Shiley 4.0PDCRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 20884522029107), received between Aug 29, 2017 and Aug 22, 2024 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE TRACHEOSTOMY TUBE'S CUFF PRESSURE DROPPED IMMEDIATELY. THE TRACH WAS REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 20033543 ↗
• MalfunctionOct 20, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, A BREAKAGE WAS FOUND IN THE PILOT LINE OF THE TRACHEOSTOMY TUBE. REPLACEMENT OF THE TUBE WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 17977825 ↗
• MalfunctionDec 1, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, AT HOME DURING USE, THE PRODUCT WAS TESTED PRIOR TO USE. THE PATIENT KEEPS HAVING ISSUES WITH THE PILOT BALLOON. IT HAS BEEN BREAKING OFF AND SUBSEQUENTLY CUFF NOT HOLDING AIR. THE EVENT REQUIRED A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 15897948 ↗
• MalfunctionMar 2, 2022Use of Device Problem; Defective Component; Use of Device Problem; Defective Component

  ACCORDING TO THE REPORTER, DURING PRE-USE INSPECTION, THE CUFF OF THE DEVICE WAS EXTREMELY BULKY COMPARED TO THE SAME DEVICE WHEN DEGASSED. THE DEVICE WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652836 ↗
• MalfunctionFeb 1, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417685 ↗
• InjuryNov 11, 2021Mechanical Problem; Mechanical Problem

  ACCORDING TO THE REPORTER, AT THE TIME OF CHANGING, THE DEVICE WAS FOUND DEFLATED AND BEGINS TO BLEED SO THE NEW CANNULA CANNOT BE PLACED AND OPTED FOR A SMALLER NUMBER. THE PATIENT HAD A PROFUSE BLEEDING AND CONTROLLED WITH COLD SERUM. THE NEXT DAY THE PATIENT WAS TAKEN FOR A TRACHEOSTOMY THROUGH THE BRONCHOPULMONARY WARD UNDER GENERAL ANESTHESIA AND HAD SURGICAL TRACHEOSTOMY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12796834 ↗
• InjurySep 7, 2021Disconnection; Disconnection

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A FLANGE-CANNULA TUBE DISCONNECTION, WHICH GENERATED A FOREIGN BODY IN THE TRACHEAL AREA OF THE PATIENT. WHEN THE CANNULA RUPTURED, PART OF IT REMAINED IN THE PATIENT'S TRACHEAL CANAL. THE DEVICE WAS EXPLANTED COMPLETELY, AND THE CANNULA WAS REPLACED.

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

  MAUDE report 12437039 ↗
• InjuryAug 17, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, 7 DAYS AFTER THE START OF USE, LEAKAGE OF VENTILATOR OCCURRED, THEY CONCERNED ABOUT THE CUFF BREAKAGE, AND REPLACED THE PRODUCT. REINTUBATION WAS REQUIRED TO THE PATIENT.

  Patient problems: Extubate; Unintended Extubation

  MAUDE report 10412554 ↗
• MalfunctionJul 2, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING PRE-USE INSPECTION, THERE WAS A CUFF LEAKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10226257 ↗
• MalfunctionJul 11, 2019Defective Device; Defective Device

  ACCORDING TO THE REPORTER, THE OBTURATOR IS STIFF AND HARD TO COME OFF WHEN CHECKING AFTER OPENING THE PRODUCT. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8781605 ↗
• MalfunctionJun 16, 2019Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, PRIOR TO USE, IT WAS DIFFICULT TO PULL OUT AND INSERT THE OBTURATOR BECAUSE ITS MOVEMENT WAS NOT SMOOTH. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8702631 ↗
• MalfunctionMay 16, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PREOPERATIVELY, THE AIR COULD NOT GET IN AND THE CUFF GOT DEFLATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8616665 ↗
• MalfunctionApr 18, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE CUFF LEAKED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 8529451 ↗
• InjuryApr 18, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THERE WAS A LEAKAGE IN THE UNIT. IT WAS REPORTED THAT THEY REPLACED THE TRACHEOSTOMY TUBE. WHEN THEY IMMERSED THE TUBE IN WATER, WATER BUBBLES CAME OUT OF THE INFLATION LINE.

  Patient problems: Extubate

  MAUDE report 8526980 ↗
• InjuryJul 26, 2018Contamination of Device Ingredient or Reagent; Device Contamination with Chemical or Other Material; Contamination of Device Ingredient or Reagent

  ACCORDING TO THE REPORTER, A RUST OF MOLD WAS FOUND ON THE PRODUCT STRING. IT WAS INDICATED THAT A RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate; No Code Available; No Patient Involvement

  MAUDE report 7723668 ↗
• InjuryJun 5, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, WHILE IN USE ON A PATIENT, AIR LEAK WAS OBSERVED UPON THE START OF USE ON PATIENT. CUSTOMER INDICATED THAT THERE WAS RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 7569542 ↗
• InjurySep 18, 2017Air Leak; Air Leak

  MEDTRONIC RECEIVED A REPORT THAT DURING PATIENT USE THE PILOT BALLOON DEFLATED. THE CUSTOMER REPORTED RECANNULATION WITH A REPLACEMENT TUBE WAS REQUIRED AND THERE WAS NO PATIENT HARM.

  Patient problems: Extubate

  MAUDE report 6873970 ↗
• MalfunctionAug 29, 2017Obstruction of Flow; Obstruction of Flow

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, THE OBTURATOR WAS DIFFICULT TO INSERT THROUGH THE TUBE. THE TUBE WAS EVENTUALLY INSERTED. THE CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6828289 ↗

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-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
• 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-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-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