Class 2 Device Recall Spiration Valve System

• Date Initiated by Firm: December 23, 2021
• Create Date: February 01, 2022
• Recall Status: Open, Classified
• Recall Number: Z-0551-2022
• Recall Event ID: 89333
• PMA Number: P180007
• Product Classification: Valve, pulmonary - Product Code NJK
• 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
• Code Information: Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024
• Recalling Firm/ Manufacturer: Olympus Corporation of the Americas; 3500 Corporate Pkwy; Center Valley PA 18034-8229
• For Additional Information Contact: SAME; 484-896-5000
• Manufacturer Reason for Recall: Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
• FDA Determined Cause: Labeling Change Control
• Action: 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
• Quantity in Commerce: 35 units
• Distribution: US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = NJK and Original Applicant = Gyrus ACMI, Inc.