Pipeline Embolization Device — Class II medical device recall Z-2045-2013
Terminated recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, reported 2013-09-04, distributed in AZ, CA, CO, FL, GA, IA, IL, KY…. Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because
| Recall number | Z-2045-2013 |
|---|---|
| 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 | 2013-07-19 |
| Classified | 2013-08-23 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2013-10-17 |
| Distributed | AZ, CA, CO, FL, GA, IA, IL, KY, MA, MO, NC, NV, NY, OR, TN, TX, UT, VA, WI |
| Quantity | 62 units |
| Lot numbers | 9743468, 9744123, 9744487, 9747602, 9747604, 9749412, 9750678, 9751579, 9752438, 9752785, 9752787, 9752788, 9753033, 9753034, 9755707, 9757024, 9757065, 9757068, 9757233, 9759088, 9759141, 9759560, 9768698, FA-71400-25, FA-71500-35, FA-77300-16, FA-77325-14, FA-77325-16, FA-77325-18, FA-77350-16, FA-77350-18, FA-77375-16, FA-77375-20, FA-77400-14, FA-77400-16, FA-77400-18, FA-77400-20, FA-77425-16, FA-77425-20, FA-77450-18 and 2 more |
Product
Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments.
Reason for recall
Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (PED) because the Instructions For Use (IFU) do not include the following contraindication: Patients in whom a pre-existing stent is in place in the parent artery at the target aneurysm location. Additionally, the designation of aspirin and clopidogrel was missing from the following contraindication "
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-2045-2013. 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.