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

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00811907030621), received between Dec 20, 2018 and Jul 27, 2026 — classified as 1 injury, 31 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (32 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 25 most recent of 32 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionFeb 7, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A PROCEDURE TO PLACE ZEPHYR VALVES, THE DOCTOR NOTICED THAT ONE OF THE LARGER SIZING WINGS BECAME DETACHED FROM THE CATHETER. HE TRIED TO REMOVE THE WING WITH GRASPERS BUT LOST SIGHT OF THE WING. THE PROCEDURE CONTINUED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315231 ↗
• MalfunctionOct 18, 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 J 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 15626204 ↗
• MalfunctionSep 28, 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-J ENDOBRONCHIAL DELIVERY CATHETER (EDC) FELL OFF WHILE SIZING THE APICAL SEGMENT OF THE RIGHT UPPER LOBE. THE SIZING WING WAS RECOVERED AND REMOVED FROM THE BODY. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499159 ↗
• MalfunctionSep 20, 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-J ENDOBRONCHIAL DELIVERY CATHETER (EDC) FELL OFF DURING THE PROCEDURE. THE SIZING WING WAS RETRIEVED SUCCESSFULLY WITH NO PATIENT CONSEQUENCES. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15457350 ↗
• MalfunctionSep 14, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15419027 ↗
• MalfunctionJun 30, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A ZEPHYR VALVE PROCEDURE, A ZEPHYR 4.0 J EDC WAS USED TO SIZE. IT WAS NOTICED THAT ONE OF THE SIZING WINGS WAS BROKEN OFF AND IT COULD BE SEEN INSIDE THE PATIENT'S AIRWAY. THE BROKEN WING WAS SAFELY RETRIEVED USING BIOPSY FORCEPS. THE SIZING PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW 4.0 J EDC AND THE VALVE WAS PLACED WITHOUT ANY OTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881175 ↗
• MalfunctionJun 29, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A ZEPHYR VALVE PROCEDURE, A ZEPHYR 4.0 J EDC WAS USED TO DEPLOY A VALVE. FOLLOWING THE DEPLOYMENT, IT WAS NOTICED THAT ONE OF THE SIZING WINGS WAS MISSING. THE MISSING WING WAS NOT NOTICED INSIDE THE AIRWAYS. THE VALVE DEPLOYMENT PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14861895 ↗
• MalfunctionJan 6, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, A LARGE SIZING WING FROM THE CATHETER SHEARED OFF UPON RETRACTIOIN FROM THE MAIN BRONCHUS. THE SIZING WING WAS EXTRACTED FROM THE PATIENT VIA FORCEPS AND THE PROCEDURE CONTINUED WITH A DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13179264 ↗
• MalfunctionNov 10, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, UPON INITIAL MEASURING OF THE AIRWAY, THE PHYSICIAN NOTICED A PIECE OF THE SIZING WING SHEARED OFF. THE SIZING WING WAS EXTRACTED FROM THE PATIENT AND THE PROCEDURE CONTINUED WITH A DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788307 ↗
• MalfunctionOct 25, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, A PIECE OF THE SMALL SIZING WING WAS VISIBLE INSIDE THE PATIENT THROUGH THE BRONCHOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12694024 ↗
• MalfunctionAug 23, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, WHILE SIZING THE APICAL SEGMENT OF THE LEFT UPPER LOBE, A SIZING WING OF THE DELIVERY CATHETER BROKE IN THE PATIENT. THE SIZING WING WAS SUCCESSFULLY REMOVED USING FORCEPS, AND A NEW EDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12357054 ↗
• MalfunctionJul 27, 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-J ENDOBRONCHIAL DELIVERY CATHETER TO SIZE THE AIRWAY AND DELIVER A VALVE. ONE OF THE LARGER SIZING WINGS DETACHED FROM THE CATHETER, AND THE PHYSICIAN RETRIEVED IT FROM THE PATIENT WITH A SET OF GRASPERS. A NEW DELIVERY CATHETER WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12230020 ↗
• MalfunctionJul 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. THE PHYSICIAN HAD USED THE ZEPHYR 4.0-J CATHETER TO SIZE THE AIRWAY, AND THEN A 4.0-LP VALVE WAS LOADED INTO THE CATHETER. AFTER LOADING THE VALVE INTO THE CATHETER, THEY NOTICED ONE OF THE SIZING WINGS ON THE CATHETER WAS MISSING. THE VALVE WAS DEPLOYED, AND THEN A NEW DELIVERY CATHETER WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL DETAILS REGARDING THE LOCATION OF THE SIZING WING AND/OR ITS RETRIEVAL HAVE BEEN REQUESTED FROM THE PHYSICIAN, BUT HAVE NOT YET BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186708 ↗
• MalfunctionMay 27, 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 FOR THE RIGHT UPPER LOBE. A ZEPHYR 4.0-J ENDOBRONCHIAL DELIVERY CATHETER (EDC) WAS INSERTED, AND ONCE VISUALIZED, IT WAS NOTICED THAT ONE LARGE SIZING WING SHEARED OFF. THE DAMAGED DEVICE WAS SUCCESSFULLY REMOVED AND THE DETACHED WING WAS REMOVED WITH FORCEPS. A NEW ZEPHYR 4.0-J EDC WAS USED TO COMPLETE THE PROCEDURE UNEVENTFULLY, WITHOUT ANY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11898744 ↗
• MalfunctionMay 17, 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. WHEN ATTEMPTING TO PLACE A VALVE, THE PHYSICIAN NOTICED THAT ONE OF THE SIZING WINGS OF THE ZEPHYR 4.0-J ENDOBRONCHIAL DELIVERY CATHETER (EDC) HAD FALLEN OFF. THE SIZING WING WAS SUCCESSFULLY REMOVED WITH BIOPSY FORCEPS AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THE PATIENT TOLERATED THE PROCEDURE WITHOUT INCIDENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838030 ↗
• MalfunctionMay 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, WHILE SIZING THE LB6 AIRWAY WITH EDC 4.0-J CATHETER, A SIZING TAB FELL OFF THE EDC INTO THE AIRWAY WHEN THE CATHETER WAS PULLED INTO THE BRONCHOSCOPE. THE SIZING TAB WAS REMOVED FROM AIRWAY VIA BRONCHOSCOPE SUCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11773762 ↗
• MalfunctionMar 11, 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 SMALL SIZING WINGS OF THE ZEPHYR 4.0-J ENDOBRONCHIAL DELIVERY CATHETER (EDC) BROKE OFF WHILE MEASURING AN AIRWAY. IT WAS SUCCESSFULLY REMOVED WITH FORCEPS AND DISCARDED. THERE WAS NO ADVERSE EFFECT ON THE CASE OR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467124 ↗
• MalfunctionAug 26, 2020Material 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. WHILE ATTEMPTING TO INSERT THE ZEPHYR 4.0-J ENDOBRONCHIAL DELIVERY CATHETER (EDC) INTO AN AIRWAY THROUGH THE BRONCHOSCOPE WHILE THE BRONCHOSCOPE WAS SEVERELY ARTICULATED, THE EDC MET RESISTANCE AND WAS EVENTUALLY FORCED INTO THE AIRWAY. ONCE THE EDC ENTERED THE AIRWAY, IT WAS OBSERVED THAT A SMALL PIECE OF THE HOUSING ON THE DISTAL END HAD BROKEN AWAY FROM THE CATHETER. THE EDC WAS REMOVED AND THEY OPTED TO USE A NEW ZEPHYR 4.0-J EDC. THE TERRITORY MANAGER REMINDED THE PHYSICIAN AND SUPPORT TEAM TO ADVANCE THE EDC TO THE END OF THE BRONCHOSCOPE PRIOR TO ARTICULATING THE BRONCHOSCOPE. THERE WERE NO FURTHER ISSUES DURING THE PROCEDURE. THE BROKEN FRAGMENT WAS NOT LOCATED OR RETRIEVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10455217 ↗
• MalfunctionAug 4, 2020Material 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. DURING AIRWAY SIZING USING THE ZEPHYR 4.0-J ENDOBRONCHIAL DELIVERY CATHETER (EDC), SMALL SIZING WING FRAGMENTS HAD BECOME DETACHED AND WERE NOTICED IN THE AIRWAY. THESE WERE PROMPTLY SUCTIONED OUT, THE EDC WAS REMOVED, AND A NEW ZEPHYR 4.0-J EDC WAS USED FOR THE REMAINDER OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10365306 ↗
• MalfunctionJul 14, 2020Material 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. ONE OF THE SIZING WINGS OF THE ZEPHYR 4.0-J ENDOBRONCHIAL DELIVERY CATHETER (EDC) DETACHED DURING THE PROCEDURE AND WAS DEPOSITED INTO THE PATIENT'S AIRWAY. THE PIECE WAS PROMPTLY REMOVED FROM THE PATIENT, AND A DIFFERENT ZEPHYR 4.0-J EDC WAS OPENED AND USED FOR THE REMAINDER OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10273992 ↗
• MalfunctionFeb 13, 2020Material 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. ONE OF THE SIZING WINGS OF THE ZEPHYR 4.0-J ENDOBRONCHIAL DELIVERY CATHETER CAME OFF WHILE DEPLOYING A ZEPHYR 4.0 VALVE INTO THE APICAL SEGMENT OF THE RIGHT UPPER LOBE (RUL). THE DETACHED SIZING WING BECAME STUCK NEXT TO THE VALVE IN THE AIRWAY, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE SIZING WING WITH RAT TOOTH GRASPERS. THE VALVE WAS EXPLANTED IN ORDER TO RETRIEVE THE DETACHED SIZING WING WHICH WAS SUCCESSFULLY REMOVED. AFTERWARDS, ANOTHER ZEPHYR 4.0 VALVE WAS SUCCESSFULLY IMPLANTED AS A REPLACEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9707222 ↗

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