FDA Device recall Z-2402-2021
Pipeline Flex Embolization Device
- FDA Device
- Class I
- ongoing
- Published 2021-09-15
On 2021-09-15 the FDA classified a Class I recall of Pipeline Flex Embolization Device 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-2402-2021 |
| 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
Pipeline Flex Embolization Device
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: PED-250-10 PIPELINE FLEX 2.50MM X 10MM PED-250-10 00847536014343 Lot Numbers: A815698 A835648 A8…Product/REF/UDI: PED-250-10 PIPELINE FLEX 2.50MM X 10MM PED-250-10 00847536014343 Lot Numbers: A815698 A835648 A837027 A837028 A856681 A867213 A877526 A879720 A885865 A887304 A889034 A894160 A898559 A910394 A911797 A915537 Product/REF/UDI: PED-250-12 PIPELINE FLEX 2.50MM X 12MM PED-250-12 00847536014374 A813321 A819204 A822948 A848725 A876747 A879721 A887306 A887308 A887311 A887311 A887314 A887314 A894161 A894162 A894163 A904254 A908288 B005860 B017059 Product/REF/UDI: PED-250-14 PIPELINE FLEX 2.50MM X 14MM PED-250-14 00847536014404 Lot Numbers: A813323 A822948 A839880 A854063 A859756 A879723 A879724 A889035 A889037 A902102 A906073 A914143 A915539 Product/REF/UDI: PED-250-16 PIPELINE FLEX 2.50MM X 16MM PED-250-16 00847536014435 Lot Numbers: A822949 A829045 A843379 A882136 A887316 A889039 A894609 A909355 B005846 Product/REF/UDI: PED-250-18 PIPELINE FLEX 2.50MM X 18MM PED-250-18 00847536014466 Lot Numbers: |
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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-2402-2021%22
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