Shiley 5.0PDCRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 20884522029121), received between Aug 8, 2017 and Aug 22, 2023 — classified as 7 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INFLATION LINE OF THE TRACH CANNULA WAS DAMAGED, WHEREIN COMPLETELY CAME OFF. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17599327 ↗
• MalfunctionMay 30, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE WAS DAMAGE DURING PROCEDURE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17020987 ↗
• MalfunctionApr 27, 2021Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE WAS NOT ABLE TO INFLATE THE CUFF COMPLETELY. THERE WAS NO PATIENT INJURY/HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731590 ↗
• MalfunctionOct 22, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE CUFF DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

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

  MAUDE report 10718106 ↗
• MalfunctionJun 12, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN ABNORMALITY IN THE CUFF AND THE USE WAS DISCONTINUED. THERE WAS NO PATIENT INJURY/HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10148393 ↗
• InjuryJun 9, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, AFTER REPLACING THE TUBE, THE DEVICE'S CUFF WAS TRIED TO INFLATED, BUT IT FAILED. REPLACEMENT WAS PERFORMED. UPON CHECKING ON THE CUFF, A HOLE WAS FOUND TO BE OPENED. INTUBATION REQUIRED

  Patient problems: Extubate

  MAUDE report 10135463 ↗
• MalfunctionMay 14, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE WAS DEFECTIVE. WHEN EXCHANGING TRACHEOSTOMY TUBE, CUFF CHECK WAS PERFORMED. THE CUFF WAS MORE SQUARE AND BULKIER THAN USUAL. IT BECAME A RESISTANCE WHEN IT WAS INSERTED INTO THE TRACHEOSTOMY HOLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10057624 ↗
• MalfunctionMar 31, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AFTER OPENING THE NEW PRODUCT, WHEN PERFORMING CUFF CHECK, AIR GOT OUT IMMEDIATELY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9908681 ↗
• InjuryMar 3, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE¿S CUFF HAD AN AIR LEAKAGE. A SHARP SCRATCH WAS FOUND DURING INSPECTION. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 9780612 ↗
• MalfunctionFeb 16, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE UNIT WAS TOO FLIMSY. THE CUSTOMER STATED THEY ARE HAVING TROUBLE REPLACING THE TUBE DURING ROUTINE TRACH CHANGES. SIMILAR PROBLEM AS THE OTHER PATIENT. BOTH PATIENTS ARE SPECIAL NEEDS, YOUNG TEENAGE BOYS WITH A ROBUST COUGH REFLEX. DURING TRACH CHANGES THEY REQUIRE A LOT OF FORCE TO PASS THE TUBE THROUGH THE STOMA. THEY FOUND THAT THE ENTIRE UNIT BENDS IN HALF WHEN TRYING TO PASS IT THROUGH THE STOMA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9715250 ↗
• InjuryFeb 5, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD AN AIR LEAK. IT WAS INDICATED THAT REPLACEMENT OF TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9670611 ↗
• MalfunctionOct 17, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, THE DEVICE'S CUFF WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9203580 ↗
• MalfunctionMay 10, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, AN AIR LEAKAGE WAS FOUND DURING CUFF CHECK. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8600301 ↗
• MalfunctionMay 6, 2019Material Puncture/Hole; Material Puncture/Hole

  ACCORDING TO THE REPORTER, DURING USE, IT WAS FOUND THAT THE DEVICE'S CUFF DEFLATED AND POINTED OUT THAT A HOLE WAS OPEN. REPLACEMENT OF THE TUBE WAS NOT REQUIRED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8581124 ↗
• MalfunctionFeb 13, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF DID NOT INFLATE. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8337003 ↗
• MalfunctionOct 29, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  ACCORDING TO THE REPORTER, THE CUFF DID NOT INFLATE AND HAD A LEAKAGE. IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8015941 ↗
• MalfunctionSep 17, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE ON A PATIENT, THE DEVICE CUFF WAS NOT INFLATED WHILE CHECKING. THE CUSTOMER STATED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7881245 ↗
• InjuryJun 15, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE ON PATIENT, THE DEVICE HAD AN AIR LEAKED FROM THE CUFF AND THE PILOT BALLOON WAS EASILY DEFLATED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED WITH NEW ONE BUT THE ISSUE WAS DUPLICATED. THE PATIENT WAS REQUIRED RE-CANNULATION.

  Patient problems: Extubate

  MAUDE report 7606451 ↗
• InjuryJun 15, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE ON PATIENT, THE DEVICE HAD AN AIR LEAKED FROM THE CUFF AND THE PILOT BALLOON WAS EASILY DEFLATED. IT WAS REPORTED THAT THE DEVICE WAS REPLACED WITH NEW ONE BUT THE ISSUE WAS DUPLICATED. THE PATIENT WAS REQUIRED RE-CANNULATION.

  Patient problems: Extubate

  MAUDE report 7605495 ↗
• InjuryJan 18, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, IN 10 DAYS OF PATIENT USE AN AIR LEAK OCCURRED BETWEEN THE INFLATION LINE AND THE TRACH TUBE CONNECTION. THE TUBE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 7203737 ↗
• InjurySep 29, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT DURING PATIENT USE THE TUBE'S CUFF LEAKED. THE TUBE WAS REMOVED AND REPLACED. THE CUSTOMER REPORTED THERE WAS NO PATIENT HARM.

  Patient problems: Extubate

  MAUDE report 6904925 ↗
• MalfunctionAug 8, 2017Air Leak; Air Leak

  MEDTRONIC RECEIVED A COMMUNICATION THAT WHILE EXCHANGING THE CANNULA, A LEAK WAS FOUND. THE CUSTOMER INDICATED THAT MEDICAL INTERVENTION WAS NOT REQUIRED DUE TO THE EVENT.

  Patient problems: No Information

  MAUDE report 6773398 ↗

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-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-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-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-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-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-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-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