EV3 Pipeline Flex Embolization Device with Flex Shield Technology — Class I medical device recall Z-2403-2021
Ongoing recall by Micro Therapeutics Inc,, reported 2021-09-15, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in th
| Recall number | Z-2403-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics Inc,, Irvine, CA, United States |
| Recall initiated | 2021-07-13 |
| Classified | 2021-09-03 |
| Reported by FDA | 2021-09-15 |
| Distributed | 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 |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, ID, IE, IL, IN, IT, JO, JP, KR, LB, LV, MX, MY, NL, NO, NZ, PE, PK, PL, QA, RS, SA, SE, SG, SK, TH, TN, TR, TW, VN, ZA |
| Quantity | 16,169 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00847536002029, 00847536002043, 00847536002050, 00847536002074, 00847536002098, 00847536002104, 00847536002111, 00847536002128, 00847536002135, 00847536002142, 00847536002159, 00847536002166, 00847536002173, 00847536002180, 00847536002197, 00847536002203, 00847536002227, 00847536002234, 00847536002241, 00847536002258, 00847536002272, 00847536002289, 00847536002296, 00847536002302, 00847536002319 and 60 more |
| Lot numbers | A810946, A811477, A811479, A811480, A812095, A812725, A812726, A812727, A812728, A812729, A812730, A812731, A812732, A812733, A812734, A813318, A813319, A813320, A815075, A815076, A815077, A815078, A815079, A815080, A815691, A815692, A815693, A815694, A815695, A815696, A815697, A816342, A816343, A816345, A816346, A816347, A816348, A817107, A817108, A817109 and 460 more |
Product
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2403-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.