mm). This labeling error could lead to confusion among healthcare providers about which valve model was implanted in the patient.
The recalled units were distributed nationwide to healthcare facilities in Arizona, California, Massachusetts, New Jersey, Pennsylvania, South Carolina, Texas, and Wisconsin. The affected lot number is WS147887-01 with expiration date 4/30/2024.
If you have received or used any of these devices, contact Olympus Corporation of the Americas immediately to verify the correct model number and ensure accurate documentation of the implanted device.
The recalled product
- Product
- 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
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
Distribution
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