Z-0551-2022Class II

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

Name: Z-0551-2022 Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients...
Creator: Olympus Corporation of the Americas
Published: 2021-12-23
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-12-23 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model... on 2021-12-23. FDA classified it as Class II and gives the reason as "Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0551-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-12-23
Posted: 2022-02-01
Recalling firm: OLYMPUS Corporation of the Americas
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
Product code: NJK Valve, Pulmonary
Reason for recall: Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
Root cause tag: labeling and UDI
FDA root 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.
Product codes and lots: Lot Number: WS147887-01 UDI: 896506002309 Expiration Date: 4/30/2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0551-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0551-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-02-09	2022-02-01

Product code NJK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)