Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threating in patients with compromised immune systems.
There is a reasonable probability of the following side effects of topical steroids which include but are not limited to skin changes, adrenal suppression, glaucoma, and cataracts.
FDA continues to recommend the use of thermoregulating devices (including forced air thermal regulating systems) for surgical procedures when clinically warranted.
Vulnerabilities, if exploited, could allow an unauthorized user to access patient's device, which could result in patient harm from rapid battery depletion or administration of inappropriate pacing.
Correction removed the indication for BTAI; Voluntary recall includes Zenith Alpha Thoracic products in sizes of 18-22mm, including the 26-22mm tapered device.