Heart Surgery
FDA: Class I recall of Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs
Editor's Note The Food and Drug Administration (FDA), on October 29, identified the recall by Datascope/Getinge/Maquet of its Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump battery packs as Class I, the most serious. The recall was initiated because of the risk of the battery failing and having a shortened run time, which…
The Joint Commission seeking comments on new heart attack certification program
Editor's Note The Joint Commission, on October 27, announced that it will launch a new Comprehensive Heart Attack Center Certification in July 2022 and is seeking comments on the newly proposed standards. The Joint Commission also has revised standards for its current certification programs: Acute Heart Attack Ready and Primary…
FDA: Class I recall of DeRoyal surgical procedure packs
Editor's Note The Food and Drug Administration (FDA), on June 25, identified the recall of DeRoyal Industries’ surgical procedure packs as Class I, the most serious. The recall was initiated because the packs contain 1% lidocaine that had been mislabeled as 0.5% bupivacaine. The procedure packs are used for cardiac…
First assistants bring expertise and efficiency to the OR table--Part 2
First assistants (FAs) can play an important role in achieving optimal outcomes and higher surgical case volumes. Part 1 of this two-part series discussed types, education, and certification of FAs (OR Manager, May 2021, pp 1, 15-18). Part 2 answers questions related to risk management and oversight, and discusses possible…
Trends in surgical caseloads during COVID-19
Editor's Note Urban hospitals bounced back faster than rural hospitals from surgical caseload decreases caused by the COVID-19 pandemic, finds a new study released May 13 by Caresyntax, a Boston-based developer of surgical intelligence and automation technologies. The study, “The State of Surgery: An Analysis of Surgical Trends During the…
FDA: Class I recall of Medtronic’s Extracorporeal Blood Pumping Console
Editor's Note The Food and Drug Administration (FDA), on April 20, identified the recall of Medtronic’s Bio-Console 560 Extracorporeal Blood Pumping Console as Class I, the most serious. The Console is used during heart surgery to pump and return blood to a patient during cardiopulmonary bypass. The recall was initiated…
FDA issues Class I recall of certain Medtronic ICDs, CRT-Ds
Editor's Note The Food and Drug Administration (FDA), on April 12, identified the recall of Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia, and Visia implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) as Class I, the most serious. The recall was initiated because of an unexpected and rapid…
FDA: Class I recall of Medtronic’s Valiant Navion Thoracic Stent Graft System
Editor's Note The Food & Drug Administration (FDA), on April 9, identified the recall of Medtronic’s Valiant Navion Thoracic Stent Graft System as Class I, the most serious. The recall was initiated because of the risk of stent fractures and endoleak concerns. The system is used to repair lesions of…
FDA: Class I recall of Medtronic Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface
Editor's Note The Food and Drug Administration (FDA), on March 24, identified the recall by Medtronic of its Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface as Class I, the most serious. The recall was issued because of potentially elevated levels of harmful bacterial endotoxins. Use of a device…
FDA: Class I recall of Medtronic's HVAD Pump Implant Kits
Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…
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