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Spiration Valve System recallZ-0551-2022 · Olympus Corporation of the Americas · initiated Dec 23, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling Change Control

What the company is doing

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

Recall details

Recall number
Z-0551-2022
Status
Open, Classified
Initiated by the company
Dec 23, 2021
Recalling firm
Olympus Corporation of the Americas
Quantity
35 units
Product code
NJK
FDA submissions
P180007
Distribution
US Nationwide distribution in the states of AZ, CA, MA, NJ, PA, SC, TX, WI.

Product description

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 (models, lots, serial numbers)

Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

4 devices cleared under P180007 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page