—#191288

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

FDA product code: NJK — Valve, Pulmonary
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P180007
Affected lot / code info: Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024

Why it was recalled

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

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Gyrus ACMI Inc. (Olympus) issued Urgent Medical Device Correction Letter dated 12/23/21. Letter states reason for recall, health risk and action to take: Inspect your inventory for the referenced device and identify any devices with the model number and lot number specified above. Please check all areas of the hospital to determine if any of these devices remain in inventory. Please contact Customer Service 1-888-524-7266, option 1, to obtain a Return Material Authorization. Olympus will issue a credit or replacement to your facility for your affected product. 2. Review your facility s use of the patient charge labels. If your facility has used these mislabeled patient charge labels in the patient s chart, or scanned into electronic medical records and/or patient implant cards please request replacement labels by indicating the quantity in the Recall Portal (see Step 3). Olympus will ship replacement labels for you to use in correcting your patient records. In the case of labels sent with patients at discharge for their personal records, include an explanation of the situation as described above. 3. Access the Olympus recall portal to indicate that you have received this notification. Go to https://olympusamerica.com/recall. Enter the recall number "0403 and provide your contact information as indicated in the portal. As you are most likely aware and as provided in the labeling for the product, for any subsequent procedures with that patient, the SVS endobronchial valve size selection is based on patient anatomy using a sizing kit (SVS-VSK-06) and the fit is verified by a trained clinician after placement according to the product s instruction manual. As a result, the mislabeled patient charge label was determined to not adversely affect medical treatment. However, Olympus recognizes that there may be confusion about what product size was previously used and is therefore sending this notice to you. Olympus requests you to report any complaints, including product l

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.

Timeline

Recall initiated: 2021-12-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #191288. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.