Shiley 9UN90RRecalls & reported problems
Covidien LP · Adult Flexible Tracheostomy Tube Cuffless Reusable Inner Cannula · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521205536), received between Jun 25, 2024 and Jun 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Human-Device Interface Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K150844); 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.
Reports received per month
Recalls naming this device
- Mar 24, 2023Open, Classified
A manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure connections with 15mm caps and other 15mm circuit components and accessories. An unsecure connection could lead to respiratory failure, dyspnea, treatment delay, tissue injury, or bleeding.
Z-1357-2023 · Root cause: Component change control · FDA record ↗
Most reported problems
Device problems
- Human-Device Interface Problem1
Patient problems
- Airway Obstruction1
- Discomfort1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 25, 2024Human-Device Interface Problem; Human-Device Interface Problem
ACCORDING TO THE REPORTER, DURING USE, THE SIZE IN THE BOX OF THE FIRST DEVICE WAS INCORRECT. THE PATIENT USED A CALIPER TO CHECK THE SIZE AND FOUND THAT THE SIZES LISTED ON THE BOX WERE INCORRECT. THE PATIENT MENTIONED THAT IT WAS MUCH SMALLER THAN THE PREVIOUS VERSION, AND THE INNER AND OUTER DIAMETERS WERE NOT THE SAME. THE PATIENT AIRWAY WAS RESTRICTED AND NOISY. THE PATIENT WENT UP TO A 9-MM TUBE, WHICH WAS CLOSER TO THE SIZE OF THE FIRST DEVICE, BUT STILL FELT MORE NARROWED, WHICH CAUSED ADDED NOISE AND VOLUME RESTRICTION, AND PREFERRED TO HAVE THE OLD STYLE BACK.
Patient problems: Airway Obstruction; Discomfort
MAUDE report 19607292 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K150844. One submission often covers many models, so check the product and lot details in each record.
- Z-1390-2025 · Feb 26, 2025 · Open, ClassifiedShiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula, REF: 7CN80R
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.