Shiley 3.0 NEORecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30884522026653), received between Jul 14, 2017 and Aug 12, 2021 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (5 reports).

1 other recall cover devices cleared under the same FDA submission (K945513); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, DURING USE, THE OBTURATOR WAS DIFFICULT TO INSERT AND REMOVE. THERE WAS NO PATIENT INJURY/HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12315591 ↗
• InjuryFeb 25, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, DURING THE CHANGE OF TRACHEOSTOMY TUBE, THE INSERTION WAS VERY PAINFUL DUE TO THE THICK AND RIGID MATERIAL. IT WAS ALSO STATED THAT THE DEVICE NEEDED MORE PRESSURE TO BE APPLIED WHICH MAY ALSO BE THE REASON OF THE PROBLEM. THE PATIENT WAS RE-INTUBATED. AFTER A THIRD ATTEMPT TO INTRODUCE THE 3RD CANNULA, A CANNULA OF A DIFFERENT LOT NUMBER WAS USED WITHOUT ISSUE. IN SUBSEQUENT INSERTION OF 2 CANNULAS OF THE REPORTED LOT NUMBER, THE PAINFULNESS AND SUFFOCATION STATUS WERE REPEATED. ALSO, BY CHECKING AND BY TOUCH CONTROL SHE COULD FEEL THE DIFFERENCE OF THE MATERIAL. THE PATIENT HAS HAD A PERMANENT TRACHEOSTOMY FOR MORE THAN 2 YEARS THAT REQUIRES VERY OFTEN CHANGES OF TUBES. THE USAGE OF THE TRACHEOSTOMY TUBES IS ON A REGULAR BASIS.

  Patient problems: Extubate

  MAUDE report 8367317 ↗
• InjuryFeb 25, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, DURING THE CHANGE OF TRACHEOSTOMY TUBE, THE INSERTION WAS VERY PAINFUL DUE TO THE THICK AND RIGID MATERIAL. IT WAS ALSO STATED THAT THE DEVICE NEEDED MORE PRESSURE TO BE APPLIED WHICH MAY ALSO BE THE REASON OF THE PROBLEM. THE PATIENT WAS RE-INTUBATED. AFTER A THIRD ATTEMPT TO INTRODUCE THE 3RD CANNULA, A CANNULA OF A DIFFERENT LOT NUMBER WAS USED WITHOUT ISSUE. IN SUBSEQUENT INSERTION OF 2 CANNULAS OF THE REPORTED LOT NUMBER, THE PAINFULNESS AND SUFFOCATION STATUS WERE REPEATED. ALSO, BY CHECKING AND BY TOUCH CONTROL SHE COULD FEEL THE DIFFERENCE OF THE MATERIAL. THE PATIENT HAS HAD A PERMANENT TRACHEOSTOMY FOR MORE THAN 2 YEARS THAT REQUIRES VERY OFTEN CHANGES OF TUBES. THE USAGE OF THE TRACHEOSTOMY TUBES IS ON A REGULAR BASIS.

  Patient problems: Extubate

  MAUDE report 8367316 ↗
• InjuryFeb 25, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, DURING THE CHANGE OF TRACHEOSTOMY TUBE, THE INSERTION WAS VERY PAINFUL DUE TO THE THICK AND RIGID MATERIAL. IT WAS ALSO STATED THAT THE DEVICE NEEDED MORE PRESSURE TO BE APPLIED WHICH MAY ALSO BE THE REASON OF THE PROBLEM. THE PATIENT WAS RE-INTUBATED. AFTER A THIRD ATTEMPT TO INTRODUCE THE 3RD CANNULA, A CANNULA OF A DIFFERENT LOT NUMBER WAS USED WITHOUT ISSUE. IN SUBSEQUENT INSERTION OF 2 CANNULAS OF THE REPORTED LOT NUMBER, THE PAINFULNESS AND SUFFOCATION STATUS WERE REPEATED. ALSO, BY CHECKING AND BY TOUCH CONTROL SHE COULD FEEL THE DIFFERENCE OF THE MATERIAL. THE PATIENT HAS HAD A PERMANENT TRACHEOSTOMY FOR MORE THAN 2 YEARS THAT REQUIRES VERY OFTEN CHANGES OF TUBES. THE USAGE OF THE TRACHEOSTOMY TUBES IS ON A REGULAR BASIS.

  Patient problems: Extubate

  MAUDE report 8367314 ↗
• InjuryFeb 25, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, DURING THE CHANGE OF TRACHEOSTOMY TUBE, THE INSERTION WAS VERY PAINFUL DUE TO THE THICK AND RIGID MATERIAL. IT WAS ALSO STATED THAT THE DEVICE NEEDED MORE PRESSURE TO BE APPLIED WHICH MAY ALSO BE THE REASON OF THE PROBLEM. THE PATIENT WAS RE-INTUBATED. AFTER A THIRD ATTEMPT TO INTRODUCE THE 3RD CANNULA, A CANNULA OF A DIFFERENT LOT NUMBER WAS USED WITHOUT ISSUE. IN SUBSEQUENT INSERTION OF 2 CANNULAS OF THE REPORTED LOT NUMBER, THE PAINFULNESS AND SUFFOCATION STATUS WERE REPEATED. ALSO, BY CHECKING AND BY TOUCH CONTROL SHE COULD FEEL THE DIFFERENCE OF THE MATERIAL. THE PATIENT HAS HAD A PERMANENT TRACHEOSTOMY FOR MORE THAN 2 YEARS THAT REQUIRES VERY OFTEN CHANGES OF TUBES. THE USAGE OF THE TRACHEOSTOMY TUBES IS ON A REGULAR BASIS.

  Patient problems: Extubate

  MAUDE report 8367313 ↗
• InjuryOct 10, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ACCORDING TO THE REPORTER, DURING THE CHANGE OF TRACHEOSTOMY TUBE, THE INSERTION OF THE CANNULA WAS VERY PAINFUL DUE TO THE THICK AND RIGID MATERIAL. THE DEVICE NEEDED MORE PRESSURE TO BE APPLIED WHICH MAY ALSO BE THE REASON OF THE PROBLEM. THE PATIENT WAS RE-CANNULATED. ADDITIONAL INFORMATION INDICATES THAT AFTER A THIRD ATTEMPT TO INTRODUCE THE 3RD CANNULA, A CANNULA OF A DIFFERENT LOT NUMBER WAS USED WITHOUT ISSUE. IN SUBSEQUENT INSERTION OF 2 CANNULAS OF THE REPORTED LOT NUMBER, THE PAINFULNESS AND SUFFOCATION STATUS WERE REPEATED. ALSO, BY CHECKING AND BY TOUCH CONTROL SHE COULD FEEL THE DIFFERENCE OF THE MATERIAL. THE PATIENT HAS HAD A PERMANENT TRACHEOSTOMY. FOR OVER 2 YEARS, THE USAGE OF THE TRACHEOSTOMY TUBES IS ON A REGULAR BASIS AND REQUIRES VERY OFTEN CHANGES OF TUBES.

  Patient problems: Extubate

  MAUDE report 7951434 ↗
• InjuryJul 14, 2017Connection Problem; Connection Problem

  MEDTRONIC RECEIVED A COMMUNICATION THAT WHILE IN USE ON A PATIENT, A SUCTION CATHETER COULD NOT BE INSERTED SMOOTHLY. THE TUBE WAS REPLACED WITH ANOTHER, AND THE CATHETER WAS ABLE TO BE INSERTED FINE. NO FURTHER PATIENT HARM WAS REPORTED.

  Patient problems: Extubate

  MAUDE report 6716228 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K945513. One submission often covers many models, so check the product and lot details in each record.

• Z-0997-2009 · Jan 14, 2009 · Terminated
  Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Assembled in Mexico. The pr