Shiley 8LPCRecalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 60884522007141), received between Mar 22, 2017 and Oct 18, 2022 — classified as 16 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Inflation 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, POSTOPERATIVELY, THE PATIENT WAS ON HOME VENTILATION WHEN LEAKAGE FROM THE CUFF OCCURRED, AND FURTHER SOUND OF THE ALARM. THE PATIENT INITIALLY BOUGHT ANOTHER TUBE FOR THIS INCIDENT, BUT A SIMILAR ISSUE OCCURRED AGAIN. THERE WAS BLEEDING FROM THE WOUND AT THE TRACHEA SITE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15621497 ↗
• InjuryOct 18, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE PATIENT WAS ON HOME VENTILATION WHICH ALARMED DUE TO A CUFF LEAK. THE PATIENT HAD A TRACH FOR 7 YEARS PRIOR TO THE EVENT. THERE WAS BLEEDING AT THE TRACH SITE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury; Wound Dehiscence

  MAUDE report 15621483 ↗
• InjurySep 14, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CUFF WAS PARTLY BROKEN (LITERALLY DETACHED) THAT CAUSED BAD VENTILATION FOR SOME MINUTES. THE UNIT WAS REPLACED DUE TO AIR LOSS IN THE VENTILATION OF THE PATIENT, WITHOUT APPARENT JUSTIFICATION, AND WITH DECREASED OXYGEN SATURATION (MILD HYPOXEMIA).

  Patient problems: Unintended Extubation

  MAUDE report 12470031 ↗
• InjurySep 14, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE CUFF WAS PARTLY BROKEN (LITERALLY DETACHED) THAT CAUSED BAD VENTILATION FOR SOME MINUTES. THE UNIT WAS REPLACED DUE TO AIR LOSS IN THE VENTILATION OF THE PATIENT, WITHOUT APPARENT JUSTIFICATION, AND WITH DECREASED OXYGEN SATURATION (MILD HYPOXEMIA).

  Patient problems: Unintended Extubation

  MAUDE report 12467734 ↗
• MalfunctionJan 8, 2021Material Separation; Material Separation

  ACCORDING TO THE REPORTER, THE UNIT HOLDER HAD BREAKAGE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 11138689 ↗
• MalfunctionJan 7, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PRODUCT HAD A CUFF INFLATION/DEFLATION ISSUE DURING A PROCEDURE. THE TUBE WAS REPLACED WITHOUT PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 11131645 ↗
• MalfunctionNov 9, 2020Material Separation; Material Separation

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE MIDDLE OF THE CUFF WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10812481 ↗
• InjuryJun 17, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD CUFF INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 10162597 ↗
• InjuryDec 26, 2019Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE HAD CRACKS ALONG THE SEEM OF OUTER CANNULA AND SEVERAL TIMES HAD TO HAVE THE TRACH CHANGED BEFORE BECAUSE THE INNER CANNULA WILL PULL OUT BY ITSELF CAUSING TO LOOSE THEM ON THE FLOOR. THIS HAPPENED THREE TIMES IN THE PAST 4 MONTHS.

  Patient problems: Extubate

  MAUDE report 9521214 ↗
• InjuryDec 20, 2019Crack; Crack

  ACCORDING TO THE REPORTER, THE DEVICE HAD CRACKS ALONG THE SEEM OF OUTER CANNULA AND SEVERAL TIMES HAD TO HAVE THE TRACH CHANGED BEFORE BECAUSE THE INNER CANNULA WILL PULL OUT BY ITSELF CAUSING TO LOOSE THEM ON THE FLOOR. THIS HAPPENED THREE TIMES IN THE PAST 4 MONTHS.

  Patient problems: Extubate

  MAUDE report 9501718 ↗
• InjuryDec 19, 2019Crack; Crack

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE¿S CONNECTOR WAS CRACKED AND THE TRACHEOSTOMY WAS CHANGED SEVERAL TIMES BECAUSE THE INNER CANNULA FALLS OUT AND DROPPED ON THE FLOOR THAT CAUSED THE PATIENT STRUGGLING TO BREATH WHILE THE CAREGIVER WASHING THE CANNULA.

  Patient problems: Extubate

  MAUDE report 9499506 ↗
• InjurySep 27, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS LEAKAGE AT THE JUNCTION BETWEEN THE BALLOON AND THE TRACHEOTOMY TUBE. THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 9128564 ↗
• InjurySep 9, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT CUFF HAD INFLATION/DEFLATION ISSUE. IT WAS INDICATED THAT ANOTHER TRACHEOSTOMY CANNULA WAS USED.

  Patient problems: Extubate

  MAUDE report 8978132 ↗
• InjuryJul 29, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD INFLATION/DEFLATION ISSUE. AFTER BLOWING THE BALLOON, IT WAS SEEN THAT THE BALLOON WAS STUCK. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 8836749 ↗
• InjuryJun 13, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, THE DEVICE STARTED LEAKING TWO WEEKS AFTER INSERTION AND THE AIR COULD NOT HOLD. IT WAS REPORTED THAT THE DEVICE WAS REPLACED.

  Patient problems: Extubate

  MAUDE report 8696058 ↗
• MalfunctionFeb 8, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE CUFF HAD A LEAKAGE AROUND THE CURVE AREA IN THE TUBE. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 8319943 ↗
• MalfunctionSep 24, 2018Patient-Device Incompatibility

  TWO PRESSURE INJURIES DEVELOPED UNDER THE FACEPLATE OF THE TRACHEOSTOMY.

  Patient problems: Injury

  MAUDE report 7901399 ↗
• InjurySep 19, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBES 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. IT WAS ALSO INDICATED THAT THE PATIENT WAS REINTUBATED AND IS CURRENTLY USING SIZE 6 UNCUFFED TRACHEOSTOMY TUBE WHEN DISCHARGED TO REHAB.

  Patient problems: Extubate

  MAUDE report 7889237 ↗
• InjuryJul 3, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD AIR LEAK AROUND THE CUFF. THE CUSTOMER INDICATED THAT THE PATIENT WAS RE-CANNULATED.

  Patient problems: Extubate

  MAUDE report 7658816 ↗
• MalfunctionMar 30, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE BALLOON OF THE DEVICE WERE PIERCED. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7386731 ↗
• MalfunctionMar 30, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE BALLOONS OF THE DEVICES WERE PIERCED. THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7386667 ↗
• MalfunctionFeb 15, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, A CUFF BREAKAGE OCCURRED. THE CUFF WAS RELEASED FROM THE TRACHEAL CANNULA. THERE WAS NO INJURY AND NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7273127 ↗
• MalfunctionFeb 15, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE, A CUFF BREAKAGE OCCURRED. THE CUFF WAS RELEASED FROM THE TRACHEAL CANNULA. THERE WAS NO INJURY AND NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7273074 ↗
• InjuryDec 8, 2017Crack; Crack

  ACCORDING TO THE REPORTER THERE WAS A CRACK IN THE DEVICE'S INNER AND OUTER CANNULA. THE REPORTER STATED THE PATIENT STATUS WAS ASKED BUT UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7101941 ↗
• InjuryOct 11, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT REGARDING CUFF BREAKAGE. ACCORDING TO THE REPORTER, THE UNIT HAD A CUFF RUPTURE AND LOST PRESSURE. CUSTOMER REPORTED THAT A REPLACEMENT OF THE DEVICE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 6942877 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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.