Open, Classified

EV3 Pipeline Flex Embolization Device with Flex Shield Technology

FDA Recall Z-2403-2021 · Posted None

Recall StatusOpen, Classified

Product CodeOUT

Date Initiated2021-07-13

Product Quantity16,169 total devices for all model/products

Reason for Recall

Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

Firm Action

On 07/13/2021, the firm sent via mail courier service an "URGENT: MEDICAL DEVICE RECALL" Notification letter to customer informing them they have received reports of serious injuries and deaths in connection with delivery pushwire fracture at the distal section of the delivery system during use. This recall affects all models of the embolization devices manufactured between April - October 2019, and April - May 2020. Customers are instructed to: 1. Do NOT use any impacted product. Remove and quarantine all unused impacted products in their inventory. 2. Return the impacted products to the Recalling Firm. Their Recalling Firm representative can assist in facilitating the return of product as necessary. If alternative product is needed, their Recalling Firm representative can assist them with identifying suitable replacement product. 3. Complete the attached Customer Confirmation Form, see Attachment 2, and fax it to 1-651-367-7075 to the attention of Neurovascular Quality or email it to [email protected]. 4. Share this communication within their organization, with other organizations where impacted devices may have been transferred, and any other associated organizations that may be impacted by this action. For additional questions and/or assistance, contact the Recalling Firm's Representative or email the Office of Medical Affairs at [email protected].

Root Cause

Device Design

Distribution Pattern

U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV O.U.S.: Argentina, Brazil Canada, Chile, Colombia, Ecuador, Mexico, Peru, Austria, Belgium, Canary Island, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Kazakhstan, Latvia, Macedonia, Netherlands, Norway, Poland, Russian Federation, Serbia, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, Brunei Darussalam, Egypt, Israel, Jordan, Lebanon, Qatar, Saudi Arabia, Syrian Arab Republic, United Arab Emirates, South Africa, Tunisia, Reunion, China, Hong Kong, Macao, Singapore, Taiwan, Australia, New Zealand, Bangladesh, India, Pakistan, Indonesia, Malaysia, Thailand, Vietnam, Japan, and Republic of Korea.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.