Recall Z-2403-2021 ยท OUT Intracranial Aneurysm Flow Diverter
Micro Therapeutics Inc,
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
| Date | Jul 13, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Device Design |
| 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 Re |
| Quantity | 16,169 total devices for all model/products |
| Distribution | 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, Be |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.