Shiley 9CN90ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521172517), received between Oct 7, 2022 and Aug 18, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (1 report).

1 other recall cover devices cleared under the same FDA submission (K142296); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 18, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SAFETY BALLOON OF THE CANNULA HAD A LEAK BECAUSE IT WAS DAMAGED, THE PATIENT BEGAN TO DESATURATE UP TO 40%, AND THE RECOVERY WAS PROLONGED. THE FIRST CANNULA WAS KEPT IN PLACE FOR 20 MINUTES TO SEE IF THE ISSUE COULD BE RESOLVED BEFORE IT WAS REMOVED. AFTER BEING INEFFECTIVE IN RETRIEVING PATIENT OXYGENATION, THE DOCTORS TAKE THE INITIATIVE TO REMOVE THE CANNULA AND INSTALL A NEW ONE. WHEN REMOVING THE CANNULA, THE SCRUB NURSE CHECKED THE CONDITIONS AGAIN. OF THE CANNULA THAT WAS REMOVED, AND WHEN REVISING THE BALLOON, DETECTS AIR LEAKAGE, AND PERFORMS A TEST WITH THE CANNULA SUBMERGED IN SOLUTION, AND NOTICED THE SIGNIFICANT LEAK OF AIR WITH THE BALLOON. THERE WAS NO ISSUE MENTIONED IN THE EVENT ABOUT THE SECOND DEVICE.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 22835979 ↗
• MalfunctionOct 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CUFF "BURST" AND MADE A HIGH SOUND IN THE ICU. THE DEVICE WAS REPLACE THE SAME DAY AND THERE WAS NO PATIENT HARM.

  Patient problems: Unintended Extubation

  MAUDE report 15566709 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142296. One submission often covers many models, so check the product and lot details in each record.

• Z-1357-2023 · Mar 24, 2023 · Open, Classified
  Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff, and Cuffless: Disposable Inner Cannula or Reusable Inner Cannula (REF, Product Description): 10CN10H, 10.0MM SHILEY CU