Shiley 6.5PLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 20884522029060), received between Aug 10, 2017 and Apr 15, 2024 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACHEOSTOMY TUBE'S CUFF PRESSURE WAS UNCONTROLLABLE DURING USE. THE TRACH TUBE WAS REMOVED AND REPLACED.

  Patient problems: Unintended Extubation

  MAUDE report 19105781 ↗
• MalfunctionFeb 2, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE PILOT BALLOON WOULD NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16284895 ↗
• MalfunctionJun 9, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE TRACH'S BALLOON (CUFF) SEAL LOSES AIR AFTER 1 OR 2 DAYS OF USE AND MUST BE REPLACED. THE PATIENT WAS ON VENTILATOR 12 HOURS, OVERNIGHT. THE CUFF WAS TESTED PRIOR TO USE. THE CUFF INFLATED BUT LOST PRESSURE.  IT WAS NOTED THAT THE CUFF WALLS FEEL THINNER. THE PATIENT'S AIRWAY ANATOMY WAS NOT UNUSUAL AND HAD BEEN USING THE SAME TRACH FOR 20 YEARS. THE TUBE WAS NOT LUBRICATED BEFORE INSERTION. THE TRACH TUBES WAS CLEANED WITH SOAP AND WATER. THERE WAS NO PHYSICAL/WATER DAMAGE.

  Patient problems: Unintended Extubation

  MAUDE report 14648940 ↗
• MalfunctionJun 9, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WOULD NOT HOLD AIR AND CUFF WALLS FELT THINNER. IT WORKED INITIALLY BUT AFTER 1 OR 2 DAYS THE CUFF NO LONGER HOLD THE AIR AND MUST BE REPLACED. PATIENT WAS RECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 14647142 ↗
• MalfunctionJun 9, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE CUFF WOULD NOT HOLD AIR AND CUFF WALLS FELT THINNER. IT WORKED INITIALLY BUT AFTER 1 OR 2 DAYS THE CUFF NO LONGER HOLD THE AIR AND MUST BE REPLACED. PATIENT WAS RECANNULATED.

  Patient problems: Unintended Extubation

  MAUDE report 14647019 ↗
• MalfunctionDec 6, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING THE CHECK OF THE CUFF, THE CUFF WOULD NOT INFLATE. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12933219 ↗
• MalfunctionJan 4, 2021Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE ANGLE OF THE CANNULA WAS DIFFERENT AND IT HURT THE PATIENT. RECANNULATION WAS REQUIRED.

  Patient problems: Unintended Extubation

  MAUDE report 11108710 ↗
• InjuryDec 1, 2020Defective Component; Defective Component

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S SHAPE AND CURVE WAS NOT USUAL. THE PATIENT REQUIRED RECANNULATION.

  Patient problems: Unintended Extubation

  MAUDE report 10927284 ↗
• MalfunctionOct 26, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, WHEN AIR WAS INJECTED TO THE DEVICE, THE CUFF WITHERED. AIR WAS INJECTED SEVERAL TIMES ABOUT EVERY 2 HOURS, BUT AIR WOULD COME OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10732915 ↗
• MalfunctionSep 30, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE UNIT CUFF DID NOT INFLATE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10609957 ↗
• MalfunctionJul 28, 2020Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD A SUCTION TUBE THAT COULD GET NOTHING THROUGH. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10331298 ↗
• InjuryOct 18, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, ONE HOUR AFTER THE START OF USING THE PRODUCT, THE DEVICE HAD AN AIR LEAK FROM THE CUFF. IT WAS REPORTED THAT RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED.

  Patient problems: Extubate

  MAUDE report 9206505 ↗
• MalfunctionJul 30, 2019Use of Device Problem; Use of Device Problem

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

  Patient problems: No Patient Involvement

  MAUDE report 8842806 ↗
• InjuryJun 14, 2019Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING HOSPITALIZATION, THE DEVICE HAD AN AIR LEAKAGE AND WAS NOTICED DUE TO AIR LEAKING SOUND AND THE PILOT BALLOON SEEMED IMMEDIATELY DEFLATED ALTHOUGH THERE WAS AN AIR INJECTED. THE CUSTOMER INDICATED THAT THERE WAS A REPLACEMENT OF THE TUBE DONE TO THE PATIENT.

  Patient problems: Extubate

  MAUDE report 8701186 ↗
• MalfunctionFeb 20, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE COULD NOT MAINTAIN FULL INFLATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Information

  MAUDE report 8354216 ↗
• MalfunctionFeb 20, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE COULD NOT MAINTAINED FULL INFLATION. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Information

  MAUDE report 8353732 ↗
• InjuryNov 27, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF COULD NOT HOLD AIR AND SHRUNK QUICKLY ALTHOUGH THE AIR WENT IN. IT WAS ALSO REPORTED THAT WHEN THE CUFF WAS DEGAS AND CONTINUOUSLY APPLY NEGATIVE PRESSURE, IT WAS INFLATED ADVERSELY. IT WAS INDICATED THAT THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 8107880 ↗
• InjuryJun 26, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS CHECKED BY CUFF PRESSURE GAUGE, THE AIR DID NOT ENTER THE CUFF. IT WAS REPORTED THAT AFTER EXTUBATION, IT WAS CONFIRMED THAT THE AIR ENTERED THE CUFF.

  Patient problems: Extubate

  MAUDE report 7637703 ↗
• InjuryApr 3, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WAS NOTED TO BE DEFLATING AND THE TUBE AT THE NECK END APPEARED DIFFERENT. IT WAS RE PORTED THAT THE TUBE WAS REPLACED, BUT THE REPLACEMENT TUBE¿S CUFF DID NOT MAINTAIN FULL INFLATION AND HAD AIR LEAKS NEAR THE CUFF VALVE.

  Patient problems: Extubate

  MAUDE report 7391811 ↗
• InjuryMar 28, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, THE CUFF WAS NOTED TO BE DEFLATING AND THE TUBE AT THE NECK END APPEARED DIFFERENT. IT WAS RE PORTED THAT THE TUBE WAS REPLACED, BUT THE REPLACEMENT TUBE¿S CUFF DID NOT MAINTAIN FULL INFLATION AND HAD AIR LEAKS NEAR THE CUFF VALVE.

  Patient problems: Extubate

  MAUDE report 7379174 ↗
• InjuryMar 26, 2018Human-Device Interface Problem; Human-Device Interface Problem

  ACCORDING TO THE REPORTER, THE TAPE WAS PULLED OFF THE CUFF INFLATION DEVICE AND IT SNAPPED OFF COMPLETELY. THEY QUICKLY PERFORMED AN EMERGENCY TRACHEOSTOMY CHANGE AND IT WAS SUCCESSFUL. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Extubate

  MAUDE report 7369896 ↗
• InjuryFeb 9, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE CUFF WAS DEFLATED SO AN EMERGENCY TRACHEOSTOMY CHANGE WAS PERFORMED. IT WAS REPORTED THAT THE DEFECTIVE PRODUCT IS UNAVAILABLE.

  Patient problems: Extubate

  MAUDE report 7260731 ↗
• InjuryFeb 9, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE PATIENT WAS DISTRESSED AND COUGHING, IT WAS REALIZED THAT THE CUFF WAS DEFLATED. IT WAS REPORTED THAT THE PATIENT¿S MOTHER PERFORMED AN EMERGENCY TRACHEOSTOMY CHANGE USING A SPARE TUBE OF THE SAME SIZE. IT WAS REPORTED THAT THE DEFECTIVE PRODUCT IS UNAVAILABLE.

  Patient problems: Extubate

  MAUDE report 7260521 ↗
• MalfunctionAug 10, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT PRIOR TO USE ON A PATIENT, AIR LEAK WAS FOUND. CUSTOMER INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 6787087 ↗

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-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-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-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-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-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
• 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