Spiration Valve System SVS-V5-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00896506002286), received between Jul 10, 2020 and Mar 18, 2026 — classified as 12 injuries.

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMar 18, 2026Adverse Event Without Identified Device or Use Problem

  REPORT 6 OF 6. 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. ON (B)(6) 2024, THE PATIENT UNDERWENT A THERAPEUTIC BRONCHOSCOPIC LUNG VOLUME REDUCTION PROCEDURE DURING WHICH MULTIPLE SPIRATION VALVES WERE PLACED. FOUR 9MM VALVES AND TWO 5MM VALVES WERE PLACED IN AN UNSPECIFIED LOBE/LOCATION. ON (B)(6) 2026, THE PATIENT EXPERIENCED COUGH, SHORTNESS OF BREATH AND FEVER. A SPUTUM CULTURE WAS PERFORMED WHICH IDENTIFIED VERY LIGHT GROWTH OF STENOTROPHOMONAS MALTOPHILIA. THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA, RECEIVED ANTIBIOTIC TREATMENT, AND THE ENDOBRONCHIAL VALVES WERE REMOVED. THE PATIENT IMPROVED AND WAS DISCHARGED ON AN UNSPECIFIED DATE.

  Patient problems: Pneumonia

  MAUDE report 24635657 ↗
• 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 22310498 ↗
• InjuryMay 31, 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: Chest Pain; Hemoptysis; Pneumothorax

  MAUDE report 22120508 ↗
• InjuryMay 31, 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: Chest Pain; Hemoptysis; Pneumothorax

  MAUDE report 22120506 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

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

  MAUDE report 21182049 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

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

  MAUDE report 21181818 ↗
• InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

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

  MAUDE report 21181077 ↗
• InjuryMar 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD FOUR SPIRATION VALVES PLACED ON (B)(6) 23. ON (B)(6) 23 PATIENT DEVELOPED A SMALL LEFT APICAL PNEUMOTHORAX, WHICH RESOLVED WITHOUT INTERVENTION WITHIN TWO DAYS. SEVEN DAYS AFTER SURGERY PATIENT DEVELOPED A NEW LARGE PNEUMOTHORAX WITH ATELECTASIS OF THE LEFT LUNG AND RIGHTWARD MEDIASTINAL SHIFT. CHEST TUBE WAS PLACED AND AFTER SUBSEQUENT X-RAY, MEDICAL TEAM INSERTED AN INTERIM LEFT-SIDED PLEURAL-BASED PIGTAIL CATHETER IN SITU. HOSPITAL STAY WAS PROLONGED. ON (B)(6) 23, DOCTOR STATED THAT PATIENT HAD NO AIR LEAK IN THE INFERIOR CHEST TUBE, HAD DECREASED DIMINISHING FLUID, AND THAT CHEST X-RAY WAS IMPROVED. DOCTOR STATED THAT THE PATIENT WAS OVERALL IMPROVED. PATIENT WAS RELEASED ON (B)(6) 23 WITH HEIMLICH VALVE IN PLACE. PNEUMOTHORAX RESOLVED, AND PATIENT RETURNED TO HAVE THE HEIMLICH VALVE REMOVED ABOUT A WEEK LATER, (B)(6) 23. SPIRATION VALVES REMAIN IN PLACE.

  Patient problems: Pneumothorax

  MAUDE report 16500064 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT WAS TREATED FOR EMPHYSEMA WITH THE SPIRATION VALVE. PATIENT EXPERIENCED A PNEUMOTHORAX. TWO SVS-V7-00 VALVE LOTS AND ONE SVS-V5-00 LOT WERE USED. THE TOTAL NUMBER OF VALVES PLACED IS UNKNOWN AT THE TIME OF THIS REPORT.

  Patient problems: Pneumothorax

  MAUDE report 12485594 ↗
• InjuryNov 27, 2020Adverse Event Without Identified Device or Use Problem

  PATIENT CONTACTED GYRUS ACMI, INC. ONE MONTH AFTER PLACEMENT OF SPIRATION VALVE(S). PATIENT INDICATED HE EXPERIENCED POST-PROCEDURAL COMPLICATIONS AND WAS HOSPITALIZED FOR TWELVE DAYS. AFTER DISCHARGE FROM HOSPITAL HE INDICATED THAT HE WAS EXPERIENCING WEAKENING OF LEGS, SHORTNESS OF BREATH, REQUIRING HIM TO SIT DOWN TO CATCH HIS BREATH AFTER WALKING. PATIENT INDICATED HE HAD CONTACTED HIS PHYSICIAN AND WAS ADVISED TO GO TO THE EMERGENCY ROOM. NO OTHER INFORMATION AVAILABLE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10914342 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem

  PATIENT WITH SEVERE EMPHYSEMA HAD SPIRATION VALVES PLACED IN THEIR LUNG. NO PRIOR EVIDENCE OF ATELECTASIS WAS DOCUMENTED. VALVES WERE PLACED INTO RIGHT UPPER LOBE ANTERIOR, APICAL, AND POSTERIOR SUB-SEGMENTS. PATIENT DEVELOPED A PNEUMOTHORAX AN HOUR TO HOUR AND A HALF AFTER PROCEDURE WAS PERFORMED. POST-PROCEDURE CHEST X-RAY AFTER TREATMENT OF PNEUMOTHORAX SHOWED ATELECTASIS AND VOLUME LOSS. INTERVENTIONS TO TREAT PNEUMOTHORAX INCLUDED CONSCIOUS SEDATION AND INSERTED CHEST TUBE WITH IMMEDIATE RESOLUTION. PATIENT EXHIBITED NO DISTRESS. VALVES REMAIN IN THE PATIENT.

  Patient problems: Pneumothorax

  MAUDE report 10260457 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem

  PATIENT WITH SEVERE EMPHYSEMA HAD SPIRATION VALVES PLACED IN THEIR LUNG. NO PRIOR EVIDENCE OF ATELECTASIS WAS DOCUMENTED. VALVES WERE PLACED INTO RIGHT UPPER LOBE ANTERIOR, APICAL, AND POSTERIOR SUB-SEGMENTS. PATIENT DEVELOPED A PNEUMOTHORAX AN HOUR TO HOUR AND A HALF AFTER PROCEDURE WAS PERFORMED. POST-PROCEDURE CHEST X-RAY AFTER TREATMENT OF PNEUMOTHORAX SHOWED ATELECTASIS AND VOLUME LOSS. INTERVENTIONS TO TREAT PNEUMOTHORAX INCLUDED CONSCIOUS SEDATION AND INSERTED CHEST TUBE WITH IMMEDIATE RESOLUTION. PATIENT EXHIBITED NO DISTRESS. VALVES REMAIN IN THE PATIENT.

  Patient problems: Pneumothorax

  MAUDE report 10260383 ↗

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