FDA: Class I recall of Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter
Editor's Note The Food & Drug Administration on June 18 identified the recall by Cook Incorporated (Bloomington, Indiana) of its Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6 mm x 4 cm as Class I, the most serious. The recall was initiated because of multiple complaints of balloons bursting below…
FDA panel recommends reclassification of surgical staplers to Class II
Editor's Note The Food & Drug Administration’s General and Plastic Surgery Devices Advisory Committee on May 30 recommended that surgical staplers be reclassified from Class I to Class II devices. This would add premarket review and special controls to the devices. The Committee said Class II regulation would offer a…
FDA: Class I recall of SOLOPATH Balloon Expandable TransFemoral System, Re-Collapsible Balloon Access System
Editor's Note The Food & Drug Administration on May 30 identified the recall by Terumo Medical Corporation (Somerset, New Jersey) of its SOLOPATH Balloon Expandable TransFemoral System and Re-Collapsible Balloon Access System as Class I, the most serious. The recall was initiated because the tip could dislodge from the outer…
FDA: Heritage Pharmaceuticals recalls Amikacin Sufate Injection, Prochlorperazine Edisylate Injection
Editor's Note The Food & Drug Administration (FDA) on May 28 announced the recall by Heritage Pharmaceuticals Inc (East Brunswick, New Jersey) of Amikacin Sulfate Injection, USP 1 gm/4 mL (250 mg/mL), Lot: VEAC025, Expiry Date: October 2019; and Prochlorperazine Edisylate Injection, USP 10 mg/2 mL (5 mg/mL), Lot: VPCA172,…
FDA: Class I recall of Integra LifeSciences CSF drainage, ICP monitoring systems
Editor's Note The Food & Drug Administration on May 24 identified the recall by Integra LifeSciences of its LimiTorr Volume Limiting Cerebrospinal Fluid (CSF) Drainage System and the MoniTorr Intracranial Pressure (ICP) External CSF Drainage and Monitoring System as Class I, the most serious. The recall was initiated because of…
FDA grants Stryker premarket approval for intracranial aneurysm stent
Editor's Note Stryker announced on May 20 that the Food & Drug Administration (FDA) granted premarket approval for its Neuroform Atlas stent system for intracranial aneurysms, the May 20 MassDevice reports. The self-expanding nitinol stent can now be used with neurovascular embolization coils to treat patients with saccular wide-necked…
FDA letter updates mortality risk in patients receiving Abiomed Impella RP System
Editor's Note The Food and Drug Administration (FDA) on May 21 released a letter to healthcare professionals about the most recent, interim post-approval study (PAS) results for the Abiomed Impella RP System, a percutaneous heart pump for right heart support. The latest interim results show a lower survival rate…
FDA issues warning on use of unauthorized devices for diabetes management
Editor's Note The Food & Drug Administration (FDA) on May 17 issued a warning to patients and healthcare professionals on the risks associated with the use of unapproved or unauthorized devices for diabetes management, including continuous glucose monitoring systems, insulin pumps, and automated insulin dosing systems. The use of these…
FDA: Class I recall of Ethicon circular staplers
Editor's Note The Food and Drug Administration (FDA) on May 16 identified the recall by Ethicon of its Endo-Surgery and Endo-Surgery Endoscopic Curved Intraluminal Staplers with adjustable height staples as Class I, the most serious. The recall was initiated because Ethicon confirmed that uncut washers in the staplers and malformed…
FDA issues alert on premature battery depletion in certain Medtronic pacemakers
Editor's Note The Food & Drug Administration (FDA) on May 7 issued a Safety Alert on the risk for premature battery depletion in nearly 132,000 biventricular and conventional cardiac resynchronization therapy implantable pacemakers by Medtronic. The FDA is aware of three patients in which a battery fully drained because of…
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