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

Summary

The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 00811907030324), received between Nov 21, 2018 and Sep 25, 2026 — classified as 31 deaths, 250 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 282 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 50904470 ↗
• 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 24274080 ↗
• 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 21859597 ↗
• DeathApr 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A BLVR PROCEDURE WAS COMPLETED INCLUDING IMPLANTATION OF FOUR VALVES (ONE VALVE IN THE RIGHT MIDDLE LOBE (RML) AND THREE IN THE RIGHT UPPER LOBE (RUL) ON (B)(6) 2025. PER THE PHYSICIAN, THE PROCEDURE DURATION LASTED FOR ABOUT ONE HOUR. ON (B)(6) 2025, ALL FOUR VALVES WERE EXPLANTED DUE TO A DECLINE IN THE PATIENT'S RESPIRATORY STATUS FOLLOWING THE PROCEDURE WHILE IN THE ICU. THE VALVES REMAINED IMPLANTED FOR A TOTAL OF 3 DAYS. ON (B)(6) 2025, IMMEDIATELY FOLLOWING THE BRONCHOSCOPY, THE PATIENT EXPERIENCED A FAILED EXTUBATION DUE TO CO[?] RETENTION AND HYPERSOMNOLENCE, REQUIRING RE-INTUBATION AND TRANSFER TO THE ICU. DESPITE VARIOUS VENTILATOR ADJUSTMENTS, THE PATIENT DEMONSTRATED VERY POOR AIR MOVEMENT. THE VALVES WERE REMOVED AFTER THREE DAYS; HOWEVER, THE PATIENT'S CONDITION DID NOT IMPROVE. THE PATIENT CONTINUED TO DETERIORATE AND SUBSEQUENTLY PASSED AWAY ON (B)(6) 2025. PER THE MEDICAL CHART, THE FOLLOWING STATEMENT WAS DOCUMENTED: "DUE TO PERSISTENCE OF VENTILATOR DEPENDENCE AND INABILITY TO WEAN PATIENT SUCCESSFULLY FROM PARALYSIS AND DEEP SEDATION, COUNSELED FAMILY THAT NEXT TREATMENT OPTION WAS TO UNDERGO TRACHEOSTOMY PLACEMENT VERSUS PURSUE COMFORT FOCUSED CARE. IN SPEAKIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21857674 ↗
• 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 HYPERCAPNIA. A CHEST X-RAY SHOWED THERE WAS A LARGE RIGHT PNEUMOTHORAX WHERE A CHEST TUBE WAS INSERTED AND THE PATIENT'S TACHYCARDIA, TACHYPNEA, AND HYPERCAPNIA 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 21668654 ↗
• InjuryDec 10, 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 EMERGENCY ROOM 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 20888554 ↗
• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD (B)(4) 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. (B)(4) 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 20773503 ↗
• InjuryAug 21, 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) 2023. THE PATIENT WAS DISCHARGED ON (B)(6)2024. THAT EVENING, THE PATIENT RETURNED TO THE HOSPITAL WITH A PNEUMOTHORAX, WAS READMITTED, AND A CHEST TUBE WAS PLACED. ON (B)(6) 2024, THE PATIENT HAD WORSENING RESPIRATORY FAILURE, WAS TRANSFERRED TO THE ICU, AND WAS ELECTIVELY INTUBATED. ONE VALVE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS EXTUBATED ON (B)(6) 2024. THE PNEUMOTHORAX RESOLVED AND THE CHEST TUBE WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

  Patient problems: Pneumothorax

  MAUDE report 20012375 ↗
• 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 19651180 ↗
• 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 19174219 ↗
• InjuryApr 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD ZEPHYR VALVES IMPLANTED IN THE RIGHT UPPER AND MIDDLE LOBES ON (B)(6) 2024. PATIENT DEVELOPED RECURRENT PNEUMOTHORACES AND A CHEST TUBE WAS PLACED. THE PATIENT WAS DISCHARGED WITH THE CHEST TUBE IN PLACE. THE PATIENT HAD PERSISTENT AIR LEAK WITH A LACK OF RESOLUTION OF THE PNEUMOTHORAX. THE PATIENT WAS BROUGHT IN AND THE VALVES WERE REMOVED FROM THE RIGHT MIDDLE LOBE. THE CHEST TUBE WAS REMOVED AND REPLACED. THE PATIENT DEVELOPED PLEURAL EFFUSION THAT WAS DRAINED WITH ANOTHER CHEST TUBE. THE PNEUMOTHORAX RESOLVED ON (B)(6) 2024. THE CHEST TUBE WAS REMOVED ON (B)(6) 2024.

  Patient problems: Pleural Effusion; Pneumothorax

  MAUDE report 19029415 ↗
• DeathMar 1, 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: 3007797756-2023-00228. THIS REPORT COVERS THE ADDITIONAL DEVICE USED IN THIS CASE. THIS 66-YR OLD MALE PATIENT WITH CARDIAC HISTORY WAS SUFFERING FROM SEVERE COPD ON 4-5L 02 AT BASELINE. HE UNDERWENT BLVR TO THE LEFT UPPER LOBE WITH 3 ZEPHYR® VALVES (5.5 REGULAR TO OCCLUDE LUL APICAL/POSTERIOR/ANTERIOR; 4 REGULAR TO OCCLUDE SUPERIOR LINGULA; AND 4 REGULAR TO OCCLUDE INFERIOR LINGULA). POST-OP CXR SHOWED A TINY LEFT PNEUMOTHORAX WHICH INCREASED ON FOLLOW-UP FILMS; SO A 14 FR CHEST TUBE WAS PLACED ON POST-OP DAY 0. ON POST-OP DAY 4, HE HAD INCREASING SUBCUTANEOUS AIR WITH ENLARGING PNEUMOTHORAX. SO A 2ND CHEST TUBE WAS PLACED. CHEST TUBE #1 WAS REMOVED ON POST-OP DAY 6. PATIENT HAD PERSISTENT AIR LEAK. THUS THE MEDICAL TEAM DISCUSSED VALVE REMOVAL, BUT THE PATIENT WANTED TO GIVE IT LONGER TO SEE IF LEAK WOULD RESOLVE AS HE CLINICALLY FELT BETTER WITH VALVES. THE AIR LEAK SLOWLY IMPROVED, AND ON POST-OP DAY 13 HE UNDERWENT CHEMICAL PLEURODESIS. HE TOLERATED A PROLONGED CLAMP TRIAL AND CHEST TUBE WAS REMOVED ON POST-OP DAY 20. HOWEVER, HE DEVELOPED WORSENING HY

  Patient problems: Pneumothorax

  MAUDE report 18822811 ↗
• InjuryFeb 23, 2024Adverse 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 18768756 ↗
• 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 18744068 ↗
• InjuryDec 21, 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. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT EXPERIENCED CHEST PAIN AND EXPERIENCED A LARGE, LEFT-SIDED PNEUMOTHORAX. A CHEST TUBE WAS PLACED THE SAME DAY. THE PNEUMOTHORAX WORSE DENED AND THE LINGULAR VALVE WAS REMOVED 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 18378664 ↗
• 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 18359059 ↗
• 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 18232527 ↗
• 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 18136629 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH A PNEUMOTHORAX. THE PATIENT CURRENTLY HAS A CHEST TUBE IN AND TREATMENT IS ONGOING. MORE INFORMATION WILL BE PROVIDED WHEN AVAILABLE.

  Patient problems: Pneumothorax

  MAUDE report 18136232 ↗
• DeathNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS A 77 YEAR-OLD MALE DIAGNOSED WITH SEVERE COPD/EMPHYSEMA ON CHRONIC HOME OXYGEN AND A NUMBER OF COMORBIDITIES INCLUDING POLIO WITHOUT RESIDUAL WEAKNESS, LUMBAR SPINAL STENOSIS, HYPERTENSION, HYPERLIPIDEMIA, ANXIETY, AND BPH. THE PATIENT WAS SUITABLE FOR BRONCHOSCOPIC LUNG VOLUME REDUCTION WITH VALVES AND UNDERWENT THE PROCEDURE ON (B)(6) 2023. THREE ZEPHYR ENDOBRONCHIAL VALVES PLACED TO THE LEFT UPPER LOBE . DURING THE PROCEDURE, SECRETIONS WERE NOTED WITHIN THE AIRWAY WHICH WERE COLLECTED AS BRONCHIAL WASHING AND SENT FOR MICROBIOLOGIC ANALYSIS. POST PROCEDURE, THE PATIENT DEVELOPED A LARGE PNEUMOTHORAX IDENTIFIED WITHIN 1 HOUR OF PROCEDURE IN THE PACU WITH IMMEDIATE INSERTION OF 14 FRENCH PIGTAIL CATHETER UPON PNEUMOTHORAX IDENTIFICATION. HE HAD A SEVERE PERSISTENT AIR LEAK. HE WAS THEN HOSPITALIZED TO THE INTERNAL MEDICINE SERVICE HOWEVER DUE TO INCREASING OXYGEN REQUIREMENTS (UP TO 15 L NON-REBREATHER) AND SEVERE DYSPNEA/TACHYPNEA, HE WAS TRANSFERRED TO THE ICU ON (B)(6) 2023. HE WAS STARTED ON AS NEEDED OPIOIDS AS WELL AS PRECEDEX INFUSION. HIS PNEUMOTHORAX SLIGHTLY WORSENED DESPITE THE SINGLE 14 FRENCH PIGTAIL CATHETER AND THUS A 2ND 14 FRENCH PIGTAIL CATHETER

  Patient problems: Pneumothorax

  MAUDE report 18094333 ↗
• InjuryNov 7, 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 (THREE 4.0 EBVS, ONE 5.5 EBV) PLACED IN THE LEFT UPPER LOBE (LUL) ON (B)(6) 2023. THE PHYSICIAN DID A BRONCHOSCOPY ON (B)(6) 2023 (STANDARD PRACTICE PER THE PHYSICIAN), AND THE VALVES LOOKED GOOD. THE PATIENT WAS DISCHARGED ON (B)(6) 2023 AND RETURNED WITHIN 24 HOURS WITH A TENSION PNEUMOTHORAX. A CHEST TUBE WAS INSERTED AND THE PATIENT WAS INTUBATED ON (B)(6) 2023. TWO VALVES WERE REMOVED ON (B)(6) 2023; (5.5 EBV FROM THE LINGULA AND 4.0 EBV FROM ANTERIOR). ON (B)(6) 2023, THE REMAINING TWO 4.0 EBV VALVES IN THE APICAL AND POSTERIOR WERE REMOVED. ON (B)(6) 2023, AFTER RESOLUTION THE CHEST TUBE WAS REMOVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 18087267 ↗
• InjuryOct 17, 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 THREE ZEPHYR VALVES PLACED IN THE LEFT UPPER LOBE (LUL) ON (B)(6) 2023. THE PATIENT HAD A LEFT-SIDED PNEUMOTHORAX SHORTLY AFTER THE PROCEDURE. PATIENT HAD CONTINUOUS HIGH-FLOW AIR LEAK DESPITE TWO CHEST TUBES INSERTED ON (B)(6) 2023. ON (B)(6) 2023, ONE 5.5 EBV WAS REMOVED FROM THE LUL ANTERIOR SEGMENT. THE PATIENT HAD A CT SCAN SHOWING ATELECTASIS WAS NO LONGER PRESENT. ON (B)(6) 2023, THE PATIENT HAD HEMOPTYSIS. ON (B)(6) 2023, THE REMAINING TWO VALVES (I.E., ONE 5.5 EBV, ONE 5.5-LP EBV) WERE REMOVED. ON (B)(6) 2023, THE CHEST TUBES WERE REMOVED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023.

  Patient problems: Pneumothorax

  MAUDE report 17953791 ↗
• DeathOct 2, 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 THREE ZEPHYR VALVES PLACED IN THE LEFT UPPER LOBE ON (B)(6) 2023. A PNEUMOTHORAX WAS NOTED ON (B)(6) 2023, AND A 14 FR CHEST TUBE WAS PLACED AND ABLE TO DE-ESCALATE TO WATER SEAL. ON (B)(6) 2023, THE PNEUMOTHORAX BECAME WORSE WITH A MUCH BIGGER LEAK AND WAS PLACED ON SUCTION. THE PATIENT HAD INTERMITTENT EPISODES OF SEVERE ANXIETY AND DYSPNEA. ON (B)(6) 2023, A 24 FR PIGTAIL CHEST TUBE WAS PLACED. THE PATIENT WENT INTO HYPERCAPNIC RESPIRATORY FAILURE AND WAS INTUBATED ON (B)(6) 2023 IN THE EARLY MORNING. ON (B)(6) 2023, ALL VALVES WERE REMOVED. THE PATIENT WAS EXTUBATED ON (B)(6) 2023. ON (B)(6) 2023, THE PATIENT HAD SUPRAVENTRICULAR TACHYCARDIA (SVT) AND RESPIRATORY DISTRESS AND WAS REINTUBATED. THERE WAS A GOALS OF CARE (GOC) DISCUSSION ON (B)(6) 2023, AND THE PATIENT AND FAMILY MADE IT CLEAR THAT HE DID NOT WANT TO BE ON A VENTILATOR. THE PATIENT WAS TERMINALLY EXTUBATED AND PASSED PEACEFULLY ON (B)(6) 2023. NO AUTOPSY WAS PERFORMED.

  Patient problems: Pneumothorax

  MAUDE report 17853875 ↗
• InjurySep 20, 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 FIVE ZEPHYR VALVES PLACED IN THE RIGHT LOWER LOBE ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT DEVELOPED ACUTE DYSPNEA. PATIENT WENT TO THE HOSPITAL AND HAD A RECURRENT SPONTANEOUS, RIGHT-SIDED PNEUMOTHORAX AND A PIGTAIL CHEST TUBE WAS PLACED ON (B)(6) 2023. ON (B)(6) 2023, ALL FIVE VALVES WERE REMOVED. MUCUS, PLUGGING THE AIRWAY, WAS FOUND IN THE LEFT MAINSTEM BRONCHUS, AND WHITE EXUDATE WAS FOUND IN THE RIGHT LOWER LOBE. AN AREA OF FRIABLE MUCOSA WAS FOUND IN THE RIGHT LOWER LOBE. THERAPEUTIC SUCTIONING WAS PERFORMED IN THE LEFT MAINSTEM BRONCHUS AND IN THE RIGHT LOWER LOBE. MUCUS PLUGS WERE REMOVED FROM THE AIRWAY. THE SUCTIONED MATERIAL WAS SENT FOR ANALYSIS AND THE RESPIRATORY CULTURE TESTED POSITIVE FOR KLEBSIELLA AEROGENES. CHEST X-RAY DONE ON (B)(6) 2023 SHOWED IMPROVED BASILAR PNEUMOTHORAX, APICAL RIGHT-SIDED CHEST TUBE IS STABLE. THERE WAS A PERSISTENT SMALL RIGHT APICAL PNEUMOTHORAX WITH AN AIR GAP OF 1.9 CM, PREVIOUSLY MEASURED 1.5 CM. ON (B)(6) 2023, A SMALL AIR LEAK WAS STILL EVIDENT. CHEST X-RAY DONE ON (B)(6) 2023 SHOWED THERE WAS NO PNEUMOTHORAX. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(

  Patient problems: Pneumothorax

  MAUDE report 17785126 ↗
• InjurySep 13, 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) 2020. THE PATIENT PRESENTED AT HIS LOCAL HOSPITAL ON (B)(6) 2023 WITH ACUTE ONSET SHARP LEFT-SIDED CHEST PAIN. THE PATIENT WAS TRANSFERRED HOSPITALS AND DIAGNOSED AS HAVING A LEFT-SIDED PNEUMOTHORAX AND A CHEST TUBE WAS PLACED ON (B)(6) 2023. A RIGHT-SIDED CHEST TUBE WAS PLACED ON (B)(6) 2023. THE RIGHT-SIDED CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE LEFT-SIDED CHEST TUBE WAS REMOVED ON (B)(6) 2023. THE PATIENT WAS DISCHARGED ON (B)(6) 2023. THE PI DEEMED THIS EVENT RELATED TO THE DEVICE AS "PNEUMOTHORAX HAPPENED DUE TO VALVES PLACED IN IPSILATERAL LOBE CAUSING PNEUMOTHORAX BY MECHANICAL STRETCH ON THE NON-TREATED LOBE."

  Patient problems: Pneumothorax

  MAUDE report 17741532 ↗

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