-Pipeline Embolization Device -Pipeline Flex Embolization Device The… — Class II medical device recall Z-0120-2016
Terminated recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, reported 2015-10-21, distributed in IL, KY, MD, MO, OR, TN, UT, VA…. The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped
| Recall number | Z-0120-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA, United States |
| Recall initiated | 2015-09-04 |
| Classified | 2015-10-14 |
| Reported by FDA | 2015-10-21 |
| Terminated | 2017-05-18 |
| Distributed | IL, KY, MD, MO, OR, TN, UT, VA, WI |
| Quantity | 23 devices |
| Lot numbers | 9724629, 9971250, 9977371, A011629, A012039, A012383, A012865, A012885, A013028, A013029, A013596, A024213, A024276, A026942, A029223, A029315, A029316, A031361, A047151, FA-77250-16V06, FA-77350-16V10, FA-77350-16V12, FA-77350-18VL0, FA-77350-20V12, FA-77375-14V12, FA-77375-16VL2, FA-77375-18V10, FA-77375-20VL2, FA-77400-14V12, FA-77425-18V12, FA-77450-14V12, FA-77475-20VL2, FA-77500-16VL2, PED-375-18V01, PED-400-20VO1, PED-475-20V01 |
| Model numbers | 9724629, 9971250, 9977371, A011629, A012039, A012383, A012865, A012885, A013028, A013029, A013596, A024213, A024276, A026942, A029223, A029315, A029316, A031361, A047151, FA-77250-16V06, FA-77350-16V10, FA-77350-16V12, FA-77350-18VL0, FA-77350-20V12, FA-77375-14V12 and 11 more |
Product
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based delivery system. The Pipeline and Pipeline Flex embolization device implant is a braided, multi-alloy, mesh cylinder woven from platinum/tungsten and cobalt-chromium-nickel alloy wires. The Pipeline and Pipeline Flex Embolization Devices are indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments.
Reason for recall
The firm is recalling Pipeline and Pipeline Flex Embolization Devices from U.S. since the devices were shipped with an EU version of the Instructions for Use.
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-0120-2016. 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.