Reported Feb 9, 2022 · Ongoing

Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with…

Olympus Corporation of the Americas

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Olympus Corporation of the Americas · 3500 Corporate Pkwy · Center Valley, PA · 18034-8229

Is this the product you have?

  • Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of
  • breath and hyperinflation Model NumberSVS-V9-00
Lot codes and dates
  • Lot NumberWS147887-01
  • UDI896506002309
  • Expiration Date4/30/2024
Amount recalled
35 units

Where it was sold

Why it was recalled

Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:29 PM UTC

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