Zephyr Endobronchial Valve EBV-TS-4.0-LPRecalls & reported problems
Pulmonx Corporation · The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary. · Class 3 · Implant
All models of Zephyr Endobronchial Valve (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Pulmonx Zephyr endobronchial valve is a small implant placed in the airways during a bronchoscopy to reduce lung volume. Most of the 292 reports describe a collapsed lung (pneumothorax) after valve placement, and some patients needed a chest tube. The reports include 21 deaths and 270 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 295
- Deaths reported
- 22
- Injuries reported
- 272
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 295 adverse event reports that list this exact device (DI 00811907030225), received between Dec 11, 2018 and Sep 25, 2026 — classified as 22 deaths, 272 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 reports).
1 other recall cover devices cleared under the same FDA submission (P180002); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem285
- Insufficient Device Problem Information12
- Device Damaged Prior to Use1
- Premature Activation1
Patient problems
- Pneumothorax277
- Pneumonia7
- Insufficient Information6
- Atrial Fibrillation4
- Death4
- Cardiac Arrest3
- Pleural Effusion3
- Pulmonary Edema3
Recent adverse event reports
The 25 most recent of 295 reports, 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 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 50680617 ↗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 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 ↗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 ↗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 23618307 ↗DeathNov 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT RECEIVED EBV VALVES ON (B)(6) 2025 AND EXPIRED IN THE EVENING. INVESTIGATION IS ONGOING.
Patient problems: Insufficient Information
MAUDE report 23556578 ↗DeathNov 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT RECEIVED EBV VALVES ON (B)(6) 2025 AND EXPIRED IN THE EVENING. INVESTIGATION IS ONGOING.
Patient problems: Insufficient Information
MAUDE report 23556553 ↗InjuryNov 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
PATIENT RECEIVED EBV VALVES ON (B)(6) 2025. PATIENT RETURNED TO HOSPITAL 2 DAYS AFTER DISCHARGE WITH RESPIRATORY FAILURE, CONTRA LATERAL PNEUMOTHORAX, AND WAS PLACED IN A VENTILATOR. INVESTIGATION IS ONGOING.
Patient problems: Pneumothorax; Respiratory Failure
MAUDE report 23556454 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025, THE PATIENT WHO RECEIVED A VALVE PLACEMENT ON (B)(6) 2025 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS LARGE IN SIZE AND A CHEST TUBE WAS PLACED. ON (B)(6) 2025 VALVE WITH LOT NUMBER: 507104-V7.0 WAS REMOVED. ON (B)(6) 2025, THE REMAINING TWO VALVES WERE REMOVED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025.
Patient problems: Pneumothorax
MAUDE report 23042722 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025 THE PATIENT WHO RECEIVED A VALVE PLACEMENT ON (B)(6) 2025 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS LARGE IN SIZE AND A CHEST TUBE WAS PLACED. ON (B)(6) 2025 VALVE WITH LOT NUMBER 507104-V7.0 WAS REMOVED. ON (B)(6) 2025 THE REMAINING TWO VALVES WERE REMOVED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025.
Patient problems: Pneumothorax
MAUDE report 23042674 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025 THE PATIENT WHO RECIEVED A VALVE PLACEMENT ON (B)(6) 2025 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS MODERATE IN SIZE AND A CHEST TUBE WAS PLACED ON (B)(6) 2025. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025.
Patient problems: Pneumothorax
MAUDE report 23042603 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025 THE PATIENT WHO RECEIVED A VALVE PLACEMENT ON (B)(6) 2025 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS MODERATE IN SIZE AND A CHEST TUBE WAS PLACED ON (B)(6) 2025. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025.
Patient problems: Pneumothorax
MAUDE report 23042536 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025 THE PATIENT WHO RECEIVED A VALVE PLACEMENT ON (B)(6) 2025 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS MODERATE IN SIZE AND A CHEST TUBE WAS PLACED ON (B)(6) 2025. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025.
Patient problems: Pneumothorax
MAUDE report 23042484 ↗InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON (B)(6) 2025 THE PATIENT WHO RECIEVED A VALVE PLACEMENT ON (B)(6) 2025 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS MODERATE IN SIZE AND A CHEST TUBE WAS PLACED ON (B)(6) 2025. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025.
Patient problems: Pneumothorax
MAUDE report 23042369 ↗MalfunctionMay 19, 2025Premature Activation; Device Damaged Prior to Use
UPON OPENING THE VALVE CARTRIDGE, THE VALVE WAS PARTIALLY DEPLOYED IN CARTRIDGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22043820 ↗DeathApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A BLVR PROCEDURE WAS COMPLETED INCLUDING IMPLANTATION OF FOUR VALVES (ONE VALVE IN THE RIGHT MIDDLE LOBE (RML) AND THREE IN THE RIGHT UPPER LOBE (RUL) ON (B)(6) 2025. PER THE PHYSICIAN, THE PROCEDURE DURATION LASTED FOR ABOUT ONE HOUR. ON (B)(6) 2025, ALL FOUR VALVES WERE EXPLANTED DUE TO A DECLINE IN THE PATIENT'S RESPIRATORY STATUS FOLLOWING THE PROCEDURE WHILE IN THE ICU. THE VALVES REMAINED IMPLANTED FOR A TOTAL OF 3 DAYS. ON (B)(6) 2025, IMMEDIATELY FOLLOWING THE BRONCHOSCOPY, THE PATIENT EXPERIENCED A FAILED EXTUBATION DUE TO CO[?] RETENTION AND HYPERSOMNOLENCE, REQUIRING RE-INTUBATION AND TRANSFER TO THE ICU. DESPITE VARIOUS VENTILATOR ADJUSTMENTS, THE PATIENT DEMONSTRATED VERY POOR AIR MOVEMENT. THE VALVES WERE REMOVED AFTER THREE DAYS; HOWEVER, THE PATIENT'S CONDITION DID NOT IMPROVE. THE PATIENT CONTINUED TO DETERIORATE AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2025. PER THE MEDICAL CHART, THE FOLLOWING STATEMENT WAS DOCUMENTED: "DUE TO PERSISTENCE OF VENTILATOR DEPENDENCE AND INABILITY TO WEAN PATIENT SUCCESSFULLY FROM PARALYSIS AND DEEP SEDATION, COUNSELED FAMILY THAT NEXT TREATMENT OPTION WAS TO UNDERGO TRACHEOSTOMY PLACEMENT VERSUS PURSUE COMFORT FOCUSED CARE. IN SPEAKIN
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859628 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SUBJECT HAD THREE ZEPHYR VALVES IMPLANTED IN THE RIGHT UPPER LOBE ON (B)(6) 2024. ON (B)(6) 2024, HE EXPERIENCED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2024 WITH THE CHEST TUBE IN PLACE. THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. A CHEST X-RAY SHOWED RECURRENT PNEUMOTHORAX. A NEW CHEST TUBE WAS PLACED. A CHEST X-RAY ON (B)(6) 2024 SHOWED A PLEURAL EFFUSION. PLEURAL ADHESION WAS IDENTIFIED ON (B)(6) 2024. PATIENT UNDERWENT VATS ON (B)(6) 2024. THE PNEUMOTHORAX RESOLVED ON (B)(6) 2024.
Patient problems: Pleural Effusion; Pneumothorax
MAUDE report 20859337 ↗InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD THREE ZEPHYR VALVES IMPLANTED IN THE LEFT UPPER LOBE ON (B)(6) 2024. THE PATIENT HAD A PNEUMOTHORAX AND A CHEST TUBE WAS INSERTED ON (B)(6) 2024. THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. ON (B)(6) /2024, THE PATIENT REPORTED A "SUDDEN POP" IN THEIR CHEST AND DYSPNEA. THEY WERE ADMITTED WITH A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX DID NOT RESOLVE SO A SECOND CHEST TUBE WAS INSERTED. ON (B)(6) 2024, ALL VALVES WERE EXPLANTED. TWO OF THE VALVES HAD THE ONE-WAY PORTION INVERTED. A CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE SECOND CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6)2024.
Patient problems: Pneumothorax
MAUDE report 20774967 ↗InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD EIGHT ZEPHYR VALVES IMPLANTED IN THE LEFT LOWER LOBE ON (B)(6) 2024. THE PATIENT HAD A PNEUMOTHORAX ON (B)(6) 2024 AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT'S ATRIAL FIBRILLATION FLARED. THE PATIENT ELECTED TO START HOSPICE ON (B)(6) 2024. THE PATIENT DIED AT HOME ON (B)(6) 2024. THE DOCTOR STATED THAT THE CAUSE OF DEATH AND ATRIAL FIBRILLATION WERE NOT RELATED TO COPD OR THE BLVR PROCEDURE.
Patient problems: Pneumothorax
MAUDE report 20592198 ↗InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(6) 2024, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. TREATMENT IS ONGOING. MORE INFORMATION WILL BE PROVIDED WHEN AVAILABLE.
Patient problems: Pneumothorax
MAUDE report 19659286 ↗InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SUBJECT HAD SEVEN ZEPHYR VALVES IMPLANTED IN THE LOWER LEFT LOBE ON (B)(6) 2021. ON (B)(6) 2024 THE SUBJECT WAS HOSPITALIZED FOR A LEFT PNEUMOTHORAX AND A CHEST TUBE WAS PLACED.. THE CHEST TUBE WAS REMOVED AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2024. ON (B)(6) 2024, THE SUBJECT WAS AGAIN HOSPTALIZED FOR A RECURRENT LEFT PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE TUBE WAS REMOVED AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2024.
Patient problems: Pneumothorax
MAUDE report 19494073 ↗InjuryJun 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SUBJECT HAD SEVEN ZEPHYR VALVES IMPLANTED IN THE LOWER LEFT LOBE ON (B)(6) 2021. ON (B)(6) 2024 THE SUBJECT WAS HOSPITALIZED FOR A LEFT PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE CHEST TUBE WAS REMOVED AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2024. ON (B)(6)2024, THE SUBJECT WAS AGAIN HOSPITALIZED FOR A RECURRENT LEFT PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE TUBE WAS REMOVED AND THE SUBJECT WAS DISCHARGED ON (B)(6) 2024.
Patient problems: Pneumothorax
MAUDE report 19493261 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P180002. One submission often covers many models, so check the product and lot details in each record.
- Z-0235-2024 · Aug 31, 2023 · Open, ClassifiedZephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
Other Valve, Pulmonary devices
- Zephyr Endobronchial Valve EBV-TS-4.0Pulmonx Corporation · Valve, Pulmonary36 deaths387 reports
- Zephyr Endobronchial Valve EBV-TS-5.5Pulmonx Corporation · Valve, Pulmonary31 deaths282 reports
- Zephyr Endobronchial Valve EBV-TS-5.5-LPPulmonx Corporation · Valve, Pulmonary1 recall24 deaths205 reports
- Spiration Valve System SVS-V9-00Gyrus Acmi, Llc · Valve, Pulmonary1 recall5 deaths100 reports
- Spiration Valve System SVS-V7-00Gyrus Acmi, Llc · Valve, Pulmonary3 deaths84 reports
- Zephyr Delivery Catheter EDC-TS-4.0-JPulmonx Corporation · Valve, Pulmonary32 reports
- Spiration Valve System SVS-V6-00Gyrus Acmi, Llc · Valve, Pulmonary1 death31 reports
- Zephyr Delivery Catheter EDC-TS-5.5-DMPulmonx Corporation · Valve, Pulmonary23 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page