Zephyr Delivery CatheterRecalls & 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
- Adverse event reports
- 72
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 4 models of Zephyr Delivery Catheter by Pulmonx Corporation in the FDA's device registry (GUDID). Together they are named in 72 adverse event reports in the FDA's MAUDE database, received between Dec 20, 2018 and Jul 27, 2026 — classified as 2 injuries, 70 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (70 reports).
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
Most reported Zephyr Delivery Catheter problems
Device problems
- Material Split, Cut or Torn70
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Known Impact Or Consequence To Patient19
- Hemoptysis1
- Pneumothorax1
- Pulmonary Embolism1
- Respiratory Acidosis1
Zephyr Delivery Catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Zephyr Delivery Catheter EDC-TS-4.0-JValve, Pulmonary32 reports
- Zephyr Delivery Catheter EDC-TS-5.5-DMValve, Pulmonary23 reports
- Zephyr Delivery Catheter EDC-TS-4.0Valve, Pulmonary15 reports
- Zephyr Delivery Catheter EDC-TS-5.5Valve, Pulmonary2 reports
Recent Zephyr Delivery Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Material Split, Cut or Torn
An incident occurred during a valve placement procedure where one of the delivery catheter's wings broke off in the patient. The wing was located and removed from the patient. The following device deficiency was not associated with an adverse event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50019396 ↗MalfunctionJun 4, 2026Material Split, Cut or Torn
TWO INCIDENTS OCCURRED DURING A VALVE PLACEMENT PROCEDURE, TWO SEPARATE DELIVERY CATHETERS HAD A SIZING WING BREAK OFF IN THE PATIENT AFTER MEASUREMENT OF THE AIRWAY. ALL WINGS WERE REMOVED FROM THE PATIENT USING SUCTION. THE FOLLOWING DEVICE DEFICIENCY WAS NOT ASSOCIATED WITH AN ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399408 ↗MalfunctionJun 4, 2026Material Split, Cut or Torn
TWO INCIDENTS OCCURRED DURING A VALVE PLACEMENT PROCEDURE, TWO SEPARATE DELIVERY CATHETERS HAD A SIZING WING BREAK OFF IN THE PATIENT AFTER MEASUREMENT OF THE AIRWAY. ALL WINGS WERE REMOVED FROM THE PATIENT USING SUCTION. THE FOLLOWING DEVICE DEFICIENCY WAS NOT ASSOCIATED WITH AN ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25399407 ↗MalfunctionFeb 5, 2026Material Split, Cut or Torn
AN INCIDENT OCCURRED DURING A VALVE PLACEMENT PROCEDURE WHERE PART OF THE DELIVERY CATHETER'S WING BROKE OFF IN THE PATIENT AND WAS REMOVED WITH A GRASPER. THE FOLLOWING DEVICE DEFICIENCY WAS NOT ASSOCIATED WITH AN ADVERSE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24274078 ↗MalfunctionMar 26, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS SIZING THE AIRWAY, ONE OF THE WINGS FELL OFF THE CATHETER. THE WING WAS FOUND IN THE LEFT UPPER LUNG AIRWAY WHERE IT WAS REMOVED FROM THE PATIENT'S AIRWAY AND THE CASE WAS COMPLETED. PRODUCT WAS THROWN AWAY AFTER AND NOT ABLE TO BE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21702156 ↗InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SUBJECT HAD FOUR ZEPHYR VALVES PLACED IN THE LEFT LOWER LOBE (LLL) ON (B)(6) 2024. ON (B)(6) 2025 A SECONDARY BRONCHOSCOPY-1 WAS PERFORMED WHERE 4 INDEX VALVES WERE REMOVED AND 5 VALVES WERE IMPLANTED. POST-PROCEDURE THE PATIENT DEMONSTRATED ACUTE RESPIRATORY ACIDOSIS AND HYPERCAPNIC RESPIRATORY FAILURE WITH TACHYPNEA, TACHYCARDIA, AND HYPERCAPNEA. A CHEST X-RAY SHOWED THERE WAS A LARGE RIGHT PNEUMOTHORAX WHERE A CHEST TUBE WAS INSERTED AND THE PATIENT'S TACHYCARDIA, TACHYPNEA, AND HYPERCAPNEA RAPIDLY RESOLVED. RESPIRATORY ACIDOSIS WAS RESOLVED ON (B)(6)2025. ON (B)(6) 2025 A SECONDARY BRONCHOSCOPY-2 WAS PERFORMED WHERE ONE VALVE WAS REMOVED DUE TO THE WORSENING AIRLEAK/PNEUMOTHORAX. A CT WAS TAKEN THAT SHOWED SEGMENTAL PULMONARY EMBOLISM WHERE THE PATIENT WAS STARTED ON ANTICOAGULATION WITH HEPARIN INFUSION WHICH WAS SUPRATHERAPEUTIC DURING MONITORING. THIS LED TO HEMOPTYSIS THAT IMPROVED WITH CESSATION OF ANTICOAGULATION WHERE HEMOPTYSIS WAS RESOLVED ON (B)(6) 2025. ALL VALVES WERE REMOVED ON (B)(6)2025 WITH RAPID RESOLUTION OF THE LEAK. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025 WITH RESOLUTION OF THE PULMONARY EMBOLISM.
Patient problems: Hemoptysis; Pneumothorax; Pulmonary Embolism; Respiratory Acidosis
MAUDE report 21668649 ↗MalfunctionFeb 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ONE OF THE SIZING WINGS BROKE OFF OF THE CATHETER. THE WING WAS FOUND AND RETRIEVED. THE PROCEDURE CONTINUED WITH A NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21370634 ↗MalfunctionOct 7, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ONE OF THE SIZING WINGS BROKE OFF DURING CATHETER REMOVAL FROM THE FIRST AIRWAY TO BE SIZED. THE WING WAS FOUND AND RETRIEVED. THE PROCEDURE CONTINUED WITH A NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391464 ↗MalfunctionJun 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ONE OF THE SIZING WINGS BROKE OFF DURING SIZING OF THE FIRST AIRWAY. THE WING WAS FOUND AND RETRIEVED. THE PROCEDURE CONTINUED WITH A NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590369 ↗MalfunctionMay 24, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
THE CATHETER WAS USED FOR ONE SUCCESSFUL DEPLOYMENT OF A VALVE. IT WAS THEN NOTED THAT ONE OF THE SIZING WINGS WAS MISSING. THE WING WAS FOUND IN THE FLUID CONTAINER. THE PROCEDURE CONTINUED WITH A NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19397535 ↗MalfunctionMay 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
UPON PASSING THE CATHETER THROUGH THE BRONCHOSCOPE AND INTO THE LUNGS, IT WAS NOTED THAT ONE OF THE SIZING WINGS WAS MISSING. THE WING WAS FOUND IN THE MAIN STEM AND REMOVED FROM THE PATIENT. THE PROCEDURE CONTINUED WITH A NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19344932 ↗MalfunctionOct 23, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DURING A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE ON (B)(6) 2023 WITH ZEPHYR VALVES, ONE SIZING WING ON THE ZEPHYR 5.5 DM ENDOBRONCHIAL DELIVERY CATHETER (EDC) DETACHED WHILE MEASURING AND SIZING THE AIRWAYS. THE SIZING WING WAS RECOVERED AND REMOVED FROM THE PATIENT. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17986808 ↗MalfunctionJun 13, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DURING A PROCEDURE TO IMPLANT ZEPHYR VALVES, THE DOCTOR NOTICED, THAT ONE OF THE SIZING WINGS BECAME DETACHED FROM THE CATHETER. THE WING WAS REMOVED WITH GRASPERS. THE PROCEDURE CONTINUED WITH A NEW CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17121931 ↗MalfunctionJun 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DURING A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE ON (B)(6) 2023 WITH ZEPHYR VALVES, ONE SIZING WING ON THE ZEPHYR 5.5 DUAL MARK ENDOBRONCHIAL DELIVERY CATHETER (EDC) DETACHED DURING THE PROCEDURE AND HAD TO BE RETRIEVED WITH FORCEPS. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A REPLACEMENT CATHETER WITH NO ADDITIONAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17091355 ↗MalfunctionMay 9, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
DURING A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE ON (B)(6) 2023 WITH ZEPHYR VALVES, ONE SIZING WING ON THE ZEPHYR 5.5 DUAL MARK ENDOBRONCHIAL DELIVERY CATHETER (EDC) DETACHED WHILE PLACING THE FIRST VALVE IN THE LEFT UPPER LOBE (POSTERIOR SEGMENT) DURING THE SECOND INSERTION OF THE CATHETER. THE DETACHED SIZING WING WAS REMOVED WITH FORCEPS. A SECOND WING STARTED TO DETACH, AND THE CATHETER WAS REMOVED AND REPLACED WITH A NEW ZEPHYR ENDOBRONCHIAL DELIVERY CATHETER. THE SECOND DETACHED WING WAS REMOVED FROM THE PATIENT. THE DOCTOR WAS ABLE TO SUCCESSFULLY COMPLETE PROCEDURE WITH NO ADDITIONAL COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16899176 ↗
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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