Shiley 5.5PLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 20884522029046), received between Apr 5, 2017 and Mar 16, 2023 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (5 reports).

8 other recalls cover devices cleared under the same FDA submission (K955680); 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE HAD A SIGNIFICANT AIR LEAK DURING USE. THE PATIENT REQUIRED REPLACEMENT OF THE DEVICE.

  Patient problems: Unintended Extubation

  MAUDE report 16553258 ↗
• MalfunctionJul 21, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF WAS PRE-TESTED AND THE CUFF INFLATED/DEFLATED. LEAKAGE WAS FOUND IN THE PILOT BALLOON. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15075798 ↗
• InjuryJun 15, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S PILOT BALLOON CAME OFF WITHOUT RESISTANCE AS THE PATIENT CHANGED HIS/HER CLOTHES AT HOME, AND THE TUBE INSIDE GOT EXPOSED. AS SUCH, IT BECAME UNABLE TO MAINTAIN THE PRESSURE OF THE CUFF, THE PATIENT VISITED THE HOSPITAL FOR AN EMERGENCY AND WAS HOSPITALIZED TO CHANGE THE TRACHEOSTOMY TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 14695262 ↗
• MalfunctionDec 9, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE AIR CAME OUT OF THE CUFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12968374 ↗
• InjuryDec 14, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A LEAK-LIKE SOUND, SO IT WAS REQUESTED TO CHECK WHETHER THERE WAS A PINHOLE IN THE CUFF. THE PATIENT WAS RECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 11003828 ↗
• InjuryFeb 6, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, A CUFF CHECK WAS PERFORMED BEFORE REPLACING CANNULA. AFTER 3 HOURS OF REPLACEMENT, THERE WAS A CUFF LEAKAGE AND WAS REPLACED.

  Patient problems: Extubate

  MAUDE report 9676542 ↗
• InjuryJul 11, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE NURSE NOTED THAT THE PILOT BALLOON DEFLATED AND INJECTED AIR AS A SOLUTION. UPON CHECKING BY DAY SHIFT STAFF THE FOLLOWING DAY, IT WAS NOTED THAT SPO2 HAD DECREASED TO 45%, AND IT WAS FOUND THAT THE CUFF WAS DEFLATED. AFTER REPLACING THE CANNULA, THE ISSUE WAS RESOLVED.

  Patient problems: Extubate

  MAUDE report 8781565 ↗
• MalfunctionMay 14, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING CHECKING, THE CUFF DID NOT INFLATE. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7512240 ↗
• MalfunctionApr 5, 2017Material Deformation; Material Deformation

  MEDTRONIC RECEIVED A REPORT THAT A CUFF WAS MALFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6462717 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955680. One submission often covers many models, so check the product and lot details in each record.

• Z-1492-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Pediatric Tracheostomy Tube, 4.0 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
• Z-1498-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of up
• Z-1494-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Pediatric Tracheostomy Tube, 5.0 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
• Z-1499-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of up
• Z-1496-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.0 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of up
• Z-1493-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a
• Z-1497-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.5 PLC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of up
• Z-1495-2010 · Apr 13, 2010 · Terminated
  Shiley Cuffed Pediatric Tracheostomy Tube, 5.5 PDC, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper a