Shiley SSVO (UDI 40884522005372)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 40884522005372), received between May 15, 2018 and Nov 6, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Noise, Audible” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2024Mechanical Problem; Defective Component; Physical Resistance/Sticking; Mechanical Problem; Defective Component; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING USE, THE SPEAKING VALVE COULD NOT BE DISCONNECTED FROM THE TRACHEOSTOMY, IT PRESENTED A COLLAPSED APPEARANCE AND NO VALVE DIAPHRAGM MOVEMENT DURING INSPIRATION. THE SPEAKING VALVE WAS REMOVED WITH DIFFICULTY USING EXTERNAL PROTECTION AND MANAGED TO BREATHE INDEPENDENTLY, BUT IT BECAME MORE SECRETIVE, WHICH MADE VENTILATION DIFFICULT AND MADE IT AN EMERGENCY TO REMOVE THE PROBE SO THAT HE COULD BE VACUUMED SAFELY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20620706 ↗
• MalfunctionJun 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE OXYGEN INLET CAP OF THE SPEAKING VALVE WAS LOOSED AND DETACHED EASILY WHEN THE PATIENT COUGHED AND DURING VALVE DEVELOPMENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19542649 ↗
• MalfunctionJan 23, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING THE REPORTER, DEVICE WAS IN USED FOR TWO DAYS, DURING USE, THE FILM MAKES A NOISE EVERY TIME THE PATIENT EXHALES. THE FILM/MEMBRANE MOVED AND TOUCHED THE VALVE STRUCTURE CAUSED THE NOISE. THE NOISE BOTHERED THE PATIENT TO THE POINT OF PREVENTED FROM FALLING ASLEEP/SLEEP. WHEN THE PATIENT IS LYING DOWN, THE NOISE IS GREATER. THERE WAS NO CHANGE IN THE WAY OF USE, NOR IN THE PATIENT'S CONDITIONS, BUT THE DURABILITY WAS EXTREMELY REDUCED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 16225733 ↗
• MalfunctionJan 23, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING THE REPORTER, DURING USE, THE FILM MAKES A NOISE EVERY TIME THE PATIENT EXHALES. THE FILM/MEMBRANE MOVED AND TOUCHED THE VALVE STRUCTURE CAUSED THE NOISE. THE NOISE BOTHERED THE PATIENT TO THE POINT OF PREVENTED FROM FALLING ASLEEP/SLEEP. WHEN THE PATIENT WAS LAY DOWN, THE NOISE WAS GREATER. THERE WAS NO CHANGE IN THE WAY OF USE, NOR IN THE PATIENT'S CONDITIONS, BUT THE DURABILITY WAS EXTREMELY REDUCED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 16225501 ↗
• MalfunctionFeb 23, 2022Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, THE PILOT VALVE HAD A DIMENSIONAL ISSUE AS THE SOUND WAS NOT COMING OUT CORRECTLY, THE VOICE WAS LOW. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13585206 ↗
• MalfunctionDec 21, 2018Noise, Audible; Noise, Audible

  ACCORDING TO THE REPORTER, THE DEVICE WAS A NEWLY OPENED ONE AND IT GAVE OUT WEIRD NOISE WHEN ATTACHED TO THE PATIENT'S TRACHEOSTOMY TUBE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8192008 ↗
• 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 8032618 ↗
• MalfunctionMay 15, 2018Noise, Audible; Noise, Audible

  ACCORDING TO THE REPORTER, THE DEVICE'S SPEAKING VALVE PRODUCED A SOUND WHEN USED. THE CUSTOMER REPORTED THAT PATIENT HAD NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7517072 ↗