Recent FDA Class 1 recall designations include anesthesia systems, aortic root cannula

Editor's Note

The US Food and Drug Administration (FDA) has designated recent medical device recalls involving GE Healthcare’s Carestation anesthesia system, Medtronic aortic root cannula systems, Zoll Circulation’s AutoPulse NXT Resuscitation System, and Medtronic’s Bravo CF Capsule Delivery Devices as Class 1, the most severe category indicating serious risk of injury or death.

As detailed in FDA’s June 23 announcement, GE recalled certain Carestation devices due to the risk of ineffective ventilation in Volume Control Ventilation (VCV) mode, potentially resulting in hypoxia and death. No injuries or deaths have been reported. Instructions detailed in the full announcement include avoiding VCV mode until the issue is corrected, conducting a Ventilation Screening Test per GE’s instructions, and refrain from using the system if it fails testing. 

According to a separate June 23 announcement, Medline Industries issued a correction for procedure kits containing Medtronic Aortic Root Cannula due to the potential of excess material in male luers.  Risks include  procedure delay, neurological deficits, and stroke. No injuries or deaths have been reported so far. In response to the issue, Medline is reportedly providing warning stickers that advise using an aortic root cannula from another supplier.   

ZOLL Circulation’s recall of the the AutoPulse NXT Resuscitation System is reportedly due to an error in determining compression depth, potentially delaying life-saving cardiopulmonary resuscitation (CPR). No injuries or deaths have been reported. The FDA announcement offers affected model numbers, instructions for users, and more.

According to FDA’s June 24 announcement, Medtronic and subsidiary Given Imaging Inc. have issued two letters to affected customers recommending certain Bravo CF Capsule Delivery Devices (designed to attach a pH monitoring capsule to the esophagus) be removed due to misapplication of adhesive during manufacturing.  Risks aspiration/inhalation, perforation of esophagus, obstruction of the airway, hemorrhage/blood loss/bleeding, laceration of the esophagus, a delay in diagnosis, and foreign bodies remaining in the patient. Medtronic has reported 33 serious injuries and no deaths associated with this issue. The full report offers further detail on identifying affected devices and mitigating risks.