FDA: Class I recall of Ethicon circular staplers
Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious. The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed…
FDA issues alert on premature battery depletion in certain Medtronic pacemakers
Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…
FDA: Class I recall of Neuro Omega System
Editor's Note The Food and Drug Administration (FDA) on May 6 identified the recall my Alpha Omega Engineering of its Neuro Omega System, including the Drive Headstage unit, as Class I, the most serious. The recall was initiated because a design flaw in the device may connect two separate electrode…
FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters
Editor's Note The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious. The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or…
FDA issues draft guidance on initiating voluntary recalls
Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls. The guidance includes recommendations in three areas: proper training of personnel thorough and organized record keeping written recall initiation procedures. The guidance…
FDA announces new efforts to protect patients from risks associated with surgical staplers, implantable staples
Editor's Note The Food & Drug Administration on April 23 announced new steps it will be taking to help reduce risks associated with surgical staplers for internal use and implantable staples. The proposed steps include: Reclassifying surgical staplers from Class I (low risk) to Class II (moderate risk). Issuing guidance to…
FDA orders manufacturers to stop selling gynecologic mesh
Editor's Note The Food and Drug Administration (FDA) on April 16 announced that it had ordered manufacturers of surgical mesh products indicated for transvaginal repair of pelvic organ prolapse to stop selling and distributing their products in the US, immediately. The FDA has determined that manufacturers, Boston Scientific and Coloplast,…
FDA: Class I recall of Brainlab Spine & Trauma 3D Navigation Software
Editor's Note The Food & Drug Administration (FDA) on April 15 identified the recall of Brainlab's Spine & Trauma 3D Navigation Software as Class I, the most serious. The Software is being recalled because of the potential for incorrect information to display during surgery, which may prevent the surgeon from…
FDA issues Safety Communication on cybersecurity vulnerabilities in Medtronic cardiac devices
Editor's Note The Food & Drug Administration on March 21 issued a Safety Communication on cybersecurity vulnerabilities identified in wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. Medtronic (Dublin, Ireland) is working on updates to address the vulnerabilities and recommends that healthcare…
FDA issues warning letters to two breast implant manufacturers
Editor's Note The Food & Drug Administration (FDA) on March 19 issued warning letters to two breast implant manufacturers (Mentor Worldwide LLC of Irvine, California, and Sientra, Inc of Santa Barbara, California) for failing to comply with post-approval study requirements. All manufacturers of approved silicone gel-filled implants are required to…
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