Zephyr Endobronchial ValveRecalls & reported problems across all models
Pulmonx Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Zephyr Endobronchial Valve model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,169
- Deaths reported
- 113
- Injuries reported
- 1,051
- Recalls
- 1
We found 4 models of Zephyr Endobronchial Valve by Pulmonx Corporation in the FDA's device registry (GUDID). Together they are named in 1,169 adverse event reports in the FDA's MAUDE database, received between Nov 21, 2018 and Sep 25, 2026 — classified as 113 deaths, 1,051 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (31 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Zephyr Endobronchial Valve recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 31, 2023Open, Classified
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.
Z-0235-2024 · Root cause: Error in labeling · Recall details · FDA record ↗
Most reported Zephyr Endobronchial Valve problems
Device problems
- Adverse Event Without Identified Device or Use Problem1,147
- Insufficient Device Problem Information31
- Detachment of Device or Device Component1
- Device Damaged Prior to Use1
- Firing Problem1
- Migration1
- Premature Activation1
Patient problems
- Pneumothorax1,100
- Pneumonia35
- Respiratory Failure35
- Pleural Effusion27
- Cardiac Arrest21
- Death19
- Insufficient Information15
- Atrial Fibrillation13
Zephyr Endobronchial Valve models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zephyr Endobronchial Valve EBV-TS-4.0Valve, Pulmonary36 deaths387 reports
- Zephyr Endobronchial Valve EBV-TS-4.0-LPValve, Pulmonary22 deaths295 reports
- Zephyr Endobronchial Valve EBV-TS-5.5Valve, Pulmonary31 deaths282 reports
- Zephyr Endobronchial Valve EBV-TS-5.5-LPValve, Pulmonary1 recall24 deaths205 reports
Recent Zephyr Endobronchial Valve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathSep 25, 2026Insufficient Device Problem Information
The patient underwent a BLVR revision procedure. The patient died (b)(6) 2026. Investigation is ongoing.
Patient problems: Insufficient Information
MAUDE report 50904471 ↗DeathSep 25, 2026Insufficient Device Problem Information
The patient underwent a BLVR revision procedure. The patient died (b)(6) 2026. Investigation is ongoing.
Patient problems: Insufficient Information
MAUDE report 50904470 ↗DeathSep 25, 2026Insufficient Device Problem Information
The patient underwent a BLVR revision procedure. The patient died (b)(6) 2026. Investigation is ongoing.
Patient problems: Insufficient Information
MAUDE report 50904469 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50680619 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50680618 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50680617 ↗InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem
Patient problems: Pneumothorax
MAUDE report 50680616 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT AND EXPERIENCED A PNEUMOTHORAX. CHEST TUBE WAS PLACED ON THE SAME DAY. CHEST TUBE WAS REMOVED (B)(6) 2026. RESOLUTION DATE WAS RECORDED AS (B)(6) 2026.
Patient problems: Pneumothorax
MAUDE report 24274124 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT. LATER THAT DAY, THE PATIENT REPORTED SHORTNESS OF BREATH AND RIGHT-SIDE CHEST PAIN. A CHEST X-RAY CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2026. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE CHEST TUBE WAS REMOVED ON (B)(6) 2026, THE RESOLUTION DATE OF THE EVENT.
Patient problems: Pneumothorax
MAUDE report 24274095 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT. LATER THAT DAY, THE PATIENT REPORTED SHORTNESS OF BREATH AND RIGHT-SIDE CHEST PAIN. A CHEST X-RAY CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2026. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE CHEST TUBE WAS REMOVED ON (B)(6) 2026, THE RESOLUTION DATE OF THE EVENT.
Patient problems: Pneumothorax
MAUDE report 24274093 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT. LATER THAT DAY, THE PATIENT REPORTED SHORTNESS OF BREATH AND RIGHT-SIDE CHEST PAIN. A CHEST X-RAY CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2026. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE CHEST TUBE WAS REMOVED ON (B)(6) 2026, THE RESOLUTION DATE OF THE EVENT.
Patient problems: Pneumothorax
MAUDE report 24274080 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT AND EXPERIENCED A PNEUMOTHORAX. CHEST TUBE WAS PLACED ON THE SAME DAY. CHEST TUBE WAS REMOVED (B)(6) 2026. RESOLUTION DATE WAS RECORDED AS 02/03/2026.
Patient problems: Pneumothorax
MAUDE report 24274079 ↗InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT. LATER THAT DAY, THE PATIENT REPORTED SHORTNESS OF BREATH AND RIGHT-SIDE CHEST PAIN. A CHEST X-RAY CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2026. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE CHEST TUBE WAS REMOVED ON (B)(6) 2026, THE RESOLUTION DATE OF THE EVENT.
Patient problems: Pneumothorax
MAUDE report 24274077 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, THE PATIENT RECEIVED VALVE PLACEMENT AND EXPERIENCED A PNEUMOTHORAX. CHEST TUBE WAS PLACED ON (B)(6) 2025. INVESTIGATION IS ONGOING.
Patient problems: Pneumothorax
MAUDE report 23618489 ↗InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, THE PATIENT RECEIVED VALVE PLACEMENT AND EXPERIENCED A PNEUMOTHORAX. CHEST TUBE WAS PLACED ON (B)(6) 2025. INVESTIGATION IS ONGOING.
Patient problems: Pneumothorax
MAUDE report 23618354 ↗
Other Pulmonx Corporation products
All Pulmonx Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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