Shiley 8CFSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 60884522006977), received between Jan 9, 2018 and Oct 20, 2021 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2021Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, THE COORDINATING NURSE, WHILE INSPECTING THE TUBE BEFORE INSERTION, NOTICED A JAMMING BLOCKAGE OF THE INNER CANNULA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12666059 ↗
• InjuryJul 16, 2020Material Separation; Material Separation

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD A BREAKAGE OF THE WHITE JUNCTION WITH INNER CANNULA THAT TURNED IDLE AND COULD NOT BE EXTRACTED. THE PATIENT HAD A MILD BLEEDING AND THE PROCEDURE WAS DELAYED 30 MINUTES LONGER THAN USUAL.

  Patient problems: Injury

  MAUDE report 10283287 ↗
• InjuryJul 16, 2020Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE UNIT HAD A BREAKAGE OF INNER CANNULA WHICH, BY TURNING, COULD NOT LONGER BE EXTRACTED. IT WAS INDICATED THAT THE PROCEDURE WAS DELAYED BY 30 MINUTES LONGER THAN USUAL. THE CAUSE OF THE DELAY IN CARRYING OUT THE PROCEDURE WAS THE SUDDEN BLOCK IN THE EXTRACTION OF THE COUNTER CANNULA WHICH WAS REPLACED EVERY DAY, TWICE A DAY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10282169 ↗
• InjuryMay 13, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER DURING USE, THE DEVICE HAD PHYSICAL DAMAGE. THE CANNULA WAS SUCCESSFULLY PLACED INTO THE PATIENT, HOWEVER DURING THE NIGHT, THE PATIENT SOMETIMES HAS TROUBLE GETTING AIR. THIS MADE THE PATIENT TEAR THE CANNULA OUT IN DESPERATION THREE TIMES AND AT THAT TIME THE PATIENT HAD DESTROYED THE CANNULA. AFTER THE FIRST TIME, THE CANNULA WAS DOUBLE TAPED ON, BUT THE PATIENT MANAGED TO RIP THE CANNULA OUT. AFTERWARDS, THE PATIENT CANNOT REMEMBER WHAT HAPPENED. THE FACT THAT THE CANNULA WAS RIPPED OUT, THE PATIENT HAS GIVEN SOME ACUTE SITUATIONS AND ONCE ENDED UP INTENSIVE AND WAS ABOUT TO GO INTO A CARDIAC ARREST. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Extubate; Hypoxia

  MAUDE report 10050201 ↗
• MalfunctionSep 29, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING A ROUTINE TRACHEOSTOMY CHANGE, THE OUTER CANNULA WAS PLACED IN SITU BUT WHEN THE INNER CANNULA WAS INSERTED, THEY WERE UNABLE TO LOCK IT. THEY WERE ABLE TO SUCCESSFULLY LOCK AN ALTERNATE INNER CANNULA IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9132618 ↗
• InjuryJan 30, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE'S FLANGE BROKE FROM THE OUTER CANNULA. IT WAS REPORTED THAT THE TRACH CHANGE WAS DONE AND AFTER 2 DAYS THE FLANGE CAME APART FROM THE REST OF THE TRACH AND THEY WERE ABLE TO REMOVE PORTION OF TRACH THAT REMAINED IN PATIENT AND INSERT SPARE.

  Patient problems: Extubate

  MAUDE report 8288552 ↗
• InjuryJan 9, 2018Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, DURING USE OF THE DEVICE, THE INNER CANNULA DID NOT REMAIN LOCKED ON THE OUTER CANNULA CAUSING LEAKAGE IN THE VENTILATION. ANOTHER CANNULA WAS USED. NO REPORTED PATIENT OUTCOME.

  Patient problems: Extubate

  MAUDE report 7176924 ↗

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-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-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-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-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-1465-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended
• 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-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-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-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-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
• 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-1478-2010 · Apr 13, 2010 · Terminated
  Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper
• 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-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

…and 8 more.