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December 2016 MedSun Newsletter
Recalls and Safety Alerts:
FindrWIRZ Guidewire System by SentreHeart: Class I Recall
PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream...
Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement
Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal...
HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall
A loose power connector which may cause the rear portion of the pump's driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures…
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers
Update and additional information regarding the SynCardia temporary Total Artificial Heart (TAH-t) Companion 2 Driver System (C2 Driver System)…
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