Label provides new information about the size of the risk of PML, rates of PML according to number of infusions, and the association of risk with other drugs that suppress immune system.
Consumer Information on: Valiant & #xae; Thoracic Stent Graft with the Captiva Delivery System - P100040April 20, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments
The Valiant® Thoracic Stent Graft with the Captivia Delivery System is an endovascular stent graft2 and is used to repair fusiform aneurysms or saccular aneurysms/penetrating ulcers of the aorta3 in the chest. The Valiant® Thoracic Stent Graft is made...
Labeling, Approval Order, and Summary of Safety and Effectiveness for Valiant® Thoracic Stent Graft with the Captiva Delivery System (P100040).
Labeling, Approval Order, and Summary of Safety and Effectiveness for Pipeline? Embolization Device (P100018).
Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data. An MDDS does not modify the data or modify the display of the data, and it does not by itself control the...
Steris System 1 Processor: 6 Month Extension for Healthcare Facilities To Transition to Legally-Marketed AlternativesApril 19, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments
FDA has extended the transition period to February 2, 2012. All healthcare facilities must be transitioned from Steris Corporation?s modified System 1 processor (SS1) to legally-marketed alternative devices by that time.
Recommendations from the Medicare Payment Advisory Commission (MedPAC) could curtail use of medical imaging devices.
Manufacturers commenting on an FDA draft guidance addressing electronic data from clinical trials say the guidance is out of sync with current capabilities and practices for data capture and lacks information about the sponsor’s role in reviewing data.
Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding TubesApril 15, 2011 6:30 am | by U.S. Food & Drug Administration | News | Comments
Tablets may not fully disintegrate when water is added, and/or they may disintegrate but later form clumps which can adhere to the inside walls of oral syringes and feeding tubes.
Two lots of topiramate 100mg tablets recalled, reports of temporary gastrointestinal symptoms.
Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young AdultsApril 14, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments
FDA continues to receive reports of a rare cancer of white blood cells.
Premature detachment of the coil may cause the coil to unintentionally migrate. This can lead to serious injury including blood clots and stroke.
Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of TungstenApril 13, 2011 2:30 pm | by U.S. Food & Drug Administration | News | Comments
After use for IORT in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans.
FDA continues to receive reports of methemoglobinemia, a serious and potentially fatal adverse effect, associated with benzocaine products.
Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse ReactionsApril 6, 2011 7:30 am | by U.S. Food & Drug Administration | News | Comments
The most common severe reactions include enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy.
Products marketed as dietary supplements contain undeclared analogue of sildenafil, a drug which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 RecallApril 1, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
Small particles (debris) may be found inside the catheter and potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and organs which can result in serious injury and /or death.
Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient AdhesiveApril 1, 2011 4:30 am | by U.S. Food & Drug Administration | News | Comments
The deployment tube may detach during use and may result in the failure of the product to operate, This may cause serious injury and/or death.
The InterStim® Therapy System is a surgically implanted device used to help a patient reduce the number of bowel accidents (fecal incontinence)2. The InterStim® Therapy System has several components: a neurostimulator which delivers an electrical pulse...
Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama HospitalsMarch 30, 2011 11:30 am | by U.S. Food & Drug Administration | News | Comments
Use of contaminated products may lead to bacterial infection of the blood.
Products marketed as dietary supplement contain drug ingredients sulfosildenafil or tadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and DMarch 29, 2011 4:31 am | by U.S. Food & Drug Administration | News | Comments
Reports of consumers experiencing decreased renal function, elevated levels of calcium in the blood, fatigue, heart arrhythmia, vomiting, and diarrhea.
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test SystemMarch 23, 2011 8:30 am | by U.S. Food & Drug Administration | News | Comments
This document was developed as a special controls guidance to support the classification of ovarian adnexal mass assessment score test system into class II (special controls). An ovarian adnexal mass assessment score test system measures one or more...
The objective of this public meeting is to present the CDRH FY 2010 Priorities. In addition, FDA is interested in engaging in discussions about issues that are of importance to the medical device community. CDRH wishes to obtain feedback/ideas for...
Manufacturers and importers of all devices must continue to submit malfunction reports as they await a promised easing of requirements for Class I devices and Class II devices that are not permanently implantable, life supporting or life sustaining.