Shiley 8CFNRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 50884522006932), received between Dec 21, 2018 and Aug 7, 2024 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Defective Component” (5 reports).

23 other recalls cover devices cleared under the same FDA submission (K962173); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE PATIENT FELT DISCOMFORT WHEN WEARING THE TRACHEOSTOMY CANNULA WHICH LED TO SLIGHT BLEEDING. WHEN THE CANNULA WAS REMOVED, THE PATIENT NOTICED THAT THE INNER CANNULA WAS LONGER THAN THE BODY OF THE CANNULA BY A FEW MILLIMETER AND CAUSED A PROTRUDING END INJURING THE INNER PART OF THE TRACHEA. THE ENTIRE TRACHEOSTOMY WAS REPLACED.

  Patient problems: Discomfort; Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 19927385 ↗
• MalfunctionNov 9, 2023Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE NEWLY OPEN TRACHEOSTOMY TUBE WITH OBTURATOR DID NOT ALIGN PROPERLY BEFORE USE. BUT WHEN THE NEW OBTURATOR WAS ATTACH TO THE OLD TUBE THAT HAD BEEN REMOVED IT FIT NICELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103842 ↗
• MalfunctionOct 26, 2022Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE CANNULAS WAS LONGER THAN THE OUTER CANNULA AND THE EDGE WAS SHARP, WHILE ONE INNER CANNULA WAS ADDITIONALLY DAMAGED AS IT WAS BENT INWARDS. AND IT COULD NOT BE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673928 ↗
• MalfunctionOct 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE CANNULAS WERE LONGER THAN THE OUTER CANNULA AND THE EDGE WAS SHARP, WHILE ONE INNER CANNULA WAS ADDITIONALLY DAMAGED AS IT WAS BENT INWARDS. AND IT COULD NOT BE USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670512 ↗
• MalfunctionOct 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE CANNULAS WAS LONGER THAN THE OUTER CANNULA AND THE EDGE WAS SHARP, WHILE ONE INNER CANNULA WAS ADDITIONALLY DAMAGED AS IT WAS BENT INWARDS. AND IT COULD NOT BE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670508 ↗
• MalfunctionOct 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE THREE CANNULAS WAS LONGER THAN THE OUTER CANNULA AND THE EDGE WAS SHARP, WHILE ONE INNER CANNULA WAS ADDITIONALLY DAMAGED AS IT WAS BENT INWARDS. AND IT COULD NOT BE USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15670197 ↗
• MalfunctionFeb 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANULA WAS LONGER THAN THE CANULA. THE PATIENT WAS DECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 13477150 ↗
• MalfunctionFeb 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INNER CANULA WAS LONGER THAN THE CANULA. THE PATIENT WAS DECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 13477141 ↗
• MalfunctionDec 12, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE OBTURATOR DID NOT SEAL THE OUTER CANNULA COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10995562 ↗
• InjuryFeb 20, 2020Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS AN INNER CANNULA SEPARATION. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 9735253 ↗
• MalfunctionFeb 6, 2019Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE DEVICE¿S INNER CANNULA DID NOT CLIP THE OUTER CANNULA. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: No Information

  MAUDE report 8310031 ↗
• MalfunctionDec 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE DEVICE'S INNER CANNULA WAS LONGER THAN THE OUTER CANNULA AND THE PATIENT FELT PAIN IN TRACHEA. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Information

  MAUDE report 8191119 ↗
• MalfunctionDec 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE DEVICE'S INNER CANNULA WAS LONGER THAN THE OUTER CANNULA AND THE PATIENT FELT PAIN IN TRACHEA. THE CUSTOMER REPORTED THAT PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Information

  MAUDE report 8191113 ↗
• MalfunctionDec 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE DEVICE'S INNER CANNULA WAS LONGER THAN THE OUTER CANNULA AND THE PATIENT FELT PAIN IN TRACHEA. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Information

  MAUDE report 8191093 ↗
• MalfunctionDec 21, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, THE DEVICE'S INNER CANNULA WAS LONGER THAN THE OUTER CANNULA AND THE PATIENT FELT PAIN IN TRACHEA. PATIENT OUTCOME WAS UNKNOWN.

  Patient problems: No Information

  MAUDE report 8191069 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962173. One submission often covers many models, so check the product and lot details in each record.

• Z-2174-2012 · Jul 18, 2012 · Terminated
  Shiley Reusable Cannula Low Pressure Cuffed Tracheostomy Tubes, model numbers (Worldwide) 8LPC, 8FEN; (Outside U.S.) 8FENJ, 8FENJ-S, 8LPC-S, 8FEN-S. Product Usage: The product
• Z-1491-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Inten
• Z-1481-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1467-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1472-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1477-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• Z-1468-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1480-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1488-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1469-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for byp
• Z-1479-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• Z-1489-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend
• Z-1466-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypa
• Z-1471-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• Z-1490-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intend

…and 8 more.