Medtronic Pipeline Vantage Embolization Device with Shield Technology — Class I medical device recall Z-1245-2025
Ongoing recall by Micro Therapeutics, Inc., reported 2025-03-12, distributed nationwide. Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition
| Recall number | Z-1245-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Micro Therapeutics, Inc., Irvine, CA, United States |
| Recall initiated | 2025-01-30 |
| Classified | 2025-03-05 |
| Reported by FDA | 2025-03-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IN, IS, IT, JO, KR, KW, LB, LT, LU, LV, MA, MX, MY, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, RS, RU, SA, SE, SG, SK, TH, TN, TR, TW, UA, UY, VN, ZA |
| Quantity | 18,245 |
| UPC / GTIN / UDI-DI | 00847536030770, 00847536030787, 00847536030794, 00847536030817, 00847536030824, 00847536030862, 00847536030879, 00847536030886, 00847536030909, 00847536030916, 00847536030923, 00847536030961, 00847536030978, 00847536030985, 00847536031005, 00847536031012, 00847536031029, 00847536031043, 00847536031067, 00847536031074, 00847536031098, 00847536031104, 00847536031111, 00847536031135, 00847536031166 and 77 more |
| Lot numbers | 00847536030770/B409106, 00847536030787/B409234, 00847536030794/B409692, 00847536030817/B410645, 00847536030824/B410718, 00847536036680/B321585, 00847536036697/B318079, 00847536036703/B326193, 00847536036727/B318459, 00847536036734/B322422, 00847536036741/B394830, 00847536036789/B322748, 00847536036796/B320465, 00847536036802/B318562, 00847536036826/B325710, 00847536036833/B319170, 00847536036840/B396144, 00847536036864/B353358, 00847536036895/B353371, 00847536036901/B320910, 00847536036925/B326325, 00847536036932/B354639, 00847536036949/B337320, 00847536036963/B319346, 00847536037007/B358321, 00847536037021/B412256, 00847536037045/B397247, 00847536037069/B358931, 00847536037083/B397414, 00847536037120/B368960, 00847536037144/B317266, 00847536037168/B339559, 00847536037182/B320318, 00847536037205/B327190, B328706, B328709, B329314, B329316, B330879, B330881 and 460 more |
| Model numbers | PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25 and 14 more |
Product
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PED3-027-400-14, PED3-027-400-16, PED3-027-400-18, PED3-027-400-20, PED3-027-400-25, PED3-027-400-30, PED3-027-450-12, PED3-027-450-14, PED3-027-450-16, PED3-027-450-18, PED3-027-450-20, PED3-027-450-25, PED3-027-450-30, PED3-027-450-40, PED3-027-500-14, PED3-027-500-16, PED3-027-500-18, PED3-027-500-20, PED3-027-500-25, PED3-027-500-30, PED3-027-500-40, PED3-027-550-16, PED3-027-550-18, PED3-027-550-20, PED3-027-550-30, PED3-027-550-40, PED3-027-550-50, PED3-027-600-16, PED3-027-600-18, PED3-027-600-20, PED3-027-600-30, PED3-027-600-40, PED3-027-600-50
Reason for recall
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
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-1245-2025. 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.