Shiley 8LPC-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20884522031988), received between Sep 19, 2018 and Sep 30, 2020 — classified as 9 injuries, 8 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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD ISSUES INFLATING THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10605427 ↗
• MalfunctionSep 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD ISSUES INFLATING THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10605414 ↗
• InjurySep 9, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE BALLOONS COULD NOT HOLD AIR ONCE INFLATED. IT WAS REPORTED THAT RE-INTUBATION WAS DONE WITH THE 3RD TUBE WITH NO PROBLEM.

  Patient problems: Extubate

  MAUDE report 8978191 ↗
• MalfunctionSep 9, 2019Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE BALLOONS COULD NOT HOLD AIR ONCE INFLATED. IT WAS REPORTED THAT RE-INTUBATION WAS DONE WITH THE 3RD TUBE WITH NO PROBLEM.

  Patient problems: Extubate

  MAUDE report 8975866 ↗
• MalfunctionAug 28, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE.

  Patient problems: No Information

  MAUDE report 8942299 ↗
• MalfunctionAug 28, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE.

  Patient problems: No Information

  MAUDE report 8942283 ↗
• InjuryAug 28, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE.

  Patient problems: Extubate; No Information

  MAUDE report 8942278 ↗
• MalfunctionAug 28, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE.

  Patient problems: No Information

  MAUDE report 8942276 ↗
• MalfunctionAug 28, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE.

  Patient problems: No Information

  MAUDE report 8942253 ↗
• MalfunctionAug 20, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD INFLATION/DEFLATION ISSUE. IT WAS REPORTED THAT AFTER DECANNULATION OF THE TRACHEOSTOMY TUBE, THE CUFF MAINTAINED ITS PRESSURE FOR 3 DAYS INDICATING IT WAS NOT LEAKING. IT WAS ALREADY REMOVED FROM PATIENT AND THERE HAD BEEN A RUN OF THE CUFF'S LEAKING LATELY. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 8910292 ↗
• InjuryAug 5, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, A VENTILATED PATIENT HAD AN EARLY TRACHEOSTOMY CHANGE DUE TO PERSISTENT CUFF LEAKED.

  Patient problems: Extubate

  MAUDE report 8861288 ↗
• InjurySep 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD CUFF INFLATION/DEFLATION ISSUE FOR SIZE 8 TUBE. THE CUSTOMER ALSO REPORTED THAT THE TRACHEOSTOMY TUBE WAS TESTED PRIOR TO BE BLOWING THE CUFF TO 15 CMH20 AND CHECKED WITH A PRESSURE GAUGE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS REINTUBATED AND TRANSFERRED TO ANOTHER HOSPITAL.

  Patient problems: Extubate

  MAUDE report 7889608 ↗
• InjurySep 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD CUFF INFLATION/DEFLATION ISSUE FOR SIZE 8 TUBE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS REINTUBATED. THE CUSTOMER ALSO REPORTED THAT THE TRACHEOSTOMY TUBE WAS TESTED PRIOR TO BE BLOWING THE CUFF TO 15 CMH20 AND CHECKED WITH A PRESSURE GAUGE. IT WAS ALSO NOTED THAT THE PATIENT IS CURRENTLY USING UNCUFFED TRACHEOSTOMY TUBE AND REMAINS IN THE HOSPITAL.

  Patient problems: Extubate

  MAUDE report 7889577 ↗
• InjurySep 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD CUFF INFLATION/DEFLATION ISSUE FOR SIZE 8 TUBE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS REINTUBATED. THE CUSTOMER INDICATED THAT THE TRACHEOSTOMY TUBE WAS TESTED PRIOR TO BE BLOWING THE CUFF TO 15 CMH20 AND CHECKED WITH A PRESSURE GAUGE. THE PATIENT WAS NOTED TO BE STILL IN THE HOSPITAL.

  Patient problems: Extubate

  MAUDE report 7889541 ↗
• InjurySep 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD CUFF INFLATION/DEFLATION ISSUE FOR SIZE 8 TUBE. THE CUSTOMER ALSO REPORTED THAT THE TRACHEOSTOMY TUBE WAS TESTED PRIOR TO BE BLOWING THE CUFF TO 15 CMH20 AND CHECKED WITH A PRESSURE GAUGE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS REINTUBATED AND DISCHARGED HOME.

  Patient problems: Extubate

  MAUDE report 7889380 ↗
• InjurySep 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD CUFF INFLATION/DEFLATION ISSUE FOR SIZE 8 TUBE. THE CUSTOMER REPORTED THAT THE TRACHEOSTOMY TUBE WAS TESTED PRIOR TO BE BLOWING THE CUFF TO 15 CMH20 AND CHECKED WITH A PRESSURE GAUGE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT WAS REINTUBATED. IT WAS INDICATED THAT THE PATIENT REMAINED IN (B)(6) ICU((B)(6), INTENSIVE CARE UNIT) AND THE TRACHEOSTOMY TUBE WAS CHANGED IN SIZE 7XL DUE TO ONGOING CUFF LEAK WITH THE SIZE 8.

  Patient problems: Extubate

  MAUDE report 7889355 ↗
• InjurySep 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE HAD CUFF INFLATION/DEFLATION ISSUE FOR SIZE 8 TUBE. THE CUSTOMER ALSO REPORTED THAT THE TRACHEOSTOMY TUBE WAS TESTED PRIOR TO BE BLOWING THE CUFF TO 15 CMH 20 AND CHECKED WITH A PRESSURE GAUGE. IT WAS ALSO INDICATED THAT THE PATIENT WAS REINTUBATED. THE PATIENT REMAINS IN THE HOSPITAL AND IS CURRENTLY USING 6 UNCUFFED TRACHEOSTOMY TUBE.

  Patient problems: Extubate

  MAUDE report 7889322 ↗

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

…and 8 more.