Shiley 6.0 PDLRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884522030083), received between Nov 6, 2018 and Dec 30, 2019 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE DEVICE'S ARBITRATOR DID NOT SLIDE CORRECTLY IN. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9530124 ↗
• MalfunctionDec 20, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE DEVICE'S OBTURATOR DID NOT SLIDE CORRECTLY IN. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS IN JURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9500358 ↗
• MalfunctionDec 20, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE DEVICE'S OBTURATOR DID NOT SLIDE CORRECTLY AND WAS HARD TO PUSH THROUGH. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9500291 ↗
• MalfunctionDec 17, 2019Defective Component; Defective Component

  ACCORDING TO THE REPORTER, THE DEVICE OBTURATOR DOES NOT SLIDE CORRECTLY AND NEED FORCE TO FIT IN. THERE WAS NO ALLEGATION OF PATIENT DEATH OR SERIOUS INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9481945 ↗
• MalfunctionDec 17, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE DEVICE OBTURATOR DID NOT SLIDE IN CORRECTLY AND NEED TO FORCE IT IN. THERE WAS NO ALLEGATION OF PATIENT DEATH OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9478667 ↗
• InjuryNov 19, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THERE WAS A STRONG RESISTANCE WITH THE OBTURATOR, SO IT WAS DIFFICULT TO COME OUT. IT WAS CONSIDERED THAT THE TUBE HAVE BEEN DEFORMED DUE TO THE ANGLE OF THE PATIENT'S NECK DURING INTUBATION. RECANNULATION OF A REPLACEMENT TUBE WAS REQUIRED/PERFORMED.

  Patient problems: Extubate

  MAUDE report 9344893 ↗
• InjuryNov 17, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE HAD CUFF PRESSURE THAT IMMEDIATELY DECREASED AND IT COULD NOT BE CONTROLLED. THE PATIENT WAS REINTUBATED.

  Patient problems: Extubate

  MAUDE report 9333643 ↗
• MalfunctionJul 24, 2019Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE DEVICE HAD INNER CANNULA ISSUE WITH HAVING DIFFICULTY IN PUSHING IT IN TO HIS NECK. DR. (B)(6) STATES THAT SHE ALSO EXPERIENCED "FOLDING IN HALF OF THE INNER CANNULA CLOSE TO THE PHALANGE" DURING PLACEMENT WITH AND WITHOUT THE OBTURATOR IN PLACE. THIS DID NOT RESULT IN AIRWAY COMPROMISE AND PATIENT WAS DISCHARGED HOME. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824583 ↗
• InjuryNov 18, 2018Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, THE UNIT HAD A DISCOLORED PART LIKE A STAIN ON THE BACK OF THE TUBE. THE CUSTOMER INDICATED THAT THE PATIENT WAS RECANNULATED.

  Patient problems: Extubate

  MAUDE report 8083020 ↗
• InjuryNov 6, 2018Material Deformation; Material Deformation

  ACCORDING TO THE REPORTER, WHEN THE PRODUCT WAS INSERTED INTO THE TRACHEA BY THE PATIENT AT HOME, BLEEDING OCCURRED. THE CUSTOMER REPORTED THAT THERE WERE PROTRUSIONS LIKE A HANGNAIL ON THE TIP OF THE PRODUCT WHICH WERE CUT BY SCISSORS.

  Patient problems: Extubate

  MAUDE report 8041161 ↗

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