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Latest Medical Device News

• Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System - Product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure.
• Byetta (exenatide) - UPDATE - Since October 2007, FDA has received reports of 6 cases of hemorrhagic or necrotizing pancreatitis in patients in taking Byetta.
• Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) - UPDATE - Dear Healthcare Professional letter added.
• Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia) - Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer.
• Fentanyl Transdermal System CII Patches - UPDATE - Voluntary recall because one lot of the product contained patches leaking fentanyl gel.
• July 2008 Monthly Safety Labeling - Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
• Pacific Consolidated brand Mobile Oxygen Storage Tank - Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing.
• September 2008 Patient Safety News - Video news show for healthcare professionals, covering safety alerts, recalls, product approvals, and important tips on protecting patients.
• Tumor necrosis factor-α blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) - Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers.
• Tysabri (natalizumab) - Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year.
• Vivitrol (naltrexone) - Serious injection site reactions may occur with the use of injectable naltrexone.

Archive for October, 2007

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