FDA Issues Class I Recall for Boston Scientific Carotid Stent
What Happened: Scope & Rationale On August 22, 2025, the FDA classified as Class I the recall of Boston Scientific’s Carotid WALLSTENT Monorail Endoprosthesis, a self-expanding stent used to treat carotid artery narrowing U.S. Food and Drug AdministrationCardiovascular Business. Affected models (over 26,000 globally, including 1,333 in the U.S.) were found to have a manufacturing […]
FDA Issues Import Alerts on Olympus Medical Devices Made in Japan
Background & Regulatory Action On June 24, 2025, the U.S. Food and Drug Administration (FDA) issued Import Alert 89-04, targeting certain Olympus medical devices manufactured at its Aizu facility in Fukushima, Japan. These include: The alert effectively blocks 58 specific models from entering the U.S., citing ongoing violations of Quality System regulations (QSR) despite Olympus’ […]
Blog: FDA Urges Strict Adherence to Safe Use of Hyperbaric Oxygen Therapy Devices
1. Context & Safety Warning On August 25, 2025, the FDA issued a Letter to Health Care Providers, reminding clinicians and facilities of the critical importance of following manufacturer instructions when using hyperbaric oxygen therapy (HBOT) devices—given rising reports of serious injuries and fatalities U.S. Food and Drug Administration. Key recommendations include: The FDA emphasized […]
Deep Brief — Medical Device User Fee Small Business Qualification & Determination (FDA guidance, July 31, 2025)
What it is, why it matters, and exactly what manufacturers — including regulatory, PV/PS (pharmacovigilance / product safety), quality and finance teams — must do Short version: This FDA guidance explains how device and biologics firms can qualify as a “small business” for reduced MDUFA user fees (and for a one-time waiver of a first […]
Philips Respironics BiPAP A30 / A40 / V30 — Continuous Ventilator Correction, Clinical Risks, and Manufacturer Action Plan
Source: FDA Medical Device Recalls page (updated Aug 6, 2025).Link reviewed: FDA recall notice for Philips Respironics update of use instructions for BiPAP A30, A40, and V30 due to interruptions and/or loss of therapy. U.S. Food and Drug Administration Executive summary Philips Respironics issued an urgent device correction for all lots of the BiPAP A30, […]
Early Alert: Boston Scientific ENDOTAK RELIANCE Defibrillation Leads — investigative report, clinical guidance, and manufacturer action plan
Source: FDA Early Alert (posted Aug 6, 2025). U.S. Food and Drug Administration Executive summary (two sentences) The FDA posted an Early Alert after Boston Scientific notified clinicians that certain ENDOTAK RELIANCE defibrillation leads with ePTFE-coated shock coils are showing coil calcification that correlates with a gradual rise in low-voltage shock impedance (LVSI) and can […]
Early Alert: Medline ReNewal Reprocessed EP Catheters with Residual Particulates – What You Need to Know
Date of FDA Page Update: August 6, 2025 U.S. Food and Drug Administration The device and product details These catheters are used for electrophysiology (EP) mapping, stimulation, and recording in diagnosing and managing cardiac arrhythmias via endocardial and intravascular access. U.S. Food and Drug Administration Reason for the Early Alert Medline ReNewal found that affected […]
Max Mobility / Permobil Expands Worldwide Recall of SmartDrive SpeedControl Dial — Investigative report and manufacturer action plan
Published: August 12, 2025Source: Company announcement posted on FDA recalls page. U.S. Food and Drug Administration Executive summary (quick take) Max Mobility / Permobil has announced a voluntary, worldwide expanded recall and market removal of all SpeedControl Dials used with the SmartDrive MX2+ power-assist device. The action covers every SpeedControl Dial manufactured and distributed between […]
Regulation on Medical Device in India (Medical devices rules, 2017)
Ministry of health and family welfare on 31st January 2017 published the guidance regarding Medical devices. Regulation of Medical Device Classification of Medical devices: Classification of medical devices.— (1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis of parameters specified in Part I of the First Schedule, in […]