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FDA Announcements

Bio Meds

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22Dec

FDA Recall for Arrow International, LLC, a subsidiary of Teleflex, Inc

Arrow International, LLC, a subsidiary of Teleflex, Inc, is recalling Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps after receiving complaints that battery power is not lasting as expected. The FDA has identified this as a Class I recall. A fully charged battery should last 90 minutes; however, multiple users report the devices are experiencing shorter run times. The battery life warnings, designed to sound at 20, 10, and 5 minutes of battery power remaining, are also inaccurate as the battery depletes more rapidly than indicated. There have been 241 complaints, with 135 reported pump stops. No deaths have been reported related to this issue.

10Oct

LivaNova (TandemLife) Recalls LifeSPARC System

LivaNova (TandemLife) has recalled the LifeSPARC controller, part of the LifeSPARC system, because of a software malfunction that may cause the controller's monitoring feature to wrongly enter critical failure mode, causing the pump to stop working. The FDA has identified this as a Class I recall. To date, LivaNova has received 66 complaints about the fault. The FDA has received reports of two injuries and no deaths.

05Jul

FDA recall for The HeartWare Ventricular Assist Device (HVAD) by Medtronic, Inc.

The FDA has identified this as a Class I recall for The HeartWare Ventricular Assist Device (HVAD) by Medtronic, Inc., the recall is due to welding defects that allow separation of the two cell battery packs used to power the system. The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging. As a result, the battery may fail suddenly. If this malfunction occurs, it will trigger a Power Disconnect alarm on the controller screen and in the Alarm Log tab of the HVAD Monitor while the affected battery is still connected to the controller.

18Nov

GE Healthcare Receives FDA Clearance for First Artificial Intelligence (AI) Algorithm

GE Healthcare today announced it has received Food and Drug Administration (FDA) approval for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.

29Sep

FDA approves TransMedics’ OCS Heart system

  • FDA approves TransMedics OCS Heart system

TransMedics Group has secured approval from the US Food and Drug Administration (FDA) for its OCS Heart System that is developed for use with organs collected from donors after brain death (DBD).

The OCS Heart System is designed to preserve DBD donor hearts deemed unsuitable for procurement and transplantation at initial assessment due to limitations of prolonged cold static cardioplegic preservation.

28Sep

Emergency Reversal of Anticoagulation

  • Emergency Reversal of Anticoagulation

The risk of bleeding varies with the type of anticoagulant agent used. The incidence of bleeding while on warfarin has been estimated at 15-20% per year, with life-threatening bleeding occurring.
At a rate of 1-3% per year. Providers should remember that all patients with emergent or life-threatening bleeding require attention to basic interventions, including cessation of anticoagulation therapy, blood product transfusions, and assessment for airway protection.