Shiley SSV (UDI 40884522005365)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 40884522005365), received between Nov 29, 2018 and Nov 14, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE SPEAKING VALVE WAS NOTICED A HOLE, WHEREIN THE PATIENT CAN BREATHE THROUGH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20683222 ↗
• MalfunctionOct 26, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PRODUCT WAS INSTALLED WITH INNER CANNULA IN PLACE AND WAS NOT STAYING ON THE TRACHEOSTOMY TUBE. THE SPEAKING VALVE WAS NOT USE AT ALL AS IT DIDN¿T FIT AND IT WAS FALLING OFF AS IT WAS TOO LOOSE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15672886 ↗
• MalfunctionOct 3, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, IT WAS STATED THAT WHEN THE PATIENT COUGH'S THE DEVICE WOULD COME OFF THE TRACH. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 15528512 ↗
• MalfunctionSep 26, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THE SPEAKING VALVE WAS UNABLE TO SIT ON THE TRACH WITH THE INNER CANNULA IN PLACE. THE DEVICE HAD TO BE CHANGED TO A NEW ONE. MULTIPLE BRAND-NEW SPEAKING VALVES AND INNER CANNULAS WERE ATTEMPTED. THE SPEAKING VALVES WORKED FINE WITH OTHER TUBES. THE PROBLEM SEEMS TO BE AN ISSUE WITH THE TAPERING OF THE 15-MM TRACHEAL CONNECTION, WHICH ALLOWS THE SPEAKING VALVE TO SLIDE TOO FAR AND THE INNER CANNULA TO HIT THE BOTTOM OF THE SPEAKING VALVE, PREVENTING SEATING. THE DEVICE WAS ABLE TO CONNECT TO THE VENTILATOR CIRCUIT, BUT THE SPEAKING VALVE WAS LOOSE TO THE POINT OF FALLING OFF WITH BREATHING. THE PATIENT WAS BREATHING SPONTANEOUSLY. HOWEVER, THE PATIENT WOULD BE MECHANICALLY VENTILATED AT OTHER TIMES DURING THE DAY AS THE PATIENT WAS PARTICIPATING IN TRACH HOOD TRIALS. THE PATIENT WAS LIKELY RECEIVING AEROSOLIZED MEDICATIONS PRIMARILY WHILE ON THE VENTILATOR, AND NOT WITH THE TRACH HOOD OR SPEAKING VALVE IN PLACE.

  Patient problems: Unintended Extubation

  MAUDE report 15486458 ↗
• MalfunctionJun 11, 2021Ambient Noise Problem; Ambient Noise Problem

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A CLICKING NOISE DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11987841 ↗
• MalfunctionNov 29, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE SPEAKING VALVE SHOOTS ACROSS THE ROOM WHEN PATIENT COUGHS. THE PATIENT WANTS TO KNOW IF THERE IS A WAY TO SECURE THE TRACH ACCESSORY. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8114038 ↗