Shiley 6.5 PDLRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884522030106), received between Dec 8, 2017 and Nov 13, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  ACCORDING TO THE REPORTER, THE DEVICE OBTURATOR COULD NOT REMOVE, EVEN IT WAS PULLED WITH A STRONG FORCE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9317676 ↗
• MalfunctionApr 25, 2018Material Discolored; Material Discolored

  ACCORDING TO THE REPORTER, PRIOR TO USE OF THE DEVICE ON A PATIENT, IT WAS REPORTED THAT THE TUBE TIP WAS FOUND DYED IN BLUE WHEN THE PACKAGE WAS OPENED. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7458974 ↗
• MalfunctionDec 8, 2017Material Discolored; Material Discolored

  MEDTRONIC RECEIVED A REPORT THAT PRIOR TO USE ON A PATIENT, THE CONNECTION BETWEEN THE TUBE AND FLANGE WAS FOUND DISCOLORED TO YELLOW. THE CUSTOMER REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7101823 ↗

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