![]() ![]() Learn more about medical device recalls.Ģ Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.ģ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Worldwide Distribution - US Nationwide in the state of: PA, FL, IN, MI, TN, AL, IL, KY, MI, TX, OH, MO, MA, MN, ID, AL, TN, VA, CA and internationally to Austria, Australia, Belgium, Switzerland, Germany, Great Britain, Greece, Hong Kong, Israel, Iran, Italy, Japan, Kuwait, Latvia, Malaysia, Netherlands, Saudi Arabia, Singapore, Thailand, and South Africa.ġ A record in this database is created when a firm initiates a correction or removal action. Customers were instructed to contact their local Sales Representative to answer any questions. The letter identified the affected products, problem and actions to be taken. ĭuring routine monitoring of complaints, BSC noted that the IntellaTip MiFi XP N4 complaint rate for distal tip bends/kinks was above the anticipated rate in BSC's product risk documentation.īoston Scientific sent an Urgent Medical Device Removal letters to all affected customers dated Novemvia Fed Ex or other equivalent service. The IntellaTip MiFi XP Catheter is indicated for interruption of accessory atrioventricular conduction pathways associated with tachycardia, for treatment of AV nodal reentrant tachycardia, for treatment of atrial flutter tachycardia, and for creation of complete AV block in patients with a rapid ventricular response to an atrial arrhythmia typically chronic, drug refractory atrial fibrillation. Cardioversion or defibrillation is also used in emergency situations for people who suffer sudden life-threatening arrhythmias. Material Number: M004EPM4500N40 Catalog number: EPM4500N4 Short of breath Dizzy or faint Cardioversion also treats other kinds of abnormal heartbeats, including atrial flutter, atrial tachycardia and ventricular tachycardia. Similarly, atrial flutter starts in the right atrium and prevents enough blood from being pumped to the lungs for oxygen. IntellaTip MiFi XP Asymmetric (N4) Curve, Viles-Gonzalez says that AFib occurs when the left upper chamber of the heart, or atrium, contracts irregularly and prevents the heart from pumping enough blood to the rest of the body. ![]() ![]() ( 29627355) The two most common scenarios are: (1) A patient with chronic AF develops critical illness. Class 2 Device Recall IntellaTip MiFi XP Asymmetric Curve Temperature Ablation CatheterĬatheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD Since AFib symptoms and discomforts can be so subjective, its not uncommon for AFib to be mistaken for these other health problems: Tachycardia and other. overall approach: agent selection for rate control: introduction (back to contents) what this chapter is about AF is the most common arrhythmia encountered in the ICU. ![]()
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