Shiley 10FENRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 60884522006984), received between Jul 23, 2020 and Jan 19, 2023 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PRODUCT WAS TESTED PRIOR TO USE WITH 18 A 22 MMHG THAT WAS DETERMINED BY A "CUFFOMETER". DURING USE, THE PILOT BALLOON HAD AN INFLATION/DEFLATION ISSUE. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS.

  Patient problems: Respiratory Insufficiency

  MAUDE report 16203553 ↗
• MalfunctionDec 12, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE PILOT BALLOON COULD NOT REMAINED INFLATED. THERE A REQUIRED TUBE REPLACEMENT.

  Patient problems: Unintended Extubation

  MAUDE report 15960743 ↗
• MalfunctionAug 24, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. IN ADDITION THE PROBLEM WAS NOTICED DIRECTLY WHEN FILLING THE CUFFS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10446506 ↗
• MalfunctionAug 24, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. IN ADDITION THE PROBLEM WAS NOTICED DIRECTLY WHEN FILLING THE CUFFS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10446324 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10317600 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10317253 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10315555 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10313383 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10312633 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10312591 ↗
• MalfunctionJul 23, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10312324 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 8 more.