Shiley 6SCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20884522031216), received between Jan 31, 2020 and Jun 17, 2022 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A HOLE CREATING A LEAK WHERE IT BALLOONS UP ON THE TRACH. RECANNULATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 14738643 ↗
• MalfunctionMay 25, 2022Defective Component; Gas/Air Leak; Defective Component; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE LEAKED WHERE IT BALLOONS UP ON THE TRACH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 14496681 ↗
• MalfunctionMay 25, 2022Gas/Air Leak; Insufficient Device Problem Information; Gas/Air Leak; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE LEAKED WHERE IT BALLOONS UP ON THE TRACH. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 14496657 ↗
• MalfunctionMay 6, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WAS BROKEN. IT WAS INDICATED THAT THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 11783581 ↗
• MalfunctionNov 3, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD NO PRESSURE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777084 ↗
• MalfunctionNov 3, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER THE DEVICE HAD CUFF WITHOUT PRESSURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777045 ↗
• InjuryJun 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT THEY HAVE NOTICE THAT THE CUFF HAS NO PRESSURE. EXCHANGE PERFORMED IN A HOSPITAL UNIT, PATIENT IS IN HOME CARE AND USING A TRILOGY MODEL VENTILATOR.

  Patient problems: Extubate; Unintended Extubation

  MAUDE report 10183345 ↗
• InjuryJun 2, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WAS EMPTY. IT WAS INDICATED THAT THE NEED TO CHANGE THE TRACHEOSTOMY CANNULA WAS CONFIRMED BY THE ATTENDING PHYSICIAN.

  Patient problems: Extubate

  MAUDE report 10108488 ↗
• InjuryJan 31, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER 13 DAYS OF USE, THE DEVICE'S CUFF WAS SPONTANEOUSLY DEFLATING, CANNULA DOES NOT REMAIN INFLATED AND THERE WAS A LEAKED ON THE INPUT CONNECTOR . PATIENT'S RESPIRATORY RATE OF 16 RPM WAS INCREASED TO 35 TO 45 RPM THAT CAUSED DISCOMFORT DUE TO LOSS OF AIR AND IT WAS NECESSARY TO CHANGED THE TUBE IMMEDIATELY. PATIENT WAS REINTUBATED.

  Patient problems: Extubate; Injury

  MAUDE report 9653534 ↗
• InjuryJan 31, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE BALLOON KEEP DEFLATING. SOME TESTS WERE DONE AND IT WAS FOUND OUT THAT THE PROBLEM WAS OCCURRING WHEN THE INNER CANNULA CAME OUT WHERE IT MAKE A SMOOTH CURVE. WHEN INVERTING THE CURVE TO THE OPPOSITE SIDE, THE CUFF REMAINED FOR MORE THAN AN INFLATED TOP AND WHEN IT RETURNED TO THE CORRECT PLACE, IT EMPTIED IMMEDIATELY. THE PATIENT HAD A CHANGE IN RESPIRATORY RATE AND WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 9653475 ↗

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-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-1462-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• 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-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-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-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-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-1473-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, C
• Z-1463-2010 · Apr 13, 2010 · Terminated
  Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended f
• 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-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-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-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-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

…and 8 more.