Class I recalls
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Recalling Manufacturer, Date Posted, Trade Name/Product, Reason for Recall
Minneapolis-based InterValve Inc. won FDA clearance for its V8 aortic valvuloplasty balloon catheter, which features a "figure-8" shape that helps lock the device in place in the aorta, the company announced.
The FDA okay-ed the device for stand-alone balloon aortic valvuloplasty as well as for pre-dilation during transcatheter aortic valve implantation procedures, according to a press release.
NxStage Medical (NSDQ:NXTM) touted FDA clearance for high flow capabilities for the company’s System One home hemodialysis technology, a device the company calls the "only truly portable hemodialysis system cleared for home use."
The Lawrence, Mass.-based medical device maker plans to launch new higher flow System One devices later this year, according to a press release.
European regulators granted market approval to St. Jude Medical (NYSE:STJ) for its Allure Quadra quadripolar cardiac resynchronization therapy pacemaker, the medical device giant announced this week.
The FDA cleared a technique called analogous fat transfer for Andrew Technologies’ HydraSolve liposuction procedure.
The technique allows surgeons to reinject a patient’s own fat, gathered during the HydraSolve liposuction procedure.
HydraSolve uses a saline solution to liquefy fat tissue, a process called disaggregation. Analogous fat transfer maintains that fat tissue for injection into different parts of the body.
Microline Surgical said it won 510(k) clearance from the FDA for the flexible ligating shears it designed for TransEnterix’s Spider surgical platform.
Beverly, Mass.-based Microline said the shears are based on its MiFusion DC resistive direct thermal fusion technology.
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NinePoint Medical won an expanded FDA nod for its NvisionLVE system, which can now be used for esophageal imaging procedures.
The Cambridge, Mass.-based medical device company won FDA clearance in January 2012 for an indication to evaluate human tissue microstructure.
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Lantos Technologies said the FDA granted 510(k) clearance for its 3D ear canal imaging device, designed to enhance the design of customized hearing aids.
Initially developed at the Mass. Institute of Technology, the Lantos device uses ultrasound to create a 3D image of the ear canal and is designed to obviate the need for siliconm molding of the canal.
Teleflex (NYSE:TFX) said its ultrasound device, the Arrow VPS G4, will be available in the U.S. in the 2nd quarter this year.
The FDA cleared the device for use in conjunction with Teleflex’s disposable Arrow VPS Stylet.
The new Arrow device uses micro-doppler ultrasound and intravascular electrocardiography to locate a specific location of the vena cava and cavo-atrial junction. Finding this small location in the heart is important when placing a peripherally inserted central catheter.
By Sony Salzman
Federal regulators cleared ResMed‘s (NYSE:RMD) variable positive airway pressure device for at-home use for patients with chronic obstructive pulmonary disease.
The VPAP device, used at night to prevent acute respiratory exacerbations, was built on San Diego-based ResMed’s S9 platform, according to a press release.