Shiley SSVO (UDI 40884522007734)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 40884522007734), received between Mar 29, 2018 and Nov 16, 2018 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (4 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2018Noise, Audible; Noise, Audible

  ACCORDING TO THE REPORTER, THE UNITS WERE GENERATING A 'SSSSST" SOUND WHEN IT'S BEING USED. THE CUSTOMER REPORTED THAT THE PATIENT HAD DIFFICULTY BREATHING WHEN USING THE DEVICE.

  Patient problems: Dyspnea

  MAUDE report 8081056 ↗
• InjuryNov 2, 2018Noise, Audible; Noise, Audible

  ACCORDING TO THE REPORTER, THE UNITS WERE GENERATING A 'SSSSST" SOUND WHEN IT'S BEING USED. THE CUSTOMER REPORTED THAT THE PATIENT HAD DIFFICULTY BREATHING WHEN USING THE DEVICE.

  Patient problems: Dyspnea

  MAUDE report 8032597 ↗
• MalfunctionAug 21, 2018Noise, Audible; Noise, Audible

  ACCORDING TO THE REPORTER, THE UNIT GAVE OUT A LOUD NOISE WHEN THE PATIENT EXHALED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7801753 ↗
• MalfunctionMar 29, 2018Noise, Audible; Noise, Audible

  ACCORDING TO THE REPORTER, UPON FITTING THE DEVICE ONTO THE PATIENT'S TRACHEOSTOMY TUBE, IT IMMEDIATELY GAVE OUT LOUD NOISE AND THEY HAD TO TAKE IT OFF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7384025 ↗