Shiley 5.5PDCRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 20884522029138), received between Oct 4, 2017 and May 26, 2023 — classified as 9 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF HAD AN INFLATION OR DEFLATION ISSUE DURING USE. THE TUBE WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 17010769 ↗
• MalfunctionMay 10, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE TRACH'S CUFF HAD AN INFLATION OR DEFLATION ISSUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904080 ↗
• MalfunctionFeb 17, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A LEAK ON THE DEVICE DURING USE. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 16399971 ↗
• MalfunctionFeb 16, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THERE WAS A LEAK ON THE DEVICE DURING USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16391614 ↗
• MalfunctionDec 28, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE NEW DEVICE HAD AN AIR LEAKAGE FROM THE CUFF. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 16061207 ↗
• MalfunctionJun 10, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE INFLATION LINE HAD BEEN CUT. THE PHYSICIAN IMMEDIATELY REPLACED THE TUBE AND THE PATIENT DID NOT EXPERIENCE ANY HEALTH DAMAGE.

  Patient problems: Unintended Extubation

  MAUDE report 14657398 ↗
• MalfunctionMay 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAS WRINKLES IN THE CUFF AND COULD NOT BE REMOVED. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 14498451 ↗
• MalfunctionMay 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAS WRINKLES IN THE CUFF AND COULD NOT BE REMOVED. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 14498385 ↗
• MalfunctionMay 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE HAS WRINKLES IN THE CUFF AND COULD NOT BE REMOVED. THERE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 14498313 ↗
• MalfunctionMay 5, 2022Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, DURING TESTING, THE CUFF OF THE DEVICE DID NOT INFLATE AND FOUND WITH WRINKLES. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14288350 ↗
• MalfunctionApr 13, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S WRINKLES WOULD NOT DISAPPEAR. ANOTHER PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104397 ↗
• MalfunctionApr 13, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S WRINKLES WOULD NOT DISAPPEAR. ANOTHER PRODUCT WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14104351 ↗
• MalfunctionApr 13, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT STRETCH. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 14104253 ↗
• MalfunctionApr 13, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WOULD NOT STRETCH. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 14104217 ↗
• MalfunctionMar 29, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE AIR COULD NOT BE REMOVED USING A SYRINGE WHEN THE TUBE WAS REPLACED BY THE USE OF AN AUTOMATIC CALF PRESSURE CONTROLLER. ONE VALVE (VALVE) OF THE PILOT BALLOON FELL OUT. WHEN IT WAS RETURNED, AIR WAS ABLE TO REMOVED USING A SYRINGE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 13940961 ↗
• MalfunctionMar 19, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD WRINKLES AFTER HARD PAPER WAS WRAPPED AROUND AND AIR WAS INJECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827525 ↗
• MalfunctionFeb 25, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF HAD WRINKLES AFTER HARD PAPER WAS WRAPPED AROUND . THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13604183 ↗
• MalfunctionJan 28, 2022Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF HAD WRINKLES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13386573 ↗
• MalfunctionDec 10, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF HAD AN INFLATION/DEFLATION ISSUE. THE "WRINKLE" DID NOT EXTEND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975318 ↗
• MalfunctionOct 26, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF OF THE DEVICE WAS DEEPLY WRINKLED EVEN IT WAS INFLATED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697485 ↗
• MalfunctionOct 6, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE BROKE OFF. THERE WAS NO PATIENT INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12584000 ↗
• MalfunctionSep 30, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE AND THE CUFF HAD TOO MUCH WRINKLES ON IT. THE RE WAS NO PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 12556154 ↗
• MalfunctionAug 4, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER TWO WEEKS OF USE, THE CUFF PRESSURE OF THE DEVICE HAD DECREASED. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information; Unintended Extubation

  MAUDE report 12274170 ↗
• MalfunctionJul 8, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING EXTUBATION, THE DEVICE WAS REMOVED AND THE OPENING AT THE TIP OF CUFF WAS FOUND TO BE DEFORMED (ALTHOUGH IT HAD BEEN CONTINUOUSLY REPLACED, THIS WAS THE FIRST TIME). THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Extubation

  MAUDE report 12140249 ↗
• MalfunctionJun 30, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE TUBE COULD NOT BE INSERTED. A NEW DEVICE WAS USED AND RECANNULATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 12093984 ↗

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-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-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-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-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-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-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-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