ev3 Pipeline Flex Embolization Device with Shield Technology — Class I medical device recall Z-1528-2020
Terminated recall by Micro Therapeutics Inc, Dba Ev3 Neurovascular, reported 2020-04-01, distributed nationwide. Embolization device delivery system may fracture at the distal section during device implantation. A weakened
| Recall number | Z-1528-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics Inc, Dba Ev3 Neurovascular, Irvine, CA, United States |
| Recall initiated | 2020-02-14 |
| Classified | 2020-03-25 |
| Reported by FDA | 2020-04-01 |
| Terminated | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BG, BR, CA, CH, CN, CO, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, IN, IT, JO, JP, KR, LB, MX, NL, NO, PL, PY, QA, RS, SA, SE, SK, TR, TW, UY, VN |
| Quantity | 762 |
| Reason classes | device malfunction |
| Lot numbers | A918616, A918617, A918618, A918619, A918620, A918621, A918622, A918623, A918624, A918625, A918626, A918628, A918665, A918667, A918668, A920902, A922597, A922598, A922599, A922600, A922601, A922687, A922688, A922690, A922691, A922692, A922693, A922694, A922695, A922697, A922698, A922699, A925289, A925290, A925291, A925292, A925293, A925295, A925296, A925297 and 283 more |
Product
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
Reason for recall
Embolization device delivery system may fracture at the distal section during device implantation. A weakened bond may result in unintended separation, where the distal portion of the device delivery system remains in the patient. If a Pipeline Flex embolization device has already been implanted successfully, there is no increased risk to patients due to this issue.
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-1528-2020. 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.