Zephyr Endobronchial Valve EBV-TS-5.5-LPRecalls & reported problems

Summary

The FDA's MAUDE database contains 205 adverse event reports that list this exact device (DI 00811907030423), received between Oct 14, 2019 and Nov 14, 2025 — classified as 24 deaths, 180 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 31, 2023Class IIOpen, Classified

   Endobronchial implant devices may have been labeled with a shortened expiration date but they can be used until the correct expiration date: 08 December 2024.

   Z-0235-2024 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 205 reports, in the reporter's own words as published by the FDA.

• 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 23556601 ↗
• MalfunctionAug 6, 2025Firing Problem

  VALVE DID NOT LOAD ONTO THE DEPLOYER PROPERLY. STUCK OUT OF DEPLOYER HALF DEPLOYED. UNABLE TO USE VALVE. DID THIS FOR 2 VALVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728371 ↗
• InjuryApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD THREE ZEPHYR VALVES IMPLANTED ON (B)(6) 2025. THE PATIENT HAD A PNEUMOTHORAX ON (B)(6) 2025 AND A CHEST TUBE WAS PLACED. ALL THREE VALVES WERE REMOVED ON (B)(6) 2025 DUE TO THE PNEUMOTHORAX IN THE IPSILATERAL LOBE AND DEVELOPMENT OF A LARGE BLEB THAT WAS NOT PRESENT PRIOR TO THE BLVR PROCEDURE. ON (B)(6) 2025, THE PATIENT'S CHEST TUBE WAS REMOVED AND THE PATIENT WAS DISCHARGED (SURGICAL OPTIONS ARE BEING EXPLORED FOR THE BLEB).

  Patient problems: Pneumothorax

  MAUDE report 21859640 ↗
• 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 21668650 ↗
• 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 THORACENTESIS 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 20886206 ↗
• InjuryDec 5, 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 20858932 ↗
• 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 20782899 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD THREE ZEPHYR VALVES IMPLANTED IN THE LEFT UPPER LOBE ON (B)(6) 2024. THE PATIENT HAD A PNEUMOTHORAX AND A CHEST TUBE WAS INSERTED ON (B)(6) 2024. THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT REPORTED A "SUDDEN POP" IN THEIR CHEST AND DYSPNEA. THEY WERE ADMITTED WITH A PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. THE PNEUMOTHORAX DID NOT RESOLVE SO A SECOND CHEST TUBE WAS INSERTED. ON (B)(6) 2024, ALL VALVES WERE EXPLANTED. TWO OF THE VALVES HAD THE ONE-WAY PORTION INVERTED. A CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE SECOND CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Pneumothorax

  MAUDE report 20775843 ↗
• 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 20592495 ↗
• 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 19659084 ↗
• InjuryJul 1, 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. ALL VALVES WERE REMOVED ON (B)(6) 2024. THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE EVENT WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Pneumothorax

  MAUDE report 19651023 ↗
• InjuryJun 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Pneumothorax

  MAUDE report 19531316 ↗
• DeathApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS A FOLLOW UP REPORT RELATED TO THE SAME MDR EVENT ALREADY INCLUDED IN THE FOLLOWING REPORT NUMBER SUBMITTED TO THE FDA: 3007797756-2023-00220. THIS REPORT COVERS THE ADDITIONAL DEVICE USED IN THIS CASE. PATIENT SELECTED FOR VALVE THERAPY AFTER PFT, SYMPTOMS, PERFUSION SCAN AND INTRA OP BALLOON OCCLUSION DETERMINED HER TO MEET ALL CRITERIA. PROCEDURE PERFORMED ON (B)(6) 2023 WITH 3 VALVES IN RUL. AFTER PROCEDURE- NO PNEUMOTHORAX AND COMPLETE ATELECTASIS OF THE RUL JUST AS PLANNED. PATIENT REFUSED TO EXERCISE, LET NURSES MOVE HER AND PREFERRED TO BE BED BOUND IN HOSPITAL. THEREFORE - SHE BECAME NASAL CANNULA DEPENDENT FROM BASILAR ATELECTASIS AND MUCUS IMPACTIONS. PATIENT DID NOT WANT TO PARTICIPATE IN AIRWAY CLEARANCE. FINALLY, SHE STARTED TELLING TEAM THAT HER DAUGHTER FORCED HER TO HAVE THE VALVES AND THAT SHE DID NOT WANT THE VALVES. THE PHYSICIAN NOTES THAT THIS WAS NOT HIS EXPERIENCE IN PRE - PROCEDURE INTERVIEWS AND DETAILED PROLONGED WORK UP. THE PATIENT CLAIMED THAT SHE WAS MORE SHORT OF BREATH AFTER PROCEDURE AND SHE WANTED VALVES OUT. THIS WAS DURING THE TIME SHE WAS REFUSING ALL PT/OT AND OTHER THERAPIES. PER THE PATIENT'S WISHES THE VALVES WERE REMOVED (B)(6) 2023

  Patient problems: Insufficient Information

  MAUDE report 19174206 ↗
• DeathMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS A 72-YEAR OLD FEMALE WITH A HISTORY OF COPD, CHRONIC HYPOXIC RESPIRATORY FAILURE, ATRIAL FIBRILLATION, CORONARY ARTERY DISEASE (CAD), HYPERTENSION (HTN), DIABETES MELLITUS (DM), GERD, HYPOTHYROIDISM, ANXIETY/DEPRESSION, AND OBESITY (BMI 31). SHE WAS EVALUATED FOR BLVR AND UNDERWENT A VALVE PLACEMENT PROCEDURE ON (B)(6) /2024. THE PROCEDURE WAS COMPLETED WITH PLACEMENT OF TWO ZEPHYR VALVES IN THE LEFT UPPER LOBE (LB1/LB2/LB3 - 5.5-LP; LB4/LB5 - 4.0-LP). THE PATIENT WAS KEPT IN ICU OVERNIGHT THEN TRANSFERRED TO STEPDOWN FLOOR. NO ISSUES DURING STAY. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2024. SHE WAS DOING GREAT AT HOME AND SHORTNESS OF BREATH HAD SIGNIFICANTLY IMPROVED. ON (B)(6) 2024 SHE WENT TO THE RESTROOM AND HAD A "COUGHING FIT" AND THEN STARTED TO SWELL UP. SHE WAS TAKEN TO LOCAL ER WHERE CHEST TUBES WERE PLACED FOR A PNEUMOTHORAX AND SUBSEQUENT SEVERE SUBCUTANEOUS AIR. EVENTUALLY SHE WAS INTUBATED AND THEN TRANSFERRED TO THE TREATING HOSPITAL. SHE WAS EXTUBATED ON (B)(6) 2024. THE SMALL-BORE CHEST TUBE #1 WAS REMOVED ON (B)(6) 2024. LARGE BORE CHEST TUBE #2 WAS REMOVED ON (B)(6) 2024 AFTER BEING ON WATER SEAL FOR DAYS. SHE HAD SOME ANEMIA BUT NO OBVIOUS BLEEDI

  Patient problems: Pneumothorax

  MAUDE report 18914770 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A BRONCHOSCOPIC LUNG VOLUME REDUCTION REVISION PROCEDURE WITH THREE ZEPHYR VALVES PLACED IN THE LEFT UPPER LOBE ON (B)(6) 2021. THE PATIENT HAD A PNEUMOTHORAX WHICH WAS PREVIOUSLY REPORTED IN MFR. REPORT #S 3007797756-2022-00124, 3007797756-2022-00125, AND 3007797756-2022-00126 IN (B)(6) 2022. THIS REPORT IS BEING SUBMITTED TO DOCUMENT SUBSEQUENT ADVERSE EVENTS THAT WERE NOT INCLUDED IN THE PRIOR REPORTS. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR RESPIRATORY DISTRESS, REQUIRING DRAINAGE OF A LEFT LUNG HEMOTHORAX. THE HEMOTHORAX WAS RESOLVED ON (B)(6)2021. THE PATIENT EXPERIENCED RESPIRATORY FAILURE ON (B)(6) 2022 AND WAS READMITTED TO A HOSPITAL AND DIAGNOSED WITH ONGOING RESPIRATORY DISTRESS REQUIRING OXYGEN THERAPY. HE WAS STARTED ON IV STEROIDS. PATIENT WAS TRANSFERRED FOR ADMISSION TO THE TREATING HOSPITAL ON (B)(6) 2022 FOR CONSIDERATION OF EBV REMOVAL, AND REMOVAL OF ALL VALVES WAS DONE ON (B)(6) 2022. AFTER THE PROCEDURE, PATIENT REPORTED IMPROVEMENT IN SHORTNESS OF BREATH. STEROIDS WERE WEANED TO PREDNISONE (40MG DAILY). ON (B)(6) 2022, THE RESPIRATORY FAILURE WAS RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON JAN. 9, 2022 AN

  Patient problems: Hemothorax; Respiratory Failure

  MAUDE report 18743607 ↗
• InjuryFeb 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A BRONCHOSCOPIC LUNG VOLUME REDUCTION REVISION PROCEDURE WITH THREE ZEPHYR VALVES PLACED IN THE LEFT UPPER LOBE ON (B)(6) 2021. THE PATIENT HAD A PNEUMOTHORAX WHICH WAS PREVIOUSLY REPORTED IN MFR. REPORT #S 3007797756-2022-00124, 3007797756-2022-00125, AND 3007797756-2022-00126 IN (B)(6) 2022. THIS REPORT IS BEING SUBMITTED TO DOCUMENT SUBSEQUENT ADVERSE EVENTS THAT WERE NOT INCLUDED IN THE PRIOR REPORTS. ON (B)(6) 2021, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR RESPIRATORY DISTRESS, REQUIRING DRAINAGE OF A LEFT LUNG HEMOTHORAX. THE HEMOTHORAX WAS RESOLVED ON (B)(6) 2021. THE PATIENT EXPERIENCED RESPIRATORY FAILURE ON (B)(6) 2022 AND WAS READMITTED TO A HOSPITAL AND DIAGNOSED WITH ONGOING RESPIRATORY DISTRESS REQUIRING OXYGEN THERAPY. HE WAS STARTED ON IV STEROIDS. PATIENT WAS TRANSFERRED FOR ADMISSION TO THE TREATING HOSPITAL ON (B)(6) 2022 FOR CONSIDERATION OF EBV REMOVAL, AND REMOVAL OF ALL VALVES WAS DONE ON (B)(6) 2022. AFTER THE PROCEDURE, PATIENT REPORTED IMPROVEMENT IN SHORTNESS OF BREATH. STEROIDS WERE WEANED TO PREDNISONE (40MG DAILY). ON (B)(6) 2022, THE RESPIRATORY FAILURE WAS RESOLVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022 AN

  Patient problems: Hemothorax; Respiratory Failure

  MAUDE report 18743543 ↗
• InjuryJan 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE ADDITIONAL MANUFACTURE NARRATIVE SECTION FOR MORE DETAILS. THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE WITH THREE VALVES PLACED ON (B)(6), 2023. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON THE SAME DAY. ONE VALVE WAS REMOVED ON (B)(6), 2023. THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE ON (B)(6) 2023, TO RE-IMPLANT A VALVE AT RB3 THAT HAD BEEN PREVIOUSLY REMOVED DUE TO AN EARLIER PNEUMOTHORAX EVENT. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON OCTOBER 31, 2023, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. ALL VALVES WERE REMOVED ON NOVEMBER 4, 2023. THE PATIENT PRESENTED WITH ANOTHER PNEUMOTHORAX ON NOVEMBER 5, 2023. A CHEST TUBE WAS PLACED ON NOVEMBER 5, 2023, TO HELP WITH AIR-LEAK. THE CHEST TUBE WAS REMOVED ON (B)(6), 2023. THE PATIENT WAS DISCHARGED ON (B)(6) 2023, WITH HEIMLICH VALVE, AND WILL BE FOLLOWED UP AS OUTPATIENT.

  Patient problems: Pneumothorax

  MAUDE report 18592260 ↗
• InjuryJan 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE WITH FIVE VALVES PLACED ON (B)(6) 2023. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(6) 2023, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. THE CHEST TUBE AND TWO VALVES WERE REMOVED ON (B)(6) 2023. THE EVENT WAS RESOLVED ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 18523012 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A BRONCHOSCOPIC LUNG VOLUME REDUCTION REVISION PROCEDURE WITH ONE ZEPHYR VALVE PLACED ON (B)(6) 2023. ON DEC. 12, 2023, WHEN THE PATIENT WAS AT HOME, THE PATIENT HAD TROUBLE BREATHING AND RETURNED TO THE HOSPITAL. AN X-RAY CONFIRMED A PNEUMOTHORAX OCCURRED, AND A CHEST TUBE WAS PLACED ON THE SAME DAY. AFTER IMPROVEMENT THE CHEST TUBE WAS REMOVED ON (B)(6) 2023, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 18493865 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE WITH FOUR ZEPHYR VALVES PLACED ON (B)(6), 2023. THE IMMEDIATE POST-PROCEDURE CHEST X-RAY DID NOT REVEAL A PNEUMOTHORAX. FOLLOWING TRANSFER TO THE POST ANESTHESIA CARE UNIT (PACU) FOR OBSERVATION, THE PATIENT BECAME TACHYPNEIC AND HAD MILD DISTRESS. A FOLLOW-UP CHEST X-RAY ON (B)(6), 2023 SHOWED A SMALL, LEFT-SIDED PNEUMOTHORAX. A 14 FR. CHEST TUBE WAS INSERTED WITH IMMEDIATE IMPROVEMENT IN RESPIRATORY STATUS. AFTER RESOLUTION ON (B)(6), 2023, THE CHEST TUBE WAS REMOVED. THE PATIENT WAS DISCHARGED ON (B)(6), 2023.

  Patient problems: Pneumothorax

  MAUDE report 18378626 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SEE ADDITIONAL MANUFACTURE NARRATIVE SECTION FOR MORE DETAILS. THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE ON (B)(6) 2023. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(6) 2023, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. THE CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE PATIENT PRESENTED WITH ANOTHER PNEUMOTHORAX ON (B)(6) 2023, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. THE CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE PATIENT PRESENTED WITH ANOTHER PNEUMOTHORAX ON (B)(6) 2023, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. ALL VALVES WERE REMOVED ON (B)(6) 2023. THE CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE EVENT WAS RESOLVED ON OCTOBER 27, 2023, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 18360115 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN ENDOBRONCHIAL VALVE PROCEDURE WITH FIVE VALVES PLACED ON (B)(6) 2023. THE PATIENT PRESENTED WITH A PNEUMOTHORAX ON (B)(6) 2023, AND A CHEST TUBE WAS PLACED ON THE SAME DAY TO HELP WITH AIR-LEAK. THE CHEST TUBE WAS REMOVED ON (B)(6) 2023. NO VALVES WERE REMOVED. THE EVENT WAS RESOLVED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 18359047 ↗
• DeathNov 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ZEPHYR VALVES IMPLANTED ON (B)(6) 2023. THE PATIENT EXPERIENCED A PNEUMOTHORAX POST-PROCEDURE. THE PATIENT WAS DISCHARGED AND THEN READMITTED. THE PATIENT HAS SINCE PASSED AWAY. FURTHER INFORMATION WILL BE REPORTED ONCE AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 18232531 ↗
• InjuryNov 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A PNEUMOTHORAX. TREATMENT IS ONGOING. MORE INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 18223040 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD FOUR ZEPHYR VALVES IMPLANTED IN THE LEFT UPPER LOBE ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT WAS DISCHARGED. AT HOME, THE PATIENT HAD CHEST PAIN AND SHORTNESS OF BREATH. HE WAS ADMITTED OT THE HOSPITAL WITH A LEFT, LARGE, TENSION PNEUMOTHORAX AND A CHEST TUBE WAS PLACED. HE TRANSFERRED HOSPITALS ON (B)(6) 2023. THE CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 18136630 ↗