Shiley 8IC85Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521511934), received between Mar 11, 2020 and Feb 20, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (5 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2024Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE WAS DEFECTIVE. THE CANNULA WAS DIFFICULT TO TAKE IN/OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18740995 ↗
• MalfunctionJan 2, 2024Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S INNER CANNULA EASILY DISLODGES. THE PATIENT COUGHED AND THE INNER CANNULA "POPPED" OUT AND LANDED ON THE PATIENT CHEST. AFTER IT WAS REPLACED, IT WOULD SLIDE IN AND OUT WITH MOVEMENT. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18431885 ↗
• InjuryJul 20, 2023Material Separation; Material Separation

  ACCORDING TO THE REPORTER, A TRACHEOSTOMIZED PATIENT HAD "BALLISTIC TRAUMA" WITH THE TRACH INNER CANNULA "8UN85A" REQUIRING A CHANGE OF DISPOSABLE INNER LINER "8IC85" EVERY 10 DAYS DUE TO GETTING SPLIT IN TWO LENGTHWAYS.

  Patient problems: Unintended Extubation; Unspecified Tissue Injury

  MAUDE report 17363947 ↗
• MalfunctionJun 20, 2023Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA SPLITS INTO TWO LENGTHWISE DURING USE. IT WAS ALSO STATED THAT THE CANNULA WAS INCORRECTLY USE AND REPLACED EVERY TEN DAYS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17166422 ↗
• MalfunctionJun 20, 2023Use of Device Problem; Human-Device Interface Problem; Use of Device Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE INNER CANNULA SPLITS INTO TWO LENGTHWISE DURING USE AND BEING REPLACED EVERY TEN DAYS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164868 ↗
• MalfunctionFeb 7, 2023Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, PATIENT HAD A COMPLAINT ABOUT THE NEW VERSION OF THE TRACH DESIGN. THE NEW INNER CANNULA WERE HARDER TO CLEAN AND UNABLE TO BREATH FREELY UNLIKE USING THE OLDER DESIGN TRACH AND INNER CANNULA. THE NEWER TRACH ALSO POINTED DOWN FARTHER AND GETS CAUGHT ON PATIENTS SHIRT. PATIENTS HEALTH WAS STABLE AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16315620 ↗
• MalfunctionJul 7, 2022Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING ROUTINE REPLACEMENT OF THE INNER CANNULA, IT WAS FOUND THAT THE INNER CANNULA WAS RUPTURED, AND THE INTEGRITY OF THE INNER CANNULA WAS CHECKED, AND NO FRAGMENTS FELL OFF. IMMEDIATELY REPLACED IT WITH THE NEW INNER CANNULA TO USE FOR THE PATIENT, WITHOUT AFFECTING THE PATIENT'S CONDITION.

  Patient problems: Unintended Extubation

  MAUDE report 14945310 ↗
• MalfunctionOct 19, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INNER CANNULA OF THE DEVICE WAS GETTING STUCK INSIDE THE PATIENT'S TRACHEOSTOMY. IT WAS STATED THAT THE DEVICE WAS DIFFICULT TO ACTUALLY GRASP, PINCH AND PULL ON THE INNER CANNULA AND SOME HAD TO USE HEMOSTATS TO REPLACE THE INNER CANNULA. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656771 ↗
• MalfunctionJun 17, 2021Crack; Crack

  ACCORDING TO THE REPORTER, THE PRODUCT CRACKED WHEN IT WAS MANIPULATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12017379 ↗
• MalfunctionDec 30, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING USE, THE SECRETIONS GOT STUCK IN INNER CANNULA. PATIENT WAS VENTILATED WITH HEATED HUMIDITY, LOTS OF SECRETIONS, INNER CANNULA CHANGED EVERY 8 HRS. SECRETIONS VISIBLE AT THE PATIENT WYE. CHANGING OF INNER CANNULA WAS VERY DIFFICULT TO REMOVE AND REQUIRED SEVERAL ATTEMPTS. INNER CANNULA WAS REMOVED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11095174 ↗
• InjuryMar 11, 2020Labelling, Instructions for Use or Training Problem; Human-Device Interface Problem; Labelling, Instructions for Use or Training Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, DURING USE, PATIENT WAS UNABLE TO FINGER OCCLUDE THE TRACH TO TALK DUE TO THE SLIT IN THE INNER CANNULA. IT WAS ALSO REPORTED THAT THE MARKINGS ON THE FLANGE OF THE TRACH RUBBED OFF COMPLETELY TO THE POINT THE TRACH WAS UNRECOGNIZABLE. DUE TO SAFETY CONCERN, THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 9819049 ↗

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