Shiley 10LPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 60884522007110), received between Aug 7, 2017 and Aug 30, 2021 — classified as 3 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 30, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE WAS DAMAGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12385967 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF WAS PUNCTURED, RESULTING IN RECANNULATION THE ISSUE DID NOT CAUSE HARM. THE PATIENT WAS REPORTED TO HAVE DIED DUE TO COVID-19 RELATED COMPLICATIONS, UNRELATED TO THE EVENT AND/OR DEVICE.

  Patient problems: Death

  MAUDE report 10655953 ↗
• InjuryMar 26, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE. CANNULA REPLACEMENT WAS NECESSARY.

  Patient problems: Extubate

  MAUDE report 9882889 ↗
• InjurySep 19, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE PILOT BALLOON HAD A CUFF INFLATION/DEFLATION ISSUE. THE DEVICE DOES NOT MAINTAIN THE PRESSURE PLACED CAUSING TOO MUCH EXHAUST. IT WAS INDICATED THAT THEY MADE AN URGENT CANNULA EXCHANGE.

  Patient problems: Extubate

  MAUDE report 9090686 ↗
• MalfunctionAug 28, 2019Use of Device Problem; Use of Device Problem

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8942891 ↗
• MalfunctionOct 10, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD CUFF LEAKAGE. PATIENT OUTCOME WAS ASKED BUT UNKNOWN.

  Patient problems: No Information

  MAUDE report 7952253 ↗
• InjuryJan 3, 2018Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN OXYGEN LEAKAGE AND THE CANNULA WAS DISCONNECTED. THE PATIENT WAS IN HOME CARE AND NEEDED TO BE HOSPITALIZED. THERE WAS NO PATIENT INJURY REPORTED IN THIS EVENT.

  Patient problems: Extubate

  MAUDE report 7160906 ↗
• MalfunctionOct 27, 2017Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING AN ALLEGED DIMENSIONAL ISSUE. ACCORDING TO THE REPORTER, IT WAS DIFFICULT TO SEPARATE THE INNER CANNULA FROM THE OUTER CANNULA AS IT WAS DIFFICULT TO TWIST. IT WAS ALLEGED THAT THERE WAS MORE SPACE BETWEEN THE CANNULAS THAN EXPECTED. IT WAS REPORTED THAT THE CANNULAS WERE NOT USED ON ANY PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6985078 ↗
• MalfunctionOct 27, 2017Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING AN ALLEGED DIMENSIONAL ISSUE. ACCORDING TO THE REPORTER, IT WAS DIFFICULT TO SEPARATE THE INNER CANNULA FROM THE OUTER CANNULA AS IT WAS DIFFICULT TO TWIST. IT WAS ALLEGED THAT THERE WAS MORE SPACE BETWEEN THE CANNULAS THAN EXPECTED. IT WAS REPORTED THAT THE CANNULAS WERE NOT USED ON ANY PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6985041 ↗
• MalfunctionOct 27, 2017Material Integrity Problem; Material Integrity Problem

  MEDTRONIC RECEIVED A COMMUNICATION REGARDING AN ALLEGED DIMENSIONAL ISSUE. ACCORDING TO THE REPORTER, IT WAS DIFFICULT TO SEPARATE THE INNER CANNULA FROM THE OUTER CANNULA AS IT WAS DIFFICULT TO TWIST. IT WAS ALLEGED THAT THERE WAS MORE SPACE BETWEEN THE CANNULAS THAN EXPECTED. IT WAS REPORTED THAT THE CANNULAS WERE NOT USED ON ANY PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6985039 ↗
• MalfunctionAug 7, 2017Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT THE UNIT WAS HAVING INFLATION/ DEFLATION ISSUE. THERE WAS NO ALLEGATION OF PATIENT HARM OR INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6771656 ↗

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

…and 8 more.