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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00811907030720), received between Jan 2, 2019 and Aug 7, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2019, THE PATIENT UNDERWENT A BRONCHOSCOPY PROCEDURE WITH ZEPHYR VALVE PLACEMENT IN THE LEFT LOWER LOBE (LUL) BASED ON CT. A CHARTIS ASSESSMENT WAS PERFORMED IN THE LLL AND GAVE A NEGATIVE COLLATERAL VENTILATION READING. A ZEPHYR 5.5 ENDOBRONCHIAL DELIVERY CATHETER (EDC) WAS USED TO SIZE THE AIRWAYS AND DEPLOY A ZEPHYR VALVE. DURING THE VALVE SIZING PORTION OF THE CASE, ONE OF THE SIZING WINGS ON THE CATHETER FELL OFF INSIDE THE PATIENT. THE LOOSE SIZING WING WAS FOUND AND SUCTIONED OUT THROUGH THE BRONCHOSCOPE. A REPLACEMENT CATHETER WAS USED FOR THE REST OF THE CASE AND FIVE VALVES WERE PLACED IN THE LLL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8869489 ↗
• MalfunctionJan 2, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2018, THE PATIENT UNDERWENT A BRONCHOSCOPY FOR CHARTIS ASSESSMENT AND ZEPHYR VALVE INSERTION FOR A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE. DURING THE CHARIS ASSESSMENT, IT WAS DETERMINED THAT THE PATIENT WAS NEGATIVE FOR COLLATERAL VENTILATION IN HIS RIGHT LOWER LOBE AND THEREFORE, WOULD RECEIVE ZEPHYR VALVES. THE PATIENT RECEIVED A TOTAL OF 5 ZEPHYR VALVES IN HIS RIGHT LOWER LOBE. DURING THE PROCEDURE, A ZEPHYR 5.5 ENDOBRONCHIAL DELIVERY CATHETER WAS INSERTED TO MEASURE THE SUPERIOR SEGMENT OF THE RIGHT LOWER LOBE. AS THE DELIVERY CATHETER CAME OUT OF THE BRONCHOSCOPE, ONE OF THE FOUR SIZING WINGS (ALSO CALLED DIAMETER GAUGES) FROM THE DELIVERY CATHETER HAD BECOME DETACHED AND WAS VISUALIZED IN THE AIRWAY. THE DETACHED SIZING WING WAS REMOVED WITH FORCEPS, AND THE ZEPHYR 5.5 ENDOBRONCHIAL DELIVERY CATHETER DETERMINED THAT THE ZEPHYR 5.5 ENDOBRONCHIAL VALVE WOULD BE THE INCORRECT SIZE FOR THE AIRWAY DIAMETER. AS A RESULT, THE PHYSICIAN SWITCHED TO THE SMALLER SIZED ZEPHYR 4.0 ENDOBRONCHIAL DELIVERY CATHETER FOR THE REMAINDER OF THE PROCEDURE WITH NO ISSUES. PATIENT IS DOING WELL AND STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8210747 ↗

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