Devices
Becton Dickinson has recalled (Class 1 device correction) its BD Alaris Pump Module Model 8100 with Guardrails, Suite MX software versions, because the infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.
Devices
FDA has approved an Instylla PMA for its Embrace Hydrogel Embolic System (HES), a liquid embolic device for treating hypervascular tumors in peripheral arteries measuring 5 millimeters or less. Hypervascular tumors, which are commonly found in the liver, kidneys, bones, and other organs, are typically difficult to treat due to
Devices
A 2/24-2/27 FDA inspection at Visgeneer, Inc., in Hsinchu City, Taiwan, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of a glucose monitoring system and a blood uric acid monitoring system. A just-released 6/13 Warning Letter says the specific
Devices
FDA says the per- and polyfluoroalkyl substances (PFAS) used in medical devices are not the same as those identified as being potentially harmful to people in other contexts. An agency online post says the PFAS materials used in medical devices, known as fluoropolymers, have a long history of use. “FDA’
Devices
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The agency has set a user fee
Devices
FDA has issued an early alert based on a Boston Scientific letter to customers about certain Endotak Reliance defibrillation leads with expanded polytetrafluoroethylene (ePTFE) coated coils that may impact shock efficacy or require early replacement. The leads are intended for pacing, rate-sensing, and delivery of cardioversion and defibrillation shocks
Devices
FDA has issued an alert after Boston Scientific notified customers that all lots of certain Watchman Access Systems have updated use instructions to prevent air embolism events. The devices are intended to provide vascular and transseptal access for the family of Watchman FLX Left Atrial Appendage Closure Devices with Delivery
Devices
FDA says it is aware that Medline ReNewal has told affected customers that certain Medline ReNewal Reprocessed St. Jude Medical Response Diagnostic Electrophysiology Catheters and Supreme Electrophysiology Catheters should be removed from where they are sold or used. An agency Early Alert says Medline ReNewal stated that specific lots of
Devices
A 2/24-2/27 FDA inspection at the Mectronic Medicale S.R.L. facility in Bergamo, Italy, identified Quality System, Medical Device Reporting, and other violations in the firm’s illegal manufacturing of adulterated and misbranded laser medical devices. A just-released 6/27 Warning Letter says the firm
Devices
Philips Respironics is recalling (Class 1 device correction) its V30, A30, and A40 ventilators to update their use instructions due to the risk of failure involving the “Ventilator Inoperative” alarm, which can cause therapy interruption or loss. A recall notice says the devices may reboot intermittently, which could stop therapy,
Devices
Illumina has agreed to pay $9.8 million to settle allegations that it violated the False Claims Act by selling genomic sequencing systems with known cybersecurity vulnerabilities to U.S. government agencies. According to the Department of Justice (DoJ), between 2016 and 2023 Illumina allegedly sold sequencing systems to federal
Devices
Draeger has recalled (Class 1) its SafeStar 90 Plus bidirectional breathing system filter after receiving reports of slow increase of CO2-curve when a gas sample is taken from the filter’s sampling port, according to a recall notice. The filters are designed for infection prophylaxis during mechanical ventilation, particularly
Devices
Hamilton Medical has recalled (Class 1) its coaxial (1.8 m) breathing circuit set with flow sensor and expiratory valve that are used with HAMILTON-C1, HAMILTON-T1 and HAMILTON-MR1 ventilators. The breathing circuit may have a crack in its blue tubing, which is used to deliver fresh gas
Devices
FDA has approved SetPoint Medical’s SetPoint System, a first-of-its-kind neuroimmune modulation device to treat adults with moderate to severe rheumatoid arthritis who are not adequately managed by, or can’t tolerate, existing advanced therapies such as biological and targeted synthetic disease-modifying anti-rheumatic drugs. A
Devices
FDA has cleared a Cardiosense 510(k) for its CardioTag device, a wearable device capable of simultaneously capturing electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals. These signals are intended to offer clinicians a more complete picture of heart function, including insights into cardiac mechanics, blood flow, and hemodynamics, according
Devices
FDA has published a guidance, Medical Device User Fee Small Business Qualification and Determination, describing the process for how a business may request a determination that it qualifies as a small business for the purpose MDUFA provisions about reduced fees for such businesses. The document says that a business that
Devices
A 2/4-4/4 FDA inspection at Onkos Surgical in Parsippany, NJ, determined that the firm is a specification developer of the ELEOS Limb Salvage System, indicated for use in total knee and hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature
Devices
FDA has cleared a Stereotaxis 510(k) for its MAGiC Sweep catheter, which it describes as the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter for diagnosing and treating complex arrhythmia patients. “High density mapping has transformed the EP field, enhancing cardiac ablation procedures by enabling more
Devices
Ethicon Endo-Surgery is recalling (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the product’s inadvertent lockout during surgical procedures. The device will momentarily activate but will not cut or staple tissue, a recall notice says. “Additional steps will be required to open it and
Devices
Medline Industries is recalling (Class 1 device correction) certain lots of its Craniotomy Kits containing recalled Codman Disposable Perforators 14mm. Integra LifeSciences has recalled the perforators due to an inadequate weld that may cause the perforator to come apart before, during or after use in a craniotomy procedure, a recall
FDA Policy/General
Former and current FDA employees who have used the agency’s new internal generative artificial intelligence (AI) tool Elsa report that it can’t be trusted. An online Gizmodo post says three employees told CNN that Elsa makes up nonexistent studies, something commonly referred to in AI as “hallucinating.” The
Devices
Baxter Healthcare has recalled (Class 1) a mobile lift component used in several patient lift devices due to the risk of improper attachment. The company says that the Q-link 13 component could allow for false latching of the quick-release hook used on sling bars and other accessories. “The