Shiley 4.5PDCRecalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 20884522029114), received between Jan 10, 2018 and Jun 14, 2023 — classified as 13 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (10 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 14, 2023Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF OF THE TRACH CANNULA WAS NO LONGER INFLATING WITHIN 30 DAYS OF USE. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Unintended Extubation

  MAUDE report 17131394 ↗
• MalfunctionNov 10, 2022Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF HAD A LEAK. RECANNULATION WAS DONE.

  Patient problems: Unintended Extubation

  MAUDE report 15772149 ↗
• MalfunctionMay 7, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING PRE-CHECK TEST, IT WAS FOUND THAT THE CUFF WILL NOT HOLD AIR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14317410 ↗
• MalfunctionApr 15, 2022Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE INFLATION LINE OF THE DEVICE WAS FOUND TO BE CURVED AND THE CUFF WOULD NOT INFLATE OR DEFLATE BECAUSE AIR COULD NOT BE INJECTED WITH SYRINGE. THE SALES REP CHECKED IT AND AIR COULD BE INJECTED NORMALLY. THE DEVICE HAS BEEN REPLACED. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118626 ↗
• MalfunctionFeb 25, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, IT WAS EASIER TO COME OFF FROM THE CONNECTOR THAN USUAL WHEN CONNECTED TO THE CATHETER MOUNT. THERE WAS NO PATIENT HARM.

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

  MAUDE report 13603488 ↗
• MalfunctionFeb 25, 2022Connection Problem; Connection Problem

  ACCORDING TO THE REPORTER, IT WAS EASIER TO COME OFF FROM THE CONNECTOR THAN USUAL WHEN CONNECTED TO THE CATHETER MOUNT. THERE WAS NO PATIENT HARM.

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

  MAUDE report 13603442 ↗
• MalfunctionAug 31, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD AN AIR LEAK FROM THE CONNECTION PORT OF THE CUFF AND THE INFLATION LINE. THERE WAS NO PROBLEM IN THE PRE-USE INSPECTION, BUT AFTER SEVERAL DAYS OF USE, THE CUFF DID NOT DEFLATE PROPERLY, AND IT WAS CONFIRMED. THE PATIENT REQUIRED AN EXCHANGE AT THE EMERGENCY OUTPATIENT DEPARTMENT. THE SAME EVENT OCCURRED TWICE.

  Patient problems: Unintended Extubation

  MAUDE report 12399867 ↗
• MalfunctionAug 31, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD AN AIR LEAK FROM THE CONNECTION PORT OF THE CUFF AND THE INFLATION LINE. THERE WAS NO PROBLEM IN THE PRE-USE INSPECTION, BUT AFTER SEVERAL DAYS OF USE, THE CUFF DID NOT DEFLATE PROPERLY, AND IT WAS CONFIRMED. THE PATIENT REQUIRED AN EXCHANGE AT THE EMERGENCY OUTPATIENT DEPARTMENT. THE SAME EVENT OCCURRED TWICE.

  Patient problems: Unintended Extubation

  MAUDE report 12393842 ↗
• MalfunctionJul 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LEAK FROM THE INFLATION LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217305 ↗
• MalfunctionJul 23, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AIR LEAKAGE OCCURRED FROM THE CUFF ABOUT 10 DAYS AFTER USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217052 ↗
• MalfunctionJul 23, 2021Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, AIR LEAKAGE OCCURRED FROM THE CUFF ABOUT 10 DAYS AFTER USE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217040 ↗
• MalfunctionJul 23, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A LEAK FROM THE INFLATION LINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12217001 ↗
• MalfunctionApr 15, 2021Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD A CUFF INFLATION/DEFLATION ISSUE. THE CUFF WOULD ONLY INFLATE WHEN THE SYRINGE WAS CONNECTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675619 ↗
• InjuryOct 31, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE WAS DISCONNECTED IN THE INFLATION LINE. THE INFLATION LINE GOT DISCONNECTED JUST BY PULLING A LITTLE IMMEDIATELY AFTER THE TUBE EXCHANGE. THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate; Unintended Extubation

  MAUDE report 10767495 ↗
• InjuryOct 31, 2020Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, TWO WEEKS AFTER PLACEMENT, THE DEVICE HAD AIR LEAK. THE DEVICE WAS REPLACED. UPON CHECKING THE PRODUCT, CUFF LEAKAGE WAS FOUND BUT THE LEAKAGE LOCATION COULD NOT BE IDENTIFIED. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate; Unintended Extubation

  MAUDE report 10767478 ↗
• InjuryJul 31, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S INFLATION LINE CAME OFF FROM THE CONNECTION PART OF THE CANNULA. THE PATIENT HAD A REPLACEMENT OF THE TUBE.

  Patient problems: Extubate

  MAUDE report 10352829 ↗
• InjuryApr 20, 2020Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, 14 DAYS AFTER THE START OF USING, THE DEVICE¿S TUBE TIP WAS COLORED DARK THAT LOOKED LIKE A MOLD AFTER THE TRACHEOSTOMY CANNULA REPLACEMENT AND IT WAS OCCURRED 2 CASES CONSECUTIVELY. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 9979455 ↗
• InjuryMar 26, 2020Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, 14 DAYS AFTER THE START OF USING, THE DEVICE¿S TUBE TIP WAS COLORED DARK THAT LOOKED LIKE A MOLD AFTER THE TRACHEOSTOMY CANNULA REPLACEMENT AND IT WAS OCCURRED 2 CASES CONSECUTIVELY. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 9886667 ↗
• InjuryMar 26, 2020Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, 14 DAYS AFTER THE START OF USING, THE DEVICE¿S TUBE TIP WAS COLORED DARK THAT LOOKED LIKE A MOLD AFTER THE TRACHEOSTOMY CANNULA REPLACEMENT AND IT WAS OCCURRED 2 CASES CONSECUTIVELY. THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 9886637 ↗
• InjuryNov 26, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER DURING USE, THE DEVICE¿S INFLATION LINE WAS DISCONNECTED FROM THE TUBE AROUND 20 DAYS AFTER EXCHANGE. THE PATIENT WAS REINTUBATED FOR PERIODIC EXCHANGE TO SOLVE THE PROBLEM.

  Patient problems: Extubate

  MAUDE report 9380215 ↗
• MalfunctionOct 14, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  ACCORDING TO THE REPORTER, DURING DEVICE REPLACEMENT, A BLACK STAIN WAS FOUND TO BE ADHERED TO THE CONNECTOR PART OF THE EXTUBATED TUBE. IT WAS INDICATED THAT IT WAS A MOLD LIKE STAIN WAS FOUND TO BE ADHERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9186626 ↗
• InjurySep 26, 2019Gas/Air Leak; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN AIR LEAK. IT WAS INDICATED THAT THE EVENT OCCURRED 30 DAYS AFTER OF USING THE DEVICE. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 9122883 ↗
• MalfunctionApr 18, 2019Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, THE INSIDE OF THE SLIP JOINT HAD TURNED BLUE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8527161 ↗
• InjuryJan 7, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE DEVICE AIR LEAKAGE BECAME NOTICEABLE FROM ABOUT ONE WEEK AFTER THE REPLACEMENT. THE SAME EVENT OCCURRED SEVERAL TIMES WITHIN SEVERAL MONTHS. THE PATIENT WAS REINTUBATED. CUSTOMER REPORTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: Extubate

  MAUDE report 8223543 ↗
• InjuryJan 7, 2019Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING USE, AIR LEAKAGE WAS NOTICED ABOUT ONE WEEK AFTER THE REPLACEMENT. THE CUSTOMER REPORTED PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 8223540 ↗

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-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-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-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-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-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-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