Reports of 12 serious patient injuries, including breathing difficulties that impacted oxygen levels in patients.
Medtronic (NYSE: MDT) announced that on May 8, 2015, it began notifying hospitals and distributors worldwide that affected lots of its Covidien Shiley(TM) tracheostomy tubes were formed with a wider-angle bend than standard models manufactured after November 29, 2012. The company initiated the field action following a small number of customer complaints that included reports of 12 serious patient injuries, such as breathing difficulties that impacted oxygen levels immediately upon tube placement or discomfort.
Some Medtronic models of its guidewires from recent lots have the potential for the coating on their surface to delaminate and detach.
May result in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness.
Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps and Sutureless Connector Intrathecal Catheter Products Recalled.
Physician may need to re-inflate or replace deflated tube to ensure the continued breathing support of the patient.