[UPDATED 07/15/2015] Recall classified by FDA as Class I. Health care providers and facilities should immediately stop using the recalled tubes and use alternatives instead. Required actions for customers added- Quarantine and discontinue use of the affected devices, Return affected product using the instructions in the Recall Notice.
AUDIENCE: Risk Manager, Nursing, Anesthesiology, Otolaryngology, Surgery, Critical Care Medicine
ISSUE: Medtronic announced that on May 8, 2015, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels, immediately upon tube placement or discomfort. Replacement of the tracheostomy tube with product manufactured prior to November 29, 2012 addressed the patient breathing difficulty or discomfort.
The recall includes specific lots from eight product lines that were manufactured after November 29, 2012. See the Press Release for detailed product recall information.
BACKGROUND: A Shiley tracheostomy tube is put through a patient's trachea (windpipe) during a tracheostomy procedure to help provide an airway and facilitate the ability to breathe.
RECOMMENDATION: Customers and distributors who have provided the recalled Shiley tracheostomy tubes to a homecare provider or patient must notify the primary care physician and the homecare provider that these products should be discontinued from use and returned. If one of the recalled products is currently in use in a homecare patient, and the patient is not experiencing any discomfort, breathing difficulties or any other issues related to the tube, it is recommended that the patient's physician evaluate the continued use. If the physician advises leaving the tracheostomy tube in place, the tube must be replaced with an alternate device at the next tube exchange.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[07/15/2015- Recall Notice- FDA]
[06/23/2015 - Press Release - Medtronic]