Shiley SSV (UDI 10884521751354)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521751354), received between Mar 20, 2020 and Aug 7, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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. 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.

• MalfunctionAug 7, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE SPEAKING VALVE'S INNER DIAMETER WAS TOO LARGE TO FIT OVER THE OUTER DIAMETER OF THE TRACHEOSTOMY TUBE. IT DOES NOT FIT SNUGGLY OVER THE TRACH AND SLIDES OFF VERY EASILY. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17477022 ↗
• MalfunctionSep 27, 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 15491420 ↗
• MalfunctionDec 7, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE VOICE VALVE COULD NOT BE INSERTED. IT WOULD NOT GRIP THE TRACHEOSTOMY TUBE QUICKLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12952252 ↗
• MalfunctionMar 20, 2020Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE DEVICE HAD DEFECTIVE VALVE. THE CUSTOMER STATED THAT, AS ROUTINELY, THE SPOUSE HAS REPLACED THE OLD ONE AFTER A MONTH, AND REPLACED IT WITH A NEW DEVICE, THIS HAS BEEN DONE AND AS IT WAS INSTALLED, THE PATIENT HAS RAISED HANDS TO POINT OUT THAT HE IS SUFFOCATING. THE SPOUSE REMOVED THE NEW DEVICE AND HE STARTED TO BREATH PROPERLY. THE WIFE REPLACED AND PUT BACK THE OLD DEVICE AND NO ISSUES WERE NOTICED. AFTER SEVERAL DAYS THE SPOUSE WANTED TO TRY THE SUPPOSED DEFECTED DEVICE AGAIN, AND THUS, REPLACED IT AND AGAIN THE HUSBAND COULD HARDLY BREATH.

  Patient problems: Dyspnea

  MAUDE report 9859599 ↗