Pipeline Flex Embolization Device — Class I medical device recall Z-2402-2021
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-2402-2021 |
|---|---|
| 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 | 00847536014343, 00847536014374, 00847536014404, 00847536014435, 00847536014466, 00847536014497, 00847536014527, 00847536014558, 00847536014589, 00847536014619, 00847536014640, 00847536014671, 00847536014701, 00847536014732, 00847536014763, 00847536014794, 00847536014824, 00847536014855, 00847536014886, 00847536014916, 00847536014947, 00847536014978, 00847536015005, 00847536015036, 00847536015067 and 67 more |
| Lot numbers | A810945, A811477, A812097, A812119, A812724, A813323, A813324, A813325, A813326, A813327, A813329, A813907, A813908, A813909, A813912, A813913, A813915, A813916, A813917, A815062, A815063, A815064, A815065, A815066, A815067, A815068, A815069, A815071, A815073, A815074, A815698, A815699, A815702, A816329, A816330, A816334, A816335, A816341, A817117, A817119 and 460 more |
Product
Pipeline Flex Embolization Device
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-2402-2021. 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.