FDA flags device recalls while clearing new technologies for surgery, critical care
Editor's Note The Food and Drug Administration (FDA) has issued multiple high-risk medical device recalls in recent weeks, mid-September FDA announcements report. On August 21, Medline alerted customers that some of its convenience kits contain recalled Medtronic DLP Left Heart Vent Catheters. These catheters, used in cardiopulmonary bypass, may fail…
ACS issues new best practices for managing genitourinary trauma
Editor's Note The American College of Surgeons (ACS) has released updated Best Practices Guidelines for the Management of Genitourinary Injuries, providing trauma teams with evidence-based recommendations to improve outcomes for patients with injuries to the kidneys, bladder, ureters, urethra, and genitalia. According to an ACS August 26 news release, the…
FDA issues early alerts on multiple high-risk device recalls from J&J, Medtronic, Baxter, Boston Scientific
Editor's Note The Food and Drug Administration (FDA) has issued a series of early alerts this month regarding high-risk recalls from several leading medical device makers, citing patient safety risks ranging from pump failures to vascular complications. These alerts highlight issues with products from Johnson & Johnson’s (J&J’s) Abiomed unit,…
Pilot study suggests robotic force feedback may reduce tissue trauma in colorectal surgery
Editor's Note Early findings indicate the da Vinci 5 (DV5) platform’s force feedback technology can reduce the amount of force surgeons apply to tissue, potentially minimizing trauma during colorectal surgery. According to a pilot study published in the American Journal of Surgery on July 10, the feature allows surgeons to…
2026 ICD-10 updates bring hundreds of new codes, new complexity
Editor's Note Healthcare providers, payers, and analytics teams face sweeping ICD-10 changes this fall, with the 2026 code updates taking effect October 1, 2025, Wolters Kluwer July 14 reports. The release includes 614 new codes, 12 invalidations, 642 billability changes, 88 terminology revisions, and the creation of an entirely new…
UC Davis secures $2M to study bone health in prostate cancer, prevent post-injury arthritis
Editor's Note The UC Davis Department of Orthopaedic Surgery has received more than $2.2 million in Department of Defense funding for two research projects addressing bone health in prostate cancer and preventing arthritis after joint injuries, a UC Davis Health July 15 news release reports. The larger grant, $1.8 million,…
FDA safety alerts flag cardiac devices
Editor's Note The US Food and Drug Administration (FDA) issued early alerts August 6 for three medical devices due to safety concerns: Medline ReNewal’s reprocessed St. Jude Medical electrophysiology catheters, Boston Scientific’s ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils, and Boston Scientific's WATCHMAN Access Systems. The Medline alert involves specific lots…
FDA issues Class I recall for Philips BiPAP ventilators
Editor's Note Philips Respironics BiPAP A30, A40, and V30 Auto ventilators are subject to a Class 1 recall—the US Food and Drug Administration’s (FDA’s) most severe category indicating risk of serious injury or death—due to the risk for a failure in the Ventilator Inoperative alarm, which can cause therapy interruption…
FDA designates Class I recall for arterial cannulae due to exposed wire risk
Editor's Note The US Food and Drug Administration (FDA) has designated a Class I recall—the most severe category indicating risk of serious injury or death—for several models of arterial cannulae manufactured by Edwards Lifesciences. Affected products include OptiSite Arterial Perfusion Cannula models OPTI16 and OPTI18, as well as Peripheral Femoral…
FDA designates Class I recall for mobile lift component
Editor's Note The US Food and Drug Administration (FDA) has designated Baxter’s recall of the Q-Link 13 mobile lift component a Class I, the most severe category indicating risk of serious injury or death. As detailed in the agency’s July 23 announcement, the optional component connects to sling bars on…
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