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 to retain their shape. Medtronic has received 41 complaints, including three injuries linked to perforation. No deaths have been reported, but undetected perforations of cardiac tissue carry a potentially fatal risk. Facilities are instructed to quarantine and destroy affected kits and submit a response form for credit.

Boston Scientific issued a July 24 notice, updated on September 12, regarding its ENDOTAK RELIANCE defibrillation leads with ePTFE-coated coils. The FDA classified this as its most serious type of recall. Coil calcification and tissue ingrowth can raise impedance and prevent defibrillation shocks from restoring normal rhythm. The company has documented 386 serious injuries and 16 deaths. Providers are directed to monitor impedance, program devices to maximize shock delivery, and consider replacing leads exceeding 150 ohms while weighing the risks of lead extraction.

Philips Respironics on June 6 recalled certain DreamStation Auto CPAP and BiPAP devices after programming errors were identified during supplier rework. Devices may deliver incorrect therapy modes or fail to provide proper pressure, leading to ineffective sleep apnea treatment and risks such as hypoventilation and disrupted sleep. Three injuries have been reported, and Philips is shipping replacements with return instructions.

Alongside these recalls, new product approvals have expanded available options for perioperative and critical care teams, Modern Healthcare September 11 reports. The FDA has cleared several devices, including Philips IntelliVue 6100, 6300, and 6500 patient monitors designed for high-acuity settings, and Restor3d’s Kinos Total Ankle System for patients with severe arthritis. Microbot Medical received clearance for its Liberty robotic system, a single-use platform for peripheral vascular procedures that allows operators to control devices from a safer distance. Additional approvals include Prytime’s pREBOA-PRO catheter for precise vessel occlusion, SutureTech’s RapidFix tendon repair device, and InTRAvent’s Solopass 2.0 navigation system for external ventricular drain placement.