Shiley 6.0PLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20884522029053), received between Jun 13, 2017 and Nov 2, 2023 — classified as 4 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Inflation 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 2, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT BALLOON OF THE TRACHEOSTOMY TUBE HAD DAMAGE AROUND WHERE THE SYRINGE WAS POINTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18056732 ↗
• MalfunctionJul 6, 2023Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THERE WAS A CRACK AT THE PROXIMAL SITE OF THE INFLATION LINE (CANNULA SIDE) AND THE TRACH'S CUFF DID NOT INFLATE. THE CANNULA HAS BEEN USED SINCE MAY 11. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17267133 ↗
• MalfunctionSep 15, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, 3 HOURS AND 11 DAYS AFTER STARTING TO USE THE TRACHEOTOMY TUBE, IT WAS FOUND OUT THAT IT ONLY HAD THE INFLATION LINE AND THE PILOT BALLOON WAS DISCONNECTED FROM THE TUBE AND FELL. THE INFLATION LINE WAS FOUND CUT. THE TRACHEOTOMY TUBE MAIN UNIT WAS NOT REMOVED FROM THE PATIENT, AND THERE WAS NO BLEEDING FROM THE PNEUMO-HOLE. THE DEVICE WAS IMMEDIATELY REPLACED WITH A NEW ONE AND THERE WAS NO HEALTH HAZARD ON THE PATIENT . THE PATIENT OFTEN PULLED THE ARTIFICIAL NOSE AND RESPIRATORY CIRCUIT BECAUSE OF THIS EVENT.

  Patient problems: Unintended Extubation

  MAUDE report 12473922 ↗
• MalfunctionJun 18, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AT 2 AM, THE NUTRITION INJECTION WAS COMPLETED, AND POSTURE CHANGE AND SUCTION WERE PERFORMED AS USUAL. VT DECREASED FROM 110 TO 130 AFTER SUCTION. A LEAK SOUND WAS HEARD. NO IMPROVEMENT WAS OBSERVED EVEN AFTER THE PATIENT'S POSTURE WAS ADJUSTED. WHEN THE PRESSURE OF THE CUFF WAS MEASURED, IT DECREASED TO 11 CMH2O, SO IT WAS FIXATED TO 20 CMH2O. A DECREASE IN VT WASOBSERVED IMMEDIATELY, AND A LEAK SOUND WAS CONFIRMED AGAIN, UPON CHECKING THE PRESSURE OF THE CUFF, IT DECREASED TO 10 CMH2O. THE PRODUCT WAS REPLACED WITH A NEW TUBE. THE REMOVED PART WAS LEFT ALONE WITH THE CUFF INFLATED, BUT IT COULD NOT BE CONFIRMED IF THE AIR IN THE CUFF HAD COME OUT. IT WAS DETERMINED THAT IT WAS UNKNOWN AT THE SITE WHETHER IT WAS A PROBLEM WITH THE TUBE OR A PROBLEM WITH THE PRESSURE GAUGE.

  Patient problems: Unintended Extubation

  MAUDE report 12024540 ↗
• MalfunctionJan 29, 2021Use of Device Problem; Use of Device Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11250101 ↗
• MalfunctionFeb 6, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE OBTURATOR WAS INSERTED, A RESISTANCE WAS FELT AND HARD TO ENTER. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9676636 ↗
• MalfunctionNov 8, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD CUFF AIR LEAK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9298721 ↗
• InjuryOct 29, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE DEVICE'S CATHETER MOUNT CAME OFF. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 9251976 ↗
• MalfunctionAug 16, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE DEVICE HAD A STRONG, NARROWING AND BURR RESISTANCE WHEN INSERTING THE OBTURATOR. THE CUSTOMER INDICATED NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8900330 ↗
• MalfunctionNov 28, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF WAS CHECKED AND BECAUSE AN AIR LEAK WAS FOUND, THE DEVICE WAS NOT USED. THE CUSTOMER ALSO REPORTED THAT UPON RECHECKING THE DEVICE THE ISSUE WAS NOT DUPLICATED. IT WAS INDICATED THAT THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8110840 ↗
• InjuryJun 29, 2017Air Leak; Inflation Problem; Air Leak; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THE TRACHEOSTOMY TUBE HAD A CUFF LEAK. MEDTRONIC IS REQUESTING ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES OF THE EVENT.

  Patient problems: No Information

  MAUDE report 6679822 ↗
• InjuryJun 16, 2017Inflation Problem; Material Integrity Problem; Inflation Problem; Material Integrity Problem

  MEDTRONIC RECEIVED A REPORT THAT THE TRACHEOSTOMY TUBE'S CANNULA WAS DEFECTIVE. MEDTRONIC FOLLOWED UP WITH THE CUSTOMER REGARDING THE CIRCUMSTANCES OF THE EVENT. THE CUSTOMER INDICATED THAT THE PATIENT INVOLVED WAS A CHRONIC PATIENT WITH HOME CARE, THEREFORE HAD A HEALTH CARE PROFESSIONAL IN CHARGE. THE CANNULA WAS CHECKED BEFORE ITS INSTALLATION AND NO PROBLEMS DETECTED. THE PATIENT WAS REINTUBATED WITHOUT COMPLICATIONS.

  Patient problems: Extubate

  MAUDE report 6648095 ↗
• MalfunctionJun 13, 2017Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  MEDTRONIC RECEIVED A REPORT THAT WHILE IN USE, THE DEVICE HAD AN INFLATION/DEFLATION ISSUE. THERE WAS NO PATIENT INJURY REPORTED. THE CUSTOMER DISCARDED THE PRODUCT, THEREFORE NO PRODUCT WILL BE RETURNED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6638334 ↗
• InjuryJun 13, 2017Inflation Problem; Inflation Problem

  MEDTRONIC RECEIVED REPORT THAT THE DEVICE HAD A CUFF INFLATION/ DEFLATION ISSUE RELATED TO THE PILOT VALVE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6637426 ↗

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-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-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-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-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-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