Shiley 5.5 PDLRecalls & reported problems
Covidien LP · Pediatric Tracheostomy Tube Long Cuffless · Class 2
All models of Shiley (387)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884522030045), received between Nov 29, 2017 and Feb 14, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Defective Device” (1 report).
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
Device problems
- Defective Device1
- No Apparent Adverse Event1
Patient problems
- Extubate1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 14, 2020No Apparent Adverse Event; No Apparent Adverse Event
ACCORDING TO THE REPORTER, THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9711814 ↗InjuryNov 29, 2017Defective Device; Defective Device
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT'S MOTHER HAD NOTICED THAT THERE WAS SOME IRRITATION ON THE PATIENTS SKIN. SHE HAD ATTEMPTED TO PLACE SOME GAUZE BETWEEN THE TRACHEOSTOMY TUBE AND THE PATIENTS SKIN, WHEN SHE FELT A SHARP EDGE ON THE TRACHEOSTOMY TUBE WITH HER HAND. THE PATIENT HAD RECEIVED A SUPERFICIAL CUT TO THE NECK THAT ALREADY HEALED WITH NO LONG TERM EFFECTS. THE TUBE WAS REMOVED AND REPLACED.
Patient problems: Extubate
MAUDE report 7067649 ↗
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 · TerminatedShiley 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
Other Tube tracheostomy and tube cuff devices
- Shiley 8CN85HCovidien LP · Tube tracheostomy and tube cuff1 recall2 deaths354 reports
- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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