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September MedSun Newsletter
Recalls and Safety Alerts:
Forced Air Thermal Regulating Systems: Healthcare Provider Letter
The FDA recently became aware that some health care providers and patients may be avoiding the use of forced air thermal regulating systems during surgical procedures due to concerns of a potential increased risk of surgical site infection. After a thorough review of available data, the FDA has been unable to identify a consistently reported association between the use of forced air thermal regulating systems and surgical site infection and continues to recommend the use of thermoregulating devices for surgical procedures when clinically warranted…
Implantable Cardiac Pacemakers by Abbott (formerly St. Jude Medical): Safety Communication
The FDA has reviewed information concerning potential cybersecurity vulnerabilities associated with St. Jude Medical's RF-enabled implantable cardiac pacemakers and has confirmed that these vulnerabilities, if exploited, could allow an unauthorized user to access a patient's device using commercially available equipment…
Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Recall Correction and Removal of Specific Sizes from Market
This correction removed the indication for blunt thoracic aortic injury, also known as BTAI or “transection” of the aorta because Cook has received an increase in reports of graft thrombosis and occlusion with these grafts specifically in the treatment of BTAI…
Liquid-filled Intragastric Balloon Systems: Letter to Healthcare Providers
FDA is issuing an update to alert health care providers of five reports of unanticipated deaths that occurred from 2016 to present in patients with liquid-filled intragastric balloon systems used to treat obesity…
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