Spiration Valve System HUS-C26NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00896506002187), received between May 13, 2023 and Jun 23, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Failure to Eject” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT SPIRATION VALVE PLACEMENT FOR THE TREATMENT OF AIR LEAK ON (B)(6) 2023. DURING THE PROCEDURE, THE PHYSICIAN NOTED THAT THE LOADED VALVE (HUS-V6) WAS POPPING OUR OR NOT FULLY INSERTED IN THE DEPLOYMENT CATHETER (HUS-C26N). THE VALVE WAS REMOVED FROM THE DEPLOYMENT CATHETER. AS A NEW VALVE (HUS-V9) WAS BEING LOADED, THE VALVE LOADER WAS DROPPED AND DAMAGED (I.E., IT WAS BROKEN AND COULD NO LONGER BE USED). A SECOND VALVE DEPLOYMENT CATHETER AND LOADER WAS NOT AVAILABLE AT THE TIME, RESULTING IN A DELAY OF THE PROCEDURE. THE PATIENT WAS MOVED FROM THE OR TO THE ICU FOR A PERIOD OF TIME UNTIL A NEW VALVE DEPLOYMENT CATHETER AND LOADER WAS ACQUIRED. THE VALVE PLACEMENT PROCEDURE WAS ATTEMPTED AGAIN THE SAME DAY ((B)(6) 2023). THE PHYSICIAN TRIED TO IMPLANT TWO DIFFERENT SIZED VALVES (HUS-V6 AND HUS-V9) BUT WAS UNSUCCESSFUL BECAUSE THE THERAPEUTIC BRONCHOSCOPE BEING USED COULD NOT ARTICULATE THE INTENDED ANATOMY. THE NEXT DAY ((B)(6) 2023 ) THE VALVE PLACEMENT PROCEDURE WAS INITIATED FOR A THIRD TIME USING A NEW VALVE DEPLOYMENT CATHETER AND LOADER. IN ADDITION, A DIFFERENT BRONCHOSCOPE WAS USED FOR THIS PROCEDURE. VALVE PLACEMENT WAS COMPLETED SUCCESSFULLY AND THE PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17195823 ↗
• MalfunctionMay 13, 2023Failure to Eject; Failure to Eject

  PATIENT WAS TO HAVE SPIRATION VALVES (HUS-V9) PLACED FOR THE TREATMENT OF AIR LEAK (DATE UNKNOWN). PHYSICIAN USED THE SPIRATION DEPLOYMENT CATHETER AND LOADER (HUS-C26N) TO PLACE THE SPIRATION VALVES. VALVES COULD NOT BE PLACED. PHYSICAN REPORTED THREE WASTED VALVES (HUS-V9) DUE TO A MALFUNCTIONING DEPLOYMENT CATHETER AND LOADER (HUS-C26N). REPLACEMENT DEVICES WERE SENT RESULTING IN A 24-HOUR DELAY IN PROCEDURE. NO PATIENT INJURY OCCURRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16925146 ↗