Covidien recalls Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula

Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.

On 2/26/2025, recall notices were mailed and/or emailed to Risk Managers, Directors of Respiratory Care, Anesthesiology, Pulmonary/Intensive Care and ENT who were asked to do the following: 1) For patients with affected devices currently in place, a replacement is required. The patient's medical team should assess the overall patient risk when considering the timing of replacement. Clinicians should continue to follow current product Instructions For Use (IFU) along with facility specific policies and procedures. 2) Quarantine and return all unused product from the affected lot in your inventory to the firm. 3) Pass on this notice to all those who need to be aware within your organization or to any organization where the potentially affected product from the specified lot has been transferred or distributed. 4) Complete and return the enclosed Customer Confirmation Form via email to rs.gmbmitgfca@medtronic.com If you have any questions regarding this communication, contact the firm's Customer Service at 800-962-9888, Option 2.

• FDA enforcement recordOfficial FDA database entry for Z-1390-2025
• FDA 510(k) clearance · K150844The device's official FDA premarket clearance record
• FDA device classification · JOHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find CovidienSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.