Zephyr Delivery Catheter EDC-TS-5.5-DMRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00811907031222), received between Dec 9, 2019 and Jun 4, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (22 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 23 most recent of 23 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 25399407 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 25, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A PROCEDURE TO SIZE THE AIRWAYS FOR PLACEMENT OF THE ZEPHYR VALVES, THE DOCTOR NOTICED THAT ONE OF THE SIZING WINGS BECAME DETACHED FROM THE CATHETER. THE WING WAS REMOVED WITH SUCTION. THE PROCEDURE CONTINUED WITH A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16812116 ↗
• MalfunctionDec 22, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  WHEN REMOVED FROM THE PACKAGING, A WING ON THE 5.5-DM EDC WAS CLEARLY SMUSHED UP AGAINST THE CATHETER. WHEN IT WAS ENTERED INTO THE BRONCHOSCOPE, THE WING CAME OFF OF THE EDC. THE WING WAS RETRIEVED THROUGH THE SUCTION TUBING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16040304 ↗
• MalfunctionDec 6, 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 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 15927048 ↗
• MalfunctionAug 24, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, THE PATIENT HAD ZEPHYR VALVES IMPLANTED. DURING THE PROCEDURE, THE EDC HAD DIFFICULTY PASSING THROUGH THE BRONCHOSCOPE. ANOTHER BRONCHOSCOPE WAS USED AND THE EDC WAS ABLE TO PASS SMOOTHER THROUGH THE WORKING CHANNEL. AFTER THE FIRST ZEPHYR VALVE WAS DEPLOYED, IT WAS NOTICED THAT ONE OF THE SIZING WINGS FROM THE CATHETER WAS TORN AND ALMOST COMING OFF. THE CATHETER WAS ROTATED TO VIEW THROUGH THE SCOPE AND THE SIZING WING TORE OFF INSIDE THE PATIENT. THE SIZING WING WAS EXTRACTED WITH FORCEPS AND THE PROCEDURE CONTINUED WITH A DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15283566 ↗
• MalfunctionJun 16, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  DURING A ZEPHYR VALVE PROCEDURE, A ZEPHYR 5.5 EDC WAS USED TO SIZE. IT WAS NOTICED THAT ONE OF THE SIZING WINGS WAS SHEARED OFF AND SMALL FRAGMENTS OF IT COULD BE SEEN INSIDE THE PATIENT. THE SHEARED WING WAS RETRIEVED. A NEW 5.5 EDC WAS USED INSTEAD WITHOUT ISSUE. PRODUCT WAS DISPOSED OF AND NOT RETURNED TO PULMONX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710474 ↗
• MalfunctionApr 18, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, THE PHYSICIAN WAS USING THE CATHETER TO MEASURE THE AIRWAYS. ONE OF THE LARGE 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 14138547 ↗
• MalfunctionMar 31, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2022, A LARGE SIZING WING 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 13971706 ↗
• MalfunctionDec 22, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, A SMALL SIZING WING FROM THE CATHETER SHEARED OFF UPON FIRST INSERTION INTO THE BRONCHOSCOPE. THE SIZING WING WAS EXTRACTED FROM THE PATIENT VIA SCOPE SUCTION AND THE PROCEDURE CONTINUED WITH A DIFFERENT CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13066443 ↗
• MalfunctionDec 6, 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 USED A ZEPHYR 5.5 DUAL MARK ENDOBRONCHIAL DELIVERY CATHETER WHICH WAS INSERTED THROUGH THE BRONCHOSCOPE TO SIZE THE AIRWAYS, AND THEN WAS REMOVED TO LOAD A VALVE. QUICKLY AFTER INSERTING THE CATHETER A SECOND TIME THROUGH THE BRONCHOSCOPE CHANNEL, IT WAS NOTICED THAT ONE OF THE LARGER SIZING WINGS WAS DETACHED. THE SIZING WING WAS REMOVED AND WAS NOT LEFT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933788 ↗
• MalfunctionJun 4, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2021, DURING VALVE INSERTION, A SIZING WING OF THE DELIVERY CATHETER BROKE IN THE PATIENT. THE SIZING WING WAS SUCCESSFULLY REMOVED, AND A NEW EDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11943599 ↗
• MalfunctionOct 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2020, THE DISTAL TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. GRASPERS WERE USED TO REMOVE THE FOREIGN OBJECT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10759585 ↗
• MalfunctionFeb 5, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2020, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE WITH ZEPHYR VALVES. DURING THE PROCEDURE, ONE OF THE SIZING WINGS ON THE ZEPHYR 5.5 DUAL MARK ENDOBRONCHIAL DELIVERY CATHETER FELL OFF INSIDE THE PATIENT. THE LOOSE SIZING WING WAS IMMEDIATELY RETRIEVED FROM THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9671992 ↗
• MalfunctionJan 7, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, THE PATIENT UNDERWENT A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE WITH ZEPHYR VALVES. DURING THE PROCEDURE WHILE SIZING THE AIRWAY, ONE OF THE SIZING WINGS ON THE ZEPHYR 5.5 DUAL MARK ENDOBRONCHIAL DELIVERY CATHETER FELL OFF INSIDE THE AIRWAY. THE LOOSE SIZING WING INSIDE THE AIRWAY WAS LOCATED AND REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9560993 ↗
• MalfunctionJan 6, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, THE PHYSICIAN LOADED A ZEPHYR 5.5-LP ENDOBRONCHIAL VALVE INTO A ZEPHYR 5.5 DUALMARK ENDOBRONCHIAL DELIVERY CATHETER, WHICH WAS THEN PASSED THROUGH A BRONCHOSCOPE AND DEPLOYED IN THE POSTERIOR SEGMENT OF THE PATIENT'S LEFT UPPER LOBE (LUL). AFTER DEPLOYMENT, THE PHYSICIAN PULLED THE ZEPHYR CATHETER OUT OF THE BRONCHOSCOPE. HE THEN PASSED THE ZEPHYR CATHETER BACK DOWN WITHOUT A ZEPHYR VALVE LOADED TO MEASURE THE ANTERIOR SEGMENT OF THE LUL. AS THE ZEPHYR CATHETER EXITED THE BRONCHOSCOPE WORKING CHANNEL, A SIZING WING BECAME DETACHED AND WAS VISUALIZED LOOSE IN THE AIRWAY. THE PHYSICIAN SUCTIONED THE SIZING WING FRAGMENT THROUGH THE BRONCHOSCOPE AND AN AIRWAY INSPECTION SHOWED NO REMAINING FOREIGN BODIES. ON JAN. 3, 2020, THE ZEPHYR CATHETER WAS RETURNED TO PULMONX. AT THE TIME OF THIS REPORT, A PRODUCT INVESTIGATION IS ONGOING AND A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9554498 ↗
• MalfunctionDec 9, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, PATIENT UNDERWENT BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH ZEPHYR ENDOBRONCHIAL VALVE (EBV) PLACEMENT. WHILE THE PHYSICIAN WAS MEASURING THE AIRWAYS FOR VALVE SIZING WITH THE ZEPHYR 5.5 DUAL MARK ENDOBRONCHIAL DELIVERY CATHETER (EDC), ONE OF THE SIZING WINGS WAS SEEN IN THE PATIENT'S AIRWAY. THE DAMAGED ZEPHYR 5.5 DUAL MARK EDC WAS OPENED USING PROPER TECHNIQUE AND UNDER THE TERRITORY MANAGER'S OBSERVATION. GEL LUBRICATION WAS APPLIED PRIOR TO INSERTION INTO THE WORKING CHANNEL OF THE BRONCHOSCOPE, BUT SIGNIFICANT RESISTANCE WAS EVIDENT AS THE CATHETER PASSED THROUGH THE BOTTOM OF THE BRONCHOSCOPE'S WORKING CHANNEL AND INTO THE PATIENT'S AIRWAY. THE TORN OFF WING WAS REMOVED VIA SUCTION WITHOUT INCIDENT, AND A REPLACEMENT DELIVERY CATHETER WAS OPENED FOR USE DURING THE REST OF THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9440962 ↗

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