Shiley SSVO (UDI 10884521751361)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521751361), received between Oct 25, 2022 and Oct 2, 2023 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE PATIENT COUGHED UP A SMALL PIECE OF PLASTIC A FEW HOURS OF BEING USE. THE NURSES WHO WERE ON DUTY, SAW IT AND DETERMINED THAT THE PIECE OF PLASTIC WAS PART OF THE SPEAKING VALVE. THE MEMBRANE OF THE SPEAKING VALVE CAME LOOSE, CAUSING SMALL PARTS TO FORM AND COME OUT. THE CANNULA WAS NOT DAMAGED, ONLY THE SPEAKING VALVE WAS REPLACED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855791 ↗
• MalfunctionJan 20, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LOOSE FIT AND ONLY FITTED WELL AFTER INNER CANNULA WAS REMOVED FROM THE TRACHEOSTOMY TUBE. ADDITIONALLY, THE ETCHING ON THE FLANGE WHICH INDICATES THE SIZE AND THE LOT NUMBER WAS NOT VISIBLE WHEN USED ON PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16214089 ↗
• MalfunctionOct 25, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, PATIENT SWITCHED THE INNER CANNULA TO A DIFFERENT SIZE AND FOUND THAT THE SPEAKING VALVE DID NOT FIT SNUGLY. THE PATIENT WAS INFORMED THAT SPEAKING VALVE WAS UNIVERSAL FOR ALL CONNECTORS. THE PATIENT WAS UNAWARE OF HOW OLD THE ORIGINAL SPEAKING VALVE WAS AND WOULD PURCHASE A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668605 ↗