Zephyr Endobronchial Valve EBV-TS-4.0Recalls & reported problems

Summary

The FDA's MAUDE database contains 387 adverse event reports that list this exact device (DI 00811907030126), received between Nov 21, 2018 and Sep 25, 2026 — classified as 36 deaths, 349 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (10 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 387 reports, in the reporter's own words as published by the FDA.

• DeathSep 25, 2026Insufficient Device Problem Information

  The patient underwent a BLVR revision procedure. The patient died (b)(6) 2026. Investigation is ongoing.

  Patient problems: Insufficient Information

  MAUDE report 50904471 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumothorax

  MAUDE report 50680618 ↗
• InjurySep 8, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pneumothorax

  MAUDE report 50680616 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT. LATER THAT DAY, THE PATIENT REPORTED SHORTNESS OF BREATH AND RIGHT-SIDE CHEST PAIN. A CHEST X-RAY CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2026. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE CHEST TUBE WAS REMOVED ON (B)(6) 2026, THE RESOLUTION DATE OF THE EVENT.

  Patient problems: Pneumothorax

  MAUDE report 24274093 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, PATIENT RECEIVED VALVE PLACEMENT. LATER THAT DAY, THE PATIENT REPORTED SHORTNESS OF BREATH AND RIGHT-SIDE CHEST PAIN. A CHEST X-RAY CONFIRMED A PNEUMOTHORAX. A CHEST TUBE WAS PLACED ON (B)(6) 2026. PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2026. THE CHEST TUBE WAS REMOVED ON (B)(6) 2026, THE RESOLUTION DATE OF THE EVENT.

  Patient problems: Pneumothorax

  MAUDE report 24274077 ↗
• InjuryNov 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT RECEIVED VALVE PLACEMENT AND EXPERIENCED A PNEUMOTHORAX. CHEST TUBE WAS PLACED ON (B)(6) 2025. INVESTIGATION IS ONGOING.

  Patient problems: Pneumothorax

  MAUDE report 23618489 ↗
• DeathNov 14, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT RECEIVED EBV VALVES ON (B)(6) 2025 AND EXPIRED IN THE EVENING. INVESTIGATION IS ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 23556517 ↗
• InjurySep 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025 THE PATIENT WHO RECEIVED A VALVE PLACEMENT ON (B)(6) 2025 EXPERIENCED A PNEUMOTHORAX. THE PNEUMOTHORAX WAS LARGE IN SIZE AND A CHEST TUBE WAS PLACED. ON (B)(6) 2025 VALVE WITH LOT NUMBER 507104-V7.0 WAS REMOVED. ON (B)(6) 2025 THE REMAINING TWO VALVES WERE REMOVED. THE CHEST TUBE WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025.

  Patient problems: Pneumothorax

  MAUDE report 23042737 ↗
• DeathJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED 4 VALVES ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH COPD EXACERBATIONS, PNEUMONIA AND RAPID DECLINE. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. PATIENT EXPIRED (B)(6) 2025.

  Patient problems: Pneumonia; Respiratory Failure

  MAUDE report 22515514 ↗
• DeathJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED 4 VALVES ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH COPD EXACERBATIONS, PNEUMONIA AND RAPID DECLINE. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2025. PATIENT EXPIRED (B)(6) 2025.

  Patient problems: Pneumonia; Pneumothorax; Respiratory Failure

  MAUDE report 22341987 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT HAD FIVE ZEPHYR VALVES IMPLANTED IN THE RIGHT LOWER LOBE ON (B)(6)2021. ON (B)(6)2023, HE WENT TO THE ER FOR CHEST PAIN AND SHORTNESS OF BREATH. HE WAS DIAGNOSED WITH ACUTE CHRONIC CONGESTIVE HEART FAILURE AND A RIGHT HYDROPNEUMOTHORAX AND PLEURAL EFFUSION. HE WAS ADMITTED TO THE HOSPITAL FOR RESPIRATORY FAILURE AND PLEURAL EFFUSION. TWO THORACENTESES WERE PERFORMED. THE PNEUMOTHORAX RESOLVED ON (B)(6) 2024. THE SUBJECT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Heart Failure/Congestive Heart Failure; Pleural Effusion; Pneumothorax; Respiratory Failure

  MAUDE report 20887891 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT BLVR ON (B)(6) 2024 WITH IMPLANTATION OF 5 VALVES IN THE RIGHT UPPER AND RIGHT MIDDLE LOBES. ON (B)(6) 2024, THE PATIENT EXPERIENCED A PNEUMOTHORAX, AND A CHEST TUBE WAS PLACED. ON (B)(6) 2024, THE CHEST TUBE WAS PLACED ON A WATER SEAL. ON (B)(6) 2024, THE PATIENT UNDERWENT A THORACOSCOPY AND PLEURODESIS WAS PERFORMED IN ADDITION TO A RIGHT MIDDLE LOBEBLEBECTOMY TO ADDRESS THE ALVEOLAR PLEURAL FISTULA. THE PATIENT WAS TRANSFERRED TO THE ICU. ON (B)(6) 2024, THE PATIENT TESTED POSITIVE FOR MRSA PNEUMONIA AND PUT ON IV ANTIBIOTICS. ON (B)(6) 2024, ONE VALVE WAS EXPLANTED. ON (B)(6) 2024, A SECOND CHEST TUBE WAS INSERTED. ON (B)(6)2024, THE REMAINING VALVES WERE EXPLANTED. ON (B)(6) 2024, A SINGLE VALVE WAS IMPLANTED TO ADDRESS THE ONGOING AIR LEAK. THE PATIENT WAS DISCHARGED TO LONG-TERM CARE ON (B)(6) 2024, WITH THE PNEUMOTHORAX ONGOING. THE PATIENT HAD CHEST TUBES REMOVED AND WAS DISCHARGED (B)(6) 2025.

  Patient problems: Fistula; Pneumothorax

  MAUDE report 20885054 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT BLVR ON (B)(6)/2024 WITH IMPLANTATION OF 5 VALVES IN THE RIGHT UPPER AND RIGHT MIDDLE LOBES. ON (B)(6)2024, THE PATIENT EXPERIENCED A PNEUMOTHORAX, AND A CHEST TUBE WAS PLACED. ON (B)(6)2024, THE CHEST TUBE WAS PLACED ON A WATER SEAL. ON (B)(6)2024, THE PATIENT UNDERWENT A THORACOSCOPY AND PLEURODESIS WAS PERFORMED IN ADDITION TO A RIGHT MIDDLE LOBE BLEBECTOMY TO ADDRESS THE ALVEOLAR PLEURAL FISTULA. THE PATIENT WAS TRANSFERRED TO THE ICU. ON (B)(6)2024, THE PATIENT TESTED POSITIVE FOR MRSA PNEUMONIA AND PUT ON IV ANTIBIOTICS. ON (B)(6)2024, ONE VALVE WAS EXPLANTED. ON (B)(6)2024, A SECOND CHEST TUBE WAS INSERTED. ON (B)(6)2024, THE REMAINING VALVES WERE EXPLANTED. ON (B)(6)2024, A SINGLE VALVE WAS IMPLANTED TO ADDRESS THE ONGOING AIR LEAK. THE PATIENT WAS DISCHARGED TO LONG-TERM CARE ON (B)(6)2024, WITH THE PNEUMOTHORAX ONGOING. THE PATIENT HAD CHEST TUBES REMOVED AND WAS DISCHARGED (B)(6)2025.

  Patient problems: Fistula; Pneumothorax

  MAUDE report 20883918 ↗
• InjuryDec 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT BLVR ON (B)(6) 2024 WITH IMPLANTATION OF 5 VALVES IN THE RIGHT UPPER AND RIGHT MIDDLE LOBES. ON (B)(6) 2024, THE PATIENT EXPERIENCED A PNEUMOTHORAX, AND A CHEST TUBE WAS PLACED. ON (B)(6) 2024, THE CHEST TUBE WAS PLACED ON A WATER SEAL. ON (B)(6) 2024, THE PATIENT UNDERWENT A THORACOSCOPY AND PLEURODESIS WAS PERFORMED IN ADDITION TO A RIGHT MIDDLE LOBEBLEBECTOMY TO ADDRESS THE ALVEOLAR PLEURAL FISTULA. THE PATIENT WAS TRANSFERRED TO THE ICU. ON (B)(6) 2024, THE PATIENT TESTED POSITIVE FOR MRSA PNEUMONIA AND PUT ON IV ANTIBIOTICS. ON (B)(6) 2024, ONE VALVE WAS EXPLANTED. ON (B)(6) 2024, A SECOND CHEST TUBE WAS INSERTED. ON (B)(6) 2024, THE REMAINING VALVES WERE EXPLANTED. ON (B)(6) 2024, A SINGLE VALVE WAS IMPLANTED TO ADDRESS THE ONGOING AIR LEAK. THE PATIENT WAS DISCHARGED TO LONG-TERM CARE ON (B)(6) 2024, WITH THE PNEUMOTHORAX ONGOING. THE PATIENT HAD CHEST TUBES REMOVED AND WAS DISCHARGED (B)(6) 2025.

  Patient problems: Fistula; Pneumothorax

  MAUDE report 20883240 ↗
• InjuryDec 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SUBJECT HAD THREE ZEPHYR VALVES IMPLANTED IN THE RIGHT UPPER LOBE ON (B)(6) 2024. ON (B)(6) 2024, HE EXPERIENCED A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2024 WITH THE CHEST TUBE IN PLACE. THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. A CHEST X-RAY SHOWED RECURRENT PNEUMOTHORAX. A NEW CHEST TUBE WAS PLACED. A CHEST X-RAY ON (B)(6) 2024 SHOWED A PLEURAL EFFUSION. PLEURAL ADHESION WAS IDENTIFIED ON (B)(6) 2024. PATIENT UNDERWENT VATS ON (B)(6) 2024. THE PNEUMOTHORAX RESOLVED ON (B)(6) 2024.

  Patient problems: Pleural Effusion; Pneumothorax

  MAUDE report 20860890 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ZEPHYR VALVES IMPLANTED ON (B)(6) 2024. THEY EXPERIENCED A PNEUMOTHORAX POST-PROCEDURE AND A CHEST TUBE WAS PLACED ON (B)(6) 2024. THE PATIENT CONTINUED TO HAVE AN AIR LEAK. THE VALVES WERE EXPLANTED AND THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Pneumothorax

  MAUDE report 20782880 ↗
• InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ZEPHYR VALVES IMPLANTED ON (B)(6) 2024. THEY EXPERIENCED A PNEUMOTHORAX POST-PROCEDURE AND A CHEST TUBE WAS PLACED ON (B)(6) 2024. THE PATIENT CONTINUED TO HAVE AN AIR LEAK. THE VALVES WERE EXPLANTED AND THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Pneumothorax

  MAUDE report 20778031 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD EIGHT ZEPHYR VALVES IMPLANTED IN THE LEFT LOWER LOBE ON (B)(6) 2024. THE PATIENT HAD A PNEUMOTHORAX ON (B)(6) 2024 AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT'S ATRIAL FIBRILLATION FLARED. THE PATIENT ELECTED TO START HOSPICE ON (B)(6) 2024. THE PATIENT DIED AT HOME ON (B)(6) 2024. THE DOCTOR STATED THAT THE CAUSE OF DEATH AND ATRIAL FIBRILLATION WERE NOT RELATED TO COPD OR THE BLVR PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 20592416 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD EIGHT ZEPHYR VALVES IMPLANTED IN THE LEFT LOWER LOBE ON (B)(6) 2024. THE PATIENT HAD A PNEUMOTHORAX ON (B)(6) 2024 AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX RESOLVED AND THE PATIENT'S ATRIAL FIBRILLATION FLARED. THE PATIENT ELECTED TO START HOSPICE ON (B)(6) 2024. THE PATIENT DIED AT HOME ON (B)(6) 2024. THE DOCTOR STATED THAT THE CAUSE OF DEATH AND ATRIAL FIBRILLATION WERE NOT RELATED TO COPD OR THE BLVR PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 20592374 ↗
• DeathAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS A 60-YEAR-OLD MALE WITH A 40 PACK YEAR SMOKING HISTORY (QUIT ON (B)(6) 2023) WITH PRIOR MEDICAL HISTORY OF SEVERE COPD, CHRONIC HYPOXIC RESPIRATORY FAILURE ON 4L NC BASELINE SINCE (B)(6) 2023. HE WAS INITIALLY SEEN IN CLINIC FOR BLVR EVALUATION (B)(6) 2023. AT THAT TIME, HE WAS COMPLAINING OF DYSPNEA WITH MINIMAL EXERTION, MMRC WAS 4 AT THAT TIME, HE WAS NOT ON STEROIDS AND HAD LESS THAN 2 COPD EXACERBATION IN THE PAST 2 YEARS. HE COMPLETED PULMONARY REHAB. HE DID NOT HAVE ANY PREVIOUS INTRATHORACIC SURGERIES. HE WAS ON OPTIMAL MEDICAL THERAPY FOR COPD WITH BREZTRI AND PRN ALBUTEROL. CT CHEST DONE SHOWED NO EVIDENCE OF PULMONARY NODULES. QCT REVIEW IDENTIFIED TWO POTENTIAL TARGETS FOR VALVE TREATMENT: RUL/RML PRIMARY TARGET AND LUL SECONDARY TARGET. PATIENT MET ALL OTHER CRITERIA AND WAS TREATED ON (B)(6) 2024 IN THE LUL AFTER CHART IS ASSESSMENT (LUL WAS CV NEGATIVE WHILE THE RIGHT SIDE HAD COLLATERAL VENTILATION. FIVE (5) VALVES WERE PLACED IN THE LUL. PATIENT DEVELOPED TENSION PNEUMOTHORAX POST-EXTUBATION AND A CHEST WAS PLACED WAS PLACED EMERGENTLY. CHEST XRAY IN THE MORNING ((B)(6) 2024) SHOWED NO IMPROVEMENT IN PNEUMOTHORAX AND PATIENT UNDERWENT REPEAT BRONCHO

  Patient problems: Cardiac Arrest; Pneumothorax; Respiratory Arrest

  MAUDE report 20057894 ↗
• InjuryJul 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(6) 2024, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. TREATMENT IS ONGOING. MORE INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 19659213 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(6) 2024, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. TREATMENT IS ONGOING. MORE INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 19463872 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(4)6 2024, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. TREATMENT IS ONGOING. MORE INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 19463755 ↗
• InjuryJun 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE ON (B)(6) 2024. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(6) 2024, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. TREATMENT IS ONGOING. MORE INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 19463753 ↗
• DeathApr 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A BRONCHOSCOPIC LUNG VOLUME REDUCTION (BLVR) PROCEDURE WITH SIX ZEPHYR VALVES PLACED IN THE LEFT UPPER LOBE. THE PATIENT HAD A PNEUMOTHORAX IN THE POST-ANESTHESIA CARE UNIT, AND A CHEST TUBE WAS INSERTED. VALVES WERE REMOVED ON (B)(6) 2024. THE PATIENT PASSED AWAY ON (B)(6) 2024. FOLLOW-UP INFORMATION WAS REQUESTED, BUT HAS NOT BEEN RECEIVED YET AS OF THE TIME OF THIS REPORT. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

  Patient problems: Pneumothorax

  MAUDE report 19182965 ↗

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