Spiration Valve System SVS-V7-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00896506002279), received between Oct 17, 2019 and Apr 8, 2026 — classified as 3 deaths, 80 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

1 other recall cover devices cleared under the same FDA submission (P180007); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT THE PATIENT DEVELOPED PNEUMONIA IN THE VALVE-TREATED LOBE REQUIRING HOSPITALIZATION, IV ANTIBIOTICS, AND VALVE REMOVAL.

  Patient problems: Pneumonia

  MAUDE report 24816935 ↗
• InjuryApr 8, 2026Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT THE PATIENT DEVELOPED PNEUMONIA IN THE VALVE-TREATED LOBE REQUIRING HOSPITALIZATION, IV ANTIBIOTICS, AND VALVE REMOVAL.

  Patient problems: Pneumonia

  MAUDE report 24816934 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Loss of consciousness; Pneumothorax

  MAUDE report 24475267 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE AND 6 SPIRATION VALVES WERE PLACED IN THE LEFT UPPER LUNG. THE PATIENT HAD ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) APPROXIMATELY 8 DAYS AFTER VALVE PLACEMENT. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL AND WAS GIVEN INTRAVENOUS (IV) MEDICATION. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INJURY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE. THIS REPORT IS 4 OF 6 VALVES.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 24448622 ↗
• InjuryFeb 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE AND 6 SPIRATION VALVES WERE PLACED IN THE LEFT UPPER LUNG. THE PATIENT HAD ACUTE EXACERBATION OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) APPROXIMATELY 8 DAYS AFTER VALVE PLACEMENT. THE PATIENT WAS THEN ADMITTED TO THE HOSPITAL AND WAS GIVEN INTRAVENOUS (IV) MEDICATION. THE PATIENT WAS DISCHARGED WITHOUT FURTHER INJURY. THERE WERE NO FURTHER REPORTS OF PATIENT HARM. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE. THIS REPORT IS 1 OF 6 VALVES.

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD)

  MAUDE report 24448535 ↗
• MalfunctionDec 19, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE VALVE WAS NOT ABLE TO BE REMOVED DUE TO GRANULATION TISSUE. EVERY ATTEMPT WAS MADE TO REMOVE THE ORIGINAL VALVE BUT IT WAS UNSUCCESSFUL. A NEW VALVE WAS PLACED OVER IT TO OCCLUDE THE AIRWAY. ADDITIONALLY, THE CUSTOMER REPORTS THAT THE INITIAL VALVE WAS NOT PLACE IN THE CORRECT POSITION AND BY THE TIME THE DOCTOR WANTED TO REVISE IT, IT IS THEN THEY HAD TROUBLE REMOVING IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854675 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION SUBMITTED BY THE CUSTOMER.

  Patient problems: Pneumothorax

  MAUDE report 22668653 ↗
• InjuryJul 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER

  Patient problems: Pneumothorax

  MAUDE report 22668651 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST-MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM, (SVS), FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. THE SUBJECT (B)(6), ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED SHORTNESS OF BREATH, ATTRIBUTED TO VALVE DISPLACEMENT/MIGRATION AT TARGET LOCATIONS RB6 (LOT #WS388855) AND RB7 (LOT #WS383672). THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED AND TREATED WITH AZITHROMYCIN AND PREDNISONE BUT WAS NOT HOSPITALIZED. A VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE MIGRATION AND OPTIMIZE TREATMENT RESPONSE. THE PATIENT CONTINUED TO EXPERIENCE SHORTNESS OF BREATH, REQUIRING 5L NASAL CANNULA (NC) OXYGEN TO MAINTAIN STABILITY. ON (B)(6) 2025, THE SUBJECT DEVELOPED PNEUMONIA, LEADING TO HOSPITAL ADMISSION THE SAME DAY. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH SOLU-MEDROL, FOLLOWE

  Patient problems: Dyspnea; Loss of consciousness; Pneumonia; Respiratory Failure; Respiratory Insufficiency; Sepsis

  MAUDE report 22470993 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST-MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM, (SVS), FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. THE SUBJECT (B)(6), ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED SHORTNESS OF BREATH, ATTRIBUTED TO VALVE DISPLACEMENT/MIGRATION AT TARGET LOCATIONS RB6 (LOT #WS388855) AND RB7 (LOT #WS383672). THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED AND TREATED WITH AZITHROMYCIN AND PREDNISONE BUT WAS NOT HOSPITALIZED. A VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE MIGRATION AND OPTIMIZE TREATMENT RESPONSE. THE PATIENT CONTINUED TO EXPERIENCE SHORTNESS OF BREATH, REQUIRING 5L NASAL CANNULA (NC) OXYGEN TO MAINTAIN STABILITY. ON (B)(6) 2025, THE SUBJECT DEVELOPED PNEUMONIA, LEADING TO HOSPITAL ADMISSION THE SAME DAY. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH SOLU-MEDROL, FOLLOWE

  Patient problems: Dyspnea; Loss of consciousness; Pneumonia; Respiratory Failure; Respiratory Insufficiency; Sepsis

  MAUDE report 22470873 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST-MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM, (SVS), FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. THE SUBJECT (B)(6), ENROLLED IN THE STRIVE STUDY, UNDERWENT THERAPEUTIC MULTIPLE SPIRATION VALVE PLACEMENTS IN THE RIGHT LOWER LOBE UNDER GENERAL ANESTHESIA ON (B)(6) 2024. ON (B)(6) 2025, THE PATIENT REPORTED SHORTNESS OF BREATH, ATTRIBUTED TO VALVE DISPLACEMENT/MIGRATION AT TARGET LOCATIONS RB6 (LOT #WS388855) AND RB7 (LOT #WS383672). THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS PRESCRIBED AND TREATED WITH AZITHROMYCIN AND PREDNISONE BUT WAS NOT HOSPITALIZED. A VALVE REPLACEMENT PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO ADDRESS THE MIGRATION AND OPTIMIZE TREATMENT RESPONSE. THE PATIENT CONTINUED TO EXPERIENCE SHORTNESS OF BREATH, REQUIRING 5L NASAL CANNULA (NC) OXYGEN TO MAINTAIN STABILITY. ON (B)(6)2025, THE SUBJECT DEVELOPED PNEUMONIA, LEADING TO HOSPITAL ADMISSION THE SAME DAY. DURING HOSPITALIZATION, THE PATIENT WAS TREATED WITH SOLU-MEDROL, FOLLOWED

  Patient problems: Dyspnea; Loss of consciousness; Pneumonia; Respiratory Failure; Respiratory Insufficiency; Sepsis

  MAUDE report 22470826 ↗
• InjuryJul 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT AFTER HAVING VALVES REPLACED, THE PATIENT DEVELOPED SEVERE DYSPNEA AND HYPOXEMIC RESPIRATORY FAILURE. A CHEST X-RAY SHOWED LARGE BASILAR PNEUMOTHORAX SECONDARY TO ATELECTASIS OF THE TARGET LOBE AND A CHEST TUBE WAS INSERTED.

  Patient problems: Pneumothorax

  MAUDE report 22411454 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT MULTIPLE SPIRATION VALVE PLACEMENT IN THE LEFT LOWER LOBE UNDER GENERAL ANESTHESIA. ONE 9 MM VALVE WAS PLACED IN LB6, ONE 7 MM VALVE WAS PLACED IN LB8, ONE 7 MM VALVE WAS PLACED IN LB9, ONE 5 MM VALVE WAS PLACED IN LB10, ONE 7 MM VALVE WAS PLACED IN LB7, AND LASTLY, ONE 5 MM WAS PLACED IN LB10. A FEW MONTHS POST PROCEDURE THE PATIENT HAD AN ACUTE CHRONIC OBSTRUCTIVE PULMONARY DISEASE EXACERBATION THAT THE REPORTER CONSIDERED LIFE THREATENING AND REQUIRED HOSPITALIZATION FOR FOUR DAYS WHERE THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE PATIENT WAS LATER DISCHARGED TO HOME WITH AUGMENTIN AND A PREDNISONE TAPER. THE EVENT WAS CONSIDERED RESOLVED WITHOUT "SEQUELAE". ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER THAT WITHIN 24-48 HOURS OF DISCHARGE, THE PATIENT'S SYMPTOMS STARTED AGAIN AND WORSENED OVER A FEW DAYS. PATIENT CONTINUED TO COMPLAIN OF DYSPNEA WITH EXERTION. PATIENT WAS NOTED TO HAVE OXYGEN SATURATION AT AROUND 85% ON ROOM AIR. PATIENT ALSO ENDORSES TO SOME MILD ORTHOPNEA. IN THE EMERGENCY DEPARTMENT, RECEIVED SOLU-MEDROL 125 MG IV, LASIX 20 MG ONCE, AND ALBUTEROL AND DUONEB TREATMENT. LABS SHOW MILDLY ELEVATED D-DIMER DURING WHICH FOLLOW-UP

  Patient problems: Chronic Obstructive Pulmonary Disease (COPD); Respiratory Insufficiency

  MAUDE report 22311390 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE ASPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH COMPLAINTS OF SHORTNESS OF BREATH (SOB). THE PATIENT REPORTED HEMOPTYSIS, COUGH AND WEAKNESS SINCE BEING DISCHARGED AFTER INITIAL VALVE PLACEMENT. PRIOR TO THE ED VISIT, THE PATIENT WAS SCHEDULED FOR A REPEAT BRONCHOSCOPY DUE TO CONTINUED HEMOPTYSIS BUT THE SOB WORSENED PROMPTING AN EMERGENCY ROOM VISIT. THE INITIALLY REPORTED ADVERSE EVENTS OF HEMOPTYSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION AND PNEUMONIA WERE DETERMINED BY THE TREATING PHYSICIAN TO BE UNRELATED TO THE DEVICE. A CHEST X-RAY IN THE ED SHOWED PERSISTENT EMPHYSEMA WITH LEFT SIDED ENDOBRONCHIAL VALVES AND LEFT UPPER LOBE (LUL) COLLAPSE AND INCREASED OPACITY IN THE LEFT LUNG BASE. IT WAS CONFIRMED THAT THE PNEUMONIA WAS NOT IN THE LUNG WITH THE SUBJECT DEVICE. THE PATIENT RECEIVED CEFTRIAXONE, AZ

  Patient problems: Hemoptysis

  MAUDE report 22310578 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR A PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. STRIVE IS A SINGLE-ARM, PROSPECTIVE, MULTI-CENTER, REGISTRY STUDY TO EVALUATE THE LONG-TERM SAFETY AND EFFECTIVENESS OF THE SPIRATION VALVE SYSTEM (SVS) FOR THE TREATMENT OF SEVERE EMPHYSEMA IN A POST-MARKET SETTING. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT (ED) WITH COMPLAINTS OF SHORTNESS OF BREATH (SOB). THE PATIENT REPORTED HEMOPTYSIS, COUGH AND WEAKNESS SINCE BEING DISCHARGED AFTER INITIAL VALVE PLACEMENT. PRIOR TO THE ED VISIT, THE PATIENT WAS SCHEDULED FOR A REPEAT BRONCHOSCOPY DUE TO CONTINUED HEMOPTYSIS BUT THE SOB WORSENED PROMPTING AN EMERGENCY ROOM VISIT. THE INITIALLY REPORTED ADVERSE EVENTS OF HEMOPTYSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) EXACERBATION AND PNEUMONIA WERE DETERMINED BY THE TREATING PHYSICIAN TO BE UNRELATED TO THE DEVICE. A CHEST X-RAY IN THE ED SHOWED PERSISTENT EMPHYSEMA WITH LEFT SIDED ENDOBRONCHIAL VALVES AND LEFT UPPER LOBE (LUL) COLLAPSE AND INCREASED OPACITY IN THE LEFT LUNG BASE. IT WAS CONFIRMED THAT THE PNEUMONIA WAS NOT IN THE LUNG WITH THE SUBJECT DEVICE. THE PATIENT RECEIVED CEFTRIAXONE, AZI

  Patient problems: Hemoptysis

  MAUDE report 22310490 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. SIX ASPIRATION VALVES WERE IMPLANTED INTO THE LEFT UPPER LOBE ON (B)(6) 2025. THE THERAPEUTIC PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT DEVELOPED A PNEUMOTHORAX FOLLOWING THE PLACEMENT OF THE VALVES WHICH WAS NOTED ON POST OP CHEST X RAY THE SAME DAY. CHEST TUBE PLACEMENT WAS PERFORMED TO TREAT THE PNEUMOTHORAX. EVENT RESOLVED WITHOUT SEQUALAE ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED HOME ON THE SAME DAY, AND WAS REPORTED TO BE DOING WELL. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21939757 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS NOTIFIED OF AN ADVERSE EVENT FOR PATIENT PARTICIPATING IN THE STRIVE POST MARKET REGISTRY STUDY. SIX SPIRATION VALVES WERE IMPLANTED INTO THE LEFT UPPER LOBE ON (B)(6) 2025 . THE THERAPEUTIC PROCEDURE WAS COMPLETED WITHOUT DELAY. THE PATIENT DEVELOPED A PNEUMOTHORAX FOLLOWING THE PLACEMENT OF THE VALVES WHICH WAS NOTED ON POST OP CHEST X RAY THE SAME DAY. CHEST TUBE PLACEMENT WAS PERFORMED TO TREAT THE PNEUMOTHORAX. EVENT RESOLVED WITHOUT SEQUALAE ON (B)(6) 2025 AND THE PATIENT WAS DISCHARGED HOME ON THE SAME DAY, AND WAS REPORTED TO BE DOING WELL. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 21939537 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Pneumothorax; Unspecified Infection

  MAUDE report 21596497 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA SOCIAL MEDIA (FACEBOOK) THAT AFTER HAVING TWO VALVES PLACED ABOUT A YEAR AGO, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN WHICH CONFIRMED THE VALVES HAD SHIFTED. THE TWO VALVES WERE REMOVED FROM THE LEFT LOWER LOBE AND FOUR VALVES WERE PLACED IN THE PATIENT'S UPPER LOBE. THE FOLLOWING DAY, THE PATIENT¿S LUNG COLLAPSED, AND A CHEST TUBE WAS INSERTED. SHORTLY AFTER, THE PATIENT¿S LUNG RIPPED, REQUIRING A SECOND CHEST TUBE PLACEMENT. THE PATIENT DEVELOPED AN INFECTION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A FIFTH VALVE WAS IMPLANTED IN THE LOWER LOBE, AND THE PATIENT'S LUNG COLLAPSED AGAIN. THE PATIENT REMAINED IN THE ICU FOR A TOTAL OF 16 DAYS. THE PATIENT WAS DISCHARGED WITH ONE CHEST TUBE, WHICH HAS SINCE BEEN REMOVED.

  Patient problems: Pneumothorax; Unspecified Infection

  MAUDE report 21596426 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA SOCIAL MEDIA (FACEBOOK) THAT AFTER HAVING TWO VALVES PLACED ABOUT A YEAR AGO, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN WHICH CONFIRMED THE VALVES HAD SHIFTED. THE TWO VALVES WERE REMOVED FROM THE LEFT LOWER LOBE AND FOUR VALVES WERE PLACED IN THE PATIENT'S UPPER LOBE. THE FOLLOWING DAY, THE PATIENT¿S LUNG COLLAPSED, AND A CHEST TUBE WAS INSERTED. SHORTLY AFTER, THE PATIENT¿S LUNG RIPPED, REQUIRING A SECOND CHEST TUBE PLACEMENT. THE PATIENT DEVELOPED AN INFECTION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A FIFTH VALVE WAS IMPLANTED IN THE LOWER LOBE, AND THE PATIENT'S LUNG COLLAPSED AGAIN. THE PATIENT REMAINED IN THE ICU FOR A TOTAL OF 16 DAYS. THE PATIENT WAS DISCHARGED WITH ONE CHEST TUBE, WHICH HAS SINCE BEEN REMOVED.

  Patient problems: Pneumothorax; Unspecified Infection

  MAUDE report 21596252 ↗
• InjuryMar 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA SOCIAL MEDIA (FACEBOOK) THAT AFTER HAVING TWO VALVES PLACED ABOUT A YEAR AGO, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN WHICH CONFIRMED THE VALVES HAD SHIFTED. THE TWO VALVES WERE REMOVED FROM THE LEFT LOWER LOBE AND FOUR VALVES WERE PLACED IN THE PATIENT'S UPPER LOBE. THE FOLLOWING DAY, THE PATIENT¿S LUNG COLLAPSED, AND A CHEST TUBE WAS INSERTED. SHORTLY AFTER, THE PATIENT¿S LUNG RIPPED, REQUIRING A SECOND CHEST TUBE PLACEMENT. THE PATIENT DEVELOPED AN INFECTION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A FIFTH VALVE WAS IMPLANTED IN THE LOWER LOBE, AND THE PATIENT'S LUNG COLLAPSED AGAIN. THE PATIENT REMAINED IN THE ICU FOR A TOTAL OF 16 DAYS. THE PATIENT WAS DISCHARGED WITH ONE CHEST TUBE, WHICH HAS SINCE BEEN REMOVED.

  Patient problems: Pneumothorax; Unspecified Infection

  MAUDE report 21596215 ↗
• InjuryMar 13, 2025Migration; Migration

  IT WAS REPORTED VIA SOCIAL MEDIA (FACEBOOK) THAT AFTER HAVING TWO VALVES PLACED ABOUT A YEAR AGO, THE PATIENT UNDERWENT A COMPUTED TOMOGRAPHY (CT) SCAN WHICH CONFIRMED THE VALVES HAD SHIFTED. THE TWO VALVES WERE REMOVED FROM THE LEFT LOWER LOBE AND FOUR VALVES WERE PLACED IN THE PATIENT'S UPPER LOBE. THE FOLLOWING DAY, THE PATIENT¿S LUNG COLLAPSED, AND A CHEST TUBE WAS INSERTED. SHORTLY AFTER, THE PATIENT¿S LUNG RIPPED, REQUIRING A SECOND CHEST TUBE PLACEMENT. THE PATIENT DEVELOPED AN INFECTION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU). A FIFTH VALVE WAS IMPLANTED IN THE LOWER LOBE, AND THE PATIENT'S LUNG COLLAPSED AGAIN. THE PATIENT REMAINED IN THE ICU FOR A TOTAL OF 16 DAYS. THE PATIENT WAS DISCHARGED WITH ONE CHEST TUBE, WHICH HAS SINCE BEEN REMOVED.

  Patient problems: Pneumothorax; Unspecified Infection

  MAUDE report 21595995 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

  Patient problems: Respiratory Failure; Unspecified Infection

  MAUDE report 21573301 ↗
• InjuryFeb 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT PROCEDURE FOR THE TREATMENT OF SEVERE EMPHYSEMA. A TOTAL OF TWO SPIRATION VALVES WERE PLACED IN THE LEFT UPPER LUNG LOBE; ONE 9MM VALVE WAS PLACED AT LB1+2 AND ONE 7MM VALVE WAS PLACED AT LB4+5. THE PATIENT HAD ACUTE ON CHRONIC RESPIRATORY FAILURE WITH HYPOXIA AND HYPERCAPNIA ONE DAY POST PROCEDURE. THE PATIENT WAS TREATED WITH IV ANTIBIOTIC, STEROIDS, AND MECHANICAL VENTILATION. BOTH OF VALVES WERE REMOVED ON TWO DAYS POST PROCEDURE. THE EVENT WAS REPORTED TO BE ONGOING; THE PATIENT'S CONDITION WAS STABLE AT THE TIME OF THIS REPORT. THE PHYSICIAN INDICATED THAT THE EVENT WAS RELATED TO THE DEVICES AND PROCEDURE.

  Patient problems: Hypoxia; Respiratory Failure

  MAUDE report 21426936 ↗
• InjuryFeb 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: Pneumothorax

  MAUDE report 21413039 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P180007. One submission often covers many models, so check the product and lot details in each record.

• Z-0551-2022 · Dec 23, 2021 · Open, Classified
  Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation Model Number: SVS-V9-00