FDA: Class I recall of Medtronic’s Dual Chamber Implantable Pulse Generators
Editor's Note The Food & Drug Administration (FDA) on February 15 identified Medtronic, Inc’s (Dublin, Ireland) recall of it’s Dual Chamber Implantable Pulse Generators (IPGs) as Class I, the most serious. The recall was initiated because of the possibility of a software error that can result in a lack of…
FDA: Class I recall of Edwards Lifesciences Swan-Ganz Thermodilution Catheter
Editor's Note The Food and Drug Administration (FDA) on February 5 identified the recall by Edwards Lifesciences (Irvine, California) of its Swan-Ganz Thermodilution Catheter as Class I, the most serious. The recall was initiated because of incorrect assembly and reversal of catheter lumens that can expose the patient to serious…
Medtronic recalls nearly 157,000 dual-chamber pacemakers
Editor's Note Medtronic published an urgent recall on January 7 for a subset of its dual-chamber pacemakers because some may temporarily lose their ability to pace the heart. The recall affects 156,957 devices distributed worldwide between March 10, 2017, and January 7, 2019, under the brand names Adapta, Versa, and…
FDA: Sun Pharmaceutical recalls four lots of Vecuronium Bromide
Editor's Note The Food & Drug Administration (FDA) on January 8 announced the recall by Sun Pharmaceutical Industries, Inc (Cranbury, New Jersey) of three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder) (Lots: JKS0443A, JKS0444A, JKS0477A), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder)…
FDA: Class I recall of Medtronic’s Synergy, Stealth Station S7 Cranial Software
Editor's Note The Food & Drug Administration (FDA) on January 8 identified the recall of Medtronic’s Synergy Cranial Software and Stealth Station S7 Cranial Software as Class I, the most serious. The Software is used with the Stealth Station Surgical Navigation System to provide detailed 3D images of a patient’s…
FDA: Class I recall of Synaptive Medical’s BrightMatter Guide with SurfaceTrace Registration
Editor's Note The Food and Drug Administration (FDA) on November 30 identified the recall by Synaptive Medical of its BrightMatter Guide with SurfaceTrace Registration, which is used to perform neurosurgical procedures, as Class I, the most serious. The recall was initiated because of a software defect that could potentially result…
FDA: Class I recall of Zimmer Biomet spinal fusion, long bone stimulators
Editor's Note The Food & Drug Administration (FDA) on November 26 identified the recall by Zimmer Biomet (Warsaw, Indiana) of its Osteogen Implantable Bone Growth Stimulator, SpF PLUS-Mini Implantable Fusion Stimulator, and SpF-XL Implantable Spinal Fusion Stimulator as Class I, the most serious. The recall was initiated because of the…
FDA: Fresenius Kabi recalls sodium chloride injection
Editor's Note The Food and Drug Administration (FDA) on November 20 announced the nationwide recall by Fresenius Kabi USA (Lake Zurich, Illinois) of 163 lots of sodium chloride injection, USP, 0.9%, 10 mL and 20 mL vials. The recall was initiated because the product insert incorrectly states that the vial…
FDA: Class I recall of Cardiosave Hybrid and Rescue IABPs
Editor's Note The Food & Drug Administration on November 2 identified the recall by Maquet Datascope Corp/Getinge Group’s Cardiosave Hybrid and Cardiosave Rescue Intra-aortic Balloon Pumps (IABPs) as Class I, the most serious. The recall was initiated because of the potential for the autofill process to malfunction or fail during…
FDA: Class I recall of CyPass Micro-Stent Systems
Editor's Note The Food & Drug Administration (FDA) on October 24 classified Alcon Research’s recall of its CyPass Micro-Stent Systems as Class I, the most serious. The recall was initiated because of the risk of corneal endothelial cell loss with the system, which is used in conjunction with cataract surgery…
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