Shiley 8DICFENRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 60884522005338), received between Feb 1, 2021 and May 6, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Defective Component” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2022Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  ACCORDING TO THE REPORTER, THERE WAS INSERTION OF A SIZE 8 INNER CANNULA IN A PATIENT WITH A SIZE 10 CANNULA. THE SIZE OF THE CANNULA WAS NOT RECOGNIZABLE ON THE CANNULA AND THE COLOR-CODED SIZE DISTINCTIONS ON THE PACKAGING AND THE INNER CANNULAS WERE NOT CLEAR. THE VENTILATOR WAS ADJUSTED SO THAT THE RESISTANCE COMPENSATED FOR THE NARROWEST POINT SINCE THE INNER CANNULA HAD A DIFFERENT DIAMETER THAN THE OUTER CANNULA. THE PATIENT TENDED TO "GET WORSE AIR" BUT NO SERIOUS CONSEQUENCES AROSE AND THE PATIENT WAS CONSISTENTLY STABLE. THE PATIENT HAD BEEN WEANING FROM THE VENTILATOR FOR ALMOST 40 DAYS AFTER A COVID INFECTION.

  Patient problems: Dyspnea

  MAUDE report 14296204 ↗
• MalfunctionApr 22, 2022Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CANNULAS ARE OUT OF ALIGNMENT AND IT WAS INSERTED FOR ONLY 15 SECONDS. IT COULD NOT BE TRACED WHY THERE WAS A DROP IN SPO2 WHEN THE OO2 SPEAKER ATTACHMENT WAS APPLIED (PHONATE SPEAKING VALVE FOR USE WITH LOW-FLOW OXYGEN PORT). THE PATIENT WAS DECANNULATED.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 14187788 ↗
• MalfunctionApr 22, 2022Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE CANNULAS ARE OUT OF ALIGNMENT AND IT WAS INSERTED FOR ONLY 15 SECONDS. IT COULD NOT BE TRACED WHY THERE WAS A DROP IN SPO2 WHEN THE OO2 SPEAKER ATTACHMENT WAS APPLIED (PHONATE SPEAKING VALVE FOR USE WITH LOW-FLOW OXYGEN PORT). FURTHERMORE, IT WAS DETERMINED THAT THE PATIENT EXPERIENCED DYSPNEA. THE PATIENT WAS DECANNULATED.

  Patient problems: Dyspnea; Low Oxygen Saturation; Unintended Extubation

  MAUDE report 14187682 ↗
• MalfunctionFeb 1, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIFFERENCE BETWEEN TWO INNER CANNULA LOT NUMBERS, THE NEW INNER CANNULA DID NOT HAVE THE SAME WINDOW DIMENSIONS AS THE CANNULA. THIS CREATED WHEEZING WHEN THE PATIENT IS ON OXYGEN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259998 ↗
• MalfunctionFeb 1, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THERE WAS A DIFFERENCE BETWEEN TWO INNER CANULA LOT NUMBERS, THE NEW INNER CANNULA DID NOT HAVE THE SAME WINDOW DIMENSIONS AS THE CANNULA. THIS CREATED WHEEZING WHEN THE PATIENT WAS ON OXYGEN. IT WAS STATED THAT RE-CANNULATION OR REPLACEMENT OF THE TUBE WAS NOT PERFORMED TO THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11259111 ↗

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-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-1464-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• Z-1470-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA
• 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-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-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-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-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-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-1476-2010 · Apr 13, 2010 · Terminated
  Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton,
• 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-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-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-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

…and 8 more.