Micrus Endovascular Microcoil Delivery System; The Micrus Microcoil Delivery System consists of three components, a Micr

FDA device recall Z-0845-2011 · posted 2011-01-03 · Terminated

Recall details

Recalling firm

Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131

Reason for recall

The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm.

Action taken

Micrus Endovascular Corp sent Urgent: Medical Device Recall Letters dated October 21, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine inventory (including consignment) and quarantine the product to prevent it from being used or shipped. If the product was further distributed, customers were to notify their customers by sending a copy of the recall letter and were instructed to work with all customers to ensure that all product was returned and that pre-use protocol was followed. The response form was to be completed and returned indicating the number of devices that had been used (or shipped if distributor) and the number that would be returned. Customers were to call the Micrus Customer Service Department at 1-888-550-4129 from 8:00 am to 5:00 Pacific time for arrange for a Return Authorization number and replacement. Recall letters also stressed the importance of always following the pre-use protocol and inspecting the device immediately prior to use. Additionally, connector functionality should be verified and instructions were provided. Questions or concerns should be directed to Micrus Customer Service at 1-888-4120. Consignees who did not respond to the initial recall notification after 15 days were notified again by letter. A third letter was sent after another 15 days if there was still no response.

Root cause

Other

Status

Terminated

Product code

HCG

Quantity affected

6755

Distribution

Worldwide Distribution - USA including AK, AL, AZ, CA, CO, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries

Date initiated

2010-10-21

Date posted

2011-01-03

Date terminated

2011-01-11

Location

San Jose, CA

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