Zephyr Endobronchial Valve recallZ-0235-2024 · Pulmonx, Corp. · initiated Aug 31, 2023
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Pulmonx, Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.
FDA root cause category: Error in labeling
What the company is doing
On 8/31/23, correction notices were emailed to customers who were asked to do the following: 1) The affected lot can be used without risk to the patient until 08 December 2024. In addition, this lot was manufactured on 2021-12-08. 2) Check your inventory and keep this letter with any remaining product of the affected lot to support the corrected manufacture and expiration date. 3) Send a response email acknowledging receipt that includes the number of affected devices remaining at your site. Customers with questions can call 650-743-6848.
Recall details
- Recall number
- Z-0235-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 31, 2023
- Posted by the FDA
- Nov 6, 2023
- Recalling firm
- Pulmonx, Corp.
- Quantity
- 144
- Product code
- NJK
- FDA submissions
- P180002
- Distribution
- US: TN, WV, AR, PA, VA, NC, IL, IA, MA, NY, NJ, WA, CO, OR, MI, FL, OH, TX, OK, AZ, NV, WI
Product description
Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Code information (models, lots, serial numbers)
UDI: (01)00811907030423(10)506590V70(17)241208, Lot: 506590-V7.0
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Zephyr Endobronchial Valve EBV-TS-5.5-LPPulmonx Corporation · Valve, Pulmonary1 recall24 deaths205 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under P180002 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Zephyr Endobronchial Valve EBV-TS-4.0Pulmonx Corporation · Valve, Pulmonary36 deaths387 reports
- Zephyr Endobronchial Valve EBV-TS-4.0-LPPulmonx Corporation · Valve, Pulmonary22 deaths295 reports
- Zephyr Endobronchial Valve EBV-TS-5.5Pulmonx Corporation · Valve, Pulmonary31 deaths282 reports
- Zephyr Delivery Catheter EDC-TS-4.0-JPulmonx Corporation · Valve, Pulmonary32 reports
- Zephyr Delivery Catheter EDC-TS-5.5-DMPulmonx Corporation · Valve, Pulmonary23 reports
- Zephyr Delivery Catheter EDC-TS-4.0Pulmonx Corporation · Valve, Pulmonary15 reports
- Zephyr Delivery Catheter EDC-TS-5.5Pulmonx Corporation · Valve, Pulmonary2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page