FDA: Class I recall of SentreHeart’s FindrWIRZ Guidewire System
Editor's Note The Food and Drug Administration (FDA) on November 22 categorized the recall by SentreHeart (Redwood City, California) of its FindrWIRZ Guidewire System as Class I, the most serious. The recall was initiated because the PTFE coating may separate from the packaging and potentially cause serious injuries to patients. The…
FDA: Class I recall of HeartWare Ventricular Assist Device Pumps
Editor's Note The Food and Drug Administration on October 24 categorized HeartWare Inc’s recall of its HeartWare Ventricular Assist Device Pumps as Class I, the most serious. The recall is because of a design problem with the driveline connector that connects the pump to the external controller and power source.…
FDA: Class I recall of Willy Rusch Tracheostomy Tube Set
Editor's Note The Food and Drug Administration (FDA) on October 20 categorized the recall by TeleFlex Medical of its Willy Rusch Tracheostomy Tube Set as Class I, the most serious. The recall was issued because of the possibility that the connector may disconnect from the tracheostomy tube during use on…
FDA: Medtronic recalls certain neurovascular products
Editor's Note The Food and Drug Administration (FDA) on October 18 announced the recall by Medtronic of certain lots of its Pipeline embolization device, Alligator retrieval device, and X-Celerator hydrophilic guidewire. The recall also includes the stylet containing UltraFlow flow directed micro catheters and Marathon flow directed micro catheters. The…
FDA: Class I recall of Skintact DF29N Multi-function Defibrillation Electrodes
Editor's Note The Food and Drug Administration (FDA) on October 14 categorized the recall by Leonhard Lang of its Skintact DF29N Multi-function Defibrillation Electrodes as Class I, the most serious. The electrode is being recalled because of a connector compatibility issue with the Welch Allyn automatic external defibrillator (AED), model…
FDA, CDC issue alerts on Stӧckert 3T Heater-Cooler System
Editor's Note The Food and Drug Administration (FDA) on October 13 updated its Safety Alert on the Stӧckert 3T Heater-Cooler System by LivaNova to provide new information from the Centers for Disease Control and Prevention (CDC) about Mycobacterium chimaera infections associated with the use of the system in US patients…
FDA issues Safety Alert for St Jude defibrillators
Editor's Note The Food and Drug Administration on October 11 issued a Safety Alert for implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) by St Jude Medical (Little Canada, Minnesota). In some cases, full battery drainage can occur in a day to a few weeks after the patient…
FDA: Nurse Assist recalls IV Flush Syringes
Editor's Note The Food and Drug Administration (FDA) on October 5 announced the recall by Nurse Assist of its IV Flush Syringes because of a potential link to Burkholderia cepacia bloodstream infections. The syringes are being recalled until a thorough investigation can be completed by the FDA, Centers for Disease…
FDA: Vascular Solutions recalls Twin-Pass Dual Access Catheters
Editor's Note The Food and Drug Administration on October 5 announced the recall by Vascular Solutions, Inc, (Minneapolis, Minnesota) of its Twin-Pass Dual Access Catheters used in catheterization procedures. The catheters have been recalled because of the potential for excess manufacturing material to remain at the tip of the catheter…
FDA: Recall of Baxter 50 mm 0.2 micron filters
Editor's Note The Food and Drug Administration on October 3 announced the recall by Baxter International (Deerfield, Illinois) of its 50 mm 0.2 micron filters because of the potential for a missing filter support membrane and for potential presence of particulate matter. The filter is a bacteria and particulate filter…
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