Shiley 5.0PLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884522029039), received between May 2, 2018 and Jun 30, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS TESTED PRIOR TO USE WITHOUT ANY PROBLEM, BUT THE INFLATION LINE HAD A LEAKAGE IN THE MIDWAY. EVEN THE AIR WAS INTRODUCED, THE PILOT BALLOON AND CUFF DID NOT INFLATE AND THE AIR LEAKED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation

  MAUDE report 14879819 ↗
• InjuryFeb 20, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF DID NOT INFLATE. RE-INTUBATION WAS REQUIRED.

  Patient problems: Extubate; No Consequences Or Impact To Patient

  MAUDE report 9731914 ↗
• InjuryJan 30, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING TUBE EXCHANGE, LEAKAGE OCCURRED. IT WAS REPORTED THAT AFTER THEY CHECKED THE CUFF PRESSURE AS USUAL, THE SITUATION WAS STILL THE SAME. WHEN THE TUBE WAS REPLACED WITH A NEW TUBE, THE PROBLEM WAS SOLVED. WHEN THE CUFF OF THE DEFECTIVE PRODUCT WAS CHECKED, IT WAS FOUND TO RUCK UP EASIER COMPARED TO THE USUAL.

  Patient problems: Extubate

  MAUDE report 9647853 ↗
• InjuryMay 2, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, AFTER THE PATIENT WAS INTUBATED, THE CUFF WAS NOT INFLATED.

  Patient problems: Extubate

  MAUDE report 7481937 ↗

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-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-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
• 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-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-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-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