FDA MedWatch - ZOOM 71 Reperfusion Catheter by Imperative Care:

Class I Recall - Due to Risk of Breaks During Use

If your email program has trouble displaying this email, view as a webpage. MedWatch - The FDA Safety Information and Adverse Event Reporting Program TOPIC:  ZOOM 71 Reperfusion Catheter by Imperative Care: Class I Recall - Due to Risk of Breaks During Use AUDIENCE: Patient, Health Professional, Risk Manager, Neurology ISSUE: Imperative Care is recalling specific lots of this product due to increased risk of the Zoom 71 Reperfusion Catheter breaking at a certain point (distal tip) during use, such as when the catheter is retracted forcefully. If the device breaks during use, this could lead to fractured pieces left inside the patient's bloodstream resulting in serious adverse events such as blockage of blood vessels, stroke, and death. There have been nine reports of serious injuries. There have been no deaths reported. For more information about this recall, click on the red button "Read Recall" below. BACKGROUND: The ZOOM 71 Reperfusion Catheter is used with the ZOOM Aspiration Tubing and ZOOM Aspiration Pump (or equivalent vacuum pump) to remove blood clots in the brain of a patient within eight hours of an acute ischemic stroke caused by blocked or narrowed arteries. RECOMMENDATIONS: On August 18, 2021, Imperative Care sent an "Urgent: Voluntary Medical Device Recall" letter to customers. The letter requested medical staff to: Share the recall notification with all users of the product within the facility to ensure they are also aware of the recall. Immediately review the inventory for the specific lot numbers listed in the letter. Remove and quarantine all unused affected products in the inventory. Return the affected products to Imperative Care. Your local Imperative Care Sales Representative can assist in facilitating the return of product as necessary. If a replacement product is needed, your local Imperative Care Sales Representative will be able to assist with identifying a suitable replacement product. Complete the Customer Confirmation Certificate attached to the "Urgent: Voluntary Medical Device Recall" letter and contact your local Imperative Care Sales Representative. Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online. Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Manage Subscriptions  |  Unsubscribe All  |  Help

This email was sent to edwardlorilla1986.paxforex@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA