Zephyr Delivery Catheter EDC-TS-4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00811907030522), received between Nov 21, 2019 and Jun 4, 2026 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (14 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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 17, 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 4.0 ENDOBRONCHIAL DELIVERY CATHETER (EDC) CAME OFF AFTER SUCCESSFUL AIRWAY SIZING AND LOADING OF VALVE. BRONCHOSCOPIC INSPECTION DID NOT LEAD TO LOCATING THE ALLEGED MISSING SIZING WING. SUCTION EVACUATES TO A WALL MOUNTED SYSTEM SO INSPECTION OF SUCTIONED MATERIAL WAS NOT POSSIBLE. ANOTHER NEW EDC WAS SUBSEQUENTLY USED, AND THE CASE PROCEEDED WITH NO FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401026 ↗
• MalfunctionOct 5, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE ON (B)(6) 2022 WITH ZEPHYR VALVES, ONE SIZING WING ON THE ZEPHYR 4.0 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 15544470 ↗
• MalfunctionJul 28, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, THE PATIENT HAD ZEPHYR VALVES IMPLANTED. DURING THE PROCEDURE, ONE OF THE SIZING WINGS FROM THE CATHETER CAME OFF WHILE INSIDE THE PATIENT. THE SIZING WING WAS EXTRACTED AND THE PROCEDURE CONTINUED WITH A DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15126262 ↗
• MalfunctionApr 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A ZEPHYR VALVE PROCEDURE FOR A LUL, A ZEPHYR EDC 4.0 WAS USED TO SIZE. ONCE INSERTED INTO THE BRONCHOSCOPE CHANNEL, IT WAS NOTICED THE SIZING WINGS WERE SHEARED OFF MAKING THE PRODUCT UNUSABLE. THE SHEARED WING WAS RETRIEVED. A 4.0J EDC WAS USED INSTEAD WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14058054 ↗
• MalfunctionMar 23, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PATIENT HAD ZEPHYR VALVES PLACED DURING A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE ON (B)(6) 2022. ONE OF THE LARGE SIZING WINGS ON THE ZEPHYR 4.0 ENDOBRONCHIAL DELIVERY CATHETER (EDC) BROKE OFF AFTER THE INITIAL INSERTION THROUGH THE WORKING CHANNEL OF THE BRONCHOSCOPE. THE SIZING WING WAS REMOVED FROM THE AIRWAY. AN ADDITIONAL EDC WAS OPENED TO COMPLETE THE PROCEDURE AND THERE WERE NO OTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13863535 ↗
• MalfunctionFeb 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  THE PATIENT HAD TWO ZEPHYR VALVES PLACED IN HER RIGHT MIDDLE LOBE (RML) DURING A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE ON (B)(6) 2022. FOLLOWING SIZING OF THE MEDIAL SEGMENT OF THE RML, THE 4.0 ENDOBRONCHIAL DELIVERY CATHETER (EDC) WAS REINSERTED TO PLACE THE FIRST VALVE. WHILE DEPLOYING THAT FIRST VALVE, IT WAS NOTED THAT ONE LONG SIZING WING OF THE EDC HAD BECOME DETACHED. FOLLOWING REMOVAL OF THE EDC FROM THE BRONCHOSCOPE, THE DETACHED SIZING WING WAS REMOVED WITH FORCEPS. AS THE PHYSICIAN HAD NOT YET FINISHED SIZING THE LATERAL AIRWAY AND COMPLETED THE PROCEDURE, AN ADDITIONAL EDC WAS OPENED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE WITHOUT FURTHER INCIDENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560287 ↗
• MalfunctionSep 20, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH ZEPHYR VALVES. THE PHYSICIAN HAD USED THE ZEPHYR 4.0 ENDOBRONCHIAL DELIVERY CATHETER TO SIZE AIRWAYS IN THE LEFT UPPER LOBE (LUL) AND DELIVER VALVES. A SMALL PIECE OF THE SIZING WING FROM THE CATHETER BROKE OFF AND WAS REMOVED FROM THE PATIENT WITH GRASPERS. THE PHYSICIAN USED A NEW CATHETER AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE CATHETER WAS SET ASIDE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION BUT WAS DISCARDED BY A NURSE IN THE ROOM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12498080 ↗
• MalfunctionSep 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH ZEPHYR VALVES. THE PHYSICIAN HAD USED THE ZEPHYR 4.0 ENDOBRONCHIAL DELIVERY CATHETER TO SIZE AIRWAYS IN THE RIGHT UPPER LOBE (RUL) AND RIGHT MIDDLE LOBE (RML) AND DELIVER THREE VALVES. ONE OF THE SIZING WINGS OF THE CATHETER WAS DETACHED, AND THE FRAGMENT WAS NOT FOUND. IT WAS NOT CLEAR IF THE SIZING WING FELL OFF INSIDE THE PATIENT, WAS INSIDE OF THE BRONCHOSCOPE AND SUBSEQUENTLY REMOVED, OR IF IT WAS REMOVED FROM THE PATIENT WHILE MUCUS AND BLOOD WERE CLEARED FROM THE AIRWAY. THE PHYSICIAN HAD DIFFICULTY ACCESSING THE APICAL SEGMENT OF THE RUL. THE PHYSICIAN USED A NEW ZEPHYR 4.0-J CATHETER AND WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457153 ↗
• MalfunctionApr 16, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH ZEPHYR VALVES. DURING THE DELIVERY OF A ZEPHYR VALVE, THE PHYSICIAN PUSHED A ZEPHYR 4.0 EDC OUTSIDE OF THE BRONCHOSCOPE. WHEN HE PULLED THE ZEPHYR EDC BACK INTO THE BRONCHOSCOPE, A SIZING WING DETACHED FROM THE CATHETER IN THE AIRWAY OF THE LUNG. AFTER PULLING OUT THE ZEPHYR EDC FROM THE BRONCHOSCOPE AND TRYING AGAIN, TWO MORE SIZING WINGS BECAME DETACHED IN THE AIRWAY OF THE LUNG. ALL THE DETACHED WINGS WERE IMMEDIATELY RETRIEVED WITH FORCEPS. THE ZEPHYR EDC WAS GETTING STUCK AT THE HUB WHEN GETTING PULLED BACK INTO THE BRONCHOSCOPE. A NEW ZEPHYR EDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY SUBSTANTIAL DELAY AND THERE WAS NO IMPACT ON THE PROCEDURE OR OUTCOME OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11681847 ↗
• MalfunctionMar 18, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH ZEPHYR VALVES. ONE OF THE LARGE SIZING WINGS OF THE ZEPHYR 4.0 ENDOBRONCHIAL DELIVERY CATHETER (EDC) BROKE OFF IN FRONT OF THE BRONCHOSCOPE CAMERA AND WAS SUCCESSFULLY REMOVED WITH FORCEPS. THERE WAS NO ADVERSE EFFECT ON THE CASE OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11517534 ↗
• MalfunctionJan 7, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2020, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH ZEPHYR VALVES. THE SIZING WING OF THE ZEPHYR 4.0 ENDOBRONCHIAL DELIVERY CATHETER (EDC) BROKE OFF AND WAS VISIBLE ON THE PATIENT'S AIRWAY WALL. THE FRAGMENT WAS REMOVED WITH FORCEPS AND THE PHYSICIAN CONTINUED THE PROCEDURE SUCCESSFULLY USING A NEW EDC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 11135962 ↗
• MalfunctionNov 21, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE. A ZEPHYR 4.0 ENDOBRONCHIAL DELIVERY CATHETER (EDC) WAS USED TO SIZE THE AIRWAYS AND DEPLOY A ZEPHYR VALVE. ONE OF THE SIZING WINGS ON THE CATHETER BROKE OFF INSIDE THE PATIENT AND WAS EASILY SEEN AND IMMEDIATELY RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9359750 ↗

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, Classified
  Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP