FDA Device recall Z-2403-2021
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
- FDA Device
- Class I
- ongoing
- Published 2021-09-15
On 2021-09-15 the FDA classified a Class I recall of EV3 Pipeline Flex Embolization Device with Flex Shield Technology by Micro Therapeutics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2403-2021 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2021-07-13 |
| Published | 2021-09-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Micro Therapeutics |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV |
Product
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
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.
Identifiers
| code_info | Product/REF/UDI: PED2-250-10 PIPELINE FLEX SHIELD PED2-250-10 00847536002029 Lot Numbers: A816342 A827596 A834390…Product/REF/UDI: PED2-250-10 PIPELINE FLEX SHIELD PED2-250-10 00847536002029 Lot Numbers: A816342 A827596 A834390 A849720 Product/REF/UDI: PED2-250-14 PIPELINE FLEX SHIELD PED2-250-14 00847536002043 Lot Numbers: A812725 A832008 A833123 A846924 Product/REF/UDI: PED2-250-16 PIPELINE FLEX SHIELD PED2-250-16 00847536002050 Lot Numbers: A816342 A826273 A827599 A832010 A842690 A846927 Product/REF/UDI: PED2-250-20 PIPELINE FLEX SHIELD PED2-250-20 00847536002074 Lot Numbers: A810946 A816343 A816343 A819116 Product/REF/UDI: PED2-275-12 PIPELINE FLEX SHIELD PED2-275-12 00847536002098 Lot Number: A916293 Product/REF/UDI: PED2-275-14 PIPELINE FLEX SHIELD PED2-275-14 00847536002104 Lot Numbers: A830303 A830304 A846930 A846931 Product/REF/UDI: PED2-275-16 PIPELINE FLEX SHIELD PED2-275-16 00847536002111 Lot Numbers: A819135 A846932 A855391 A859750 A869908 A871955 A873194 Product/REF/UDI: PED2-275-18 PIPELINE FLEX SHIELD PED2-275-18 008 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2403-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.