Medtronic Pipeline Vantage Embolization Device with Shield Technology — Class I medical device recall Z-1246-2025

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-1246-2025`
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	7,820
UPC / GTIN / UDI-DI	`00847536030398`, `00847536030404`, `00847536030411`, `00847536030428`, `00847536030442`, `00847536030466`, `00847536030473`, `00847536030480`, `00847536030503`, `00847536030527`, `00847536030534`, `00847536030541`, `00847536030565`, `00847536030602`, `00847536030619`, `00847536030626`, `00847536030640`, `00847536030688`, `00847536030695`, `00847536030701`, `00847536030725`, `00847536030732`, `00847536034884`, `00847536034891`, `00847536034907` and 46 more
Lot numbers	`00847536034884/B387475`, `00847536036222/B326236`, `00847536036239/B317936`, `00847536036246/B328095`, `00847536036260/B321465`, `00847536036284/B323044`, `00847536036291/B343142`, `00847536036307/B323046`, `00847536036321/B391792`, `00847536036345/B338969`, `00847536036352/B327828`, `00847536036369/B321725`, `00847536036383/B322263`, `00847536036420/B324297`, `00847536036437/B324809`, `00847536036444/B324954`, `00847536036468/B325613`, `00847536036505/B368529`, `00847536036512/B349031`, `00847536036529/B317460`, `00847536036543/B319436`, `00847536036550/B364361`, `B327449`, `B332767`, `B333492`, `B333536`, `B334545`, `B335184`, `B335270`, `B335957`, `B336066`, `B336571`, `B337378`, `B338497`, `B339033`, `B340948`, `B345449`, `B346121`, `B346789`, `B347327` and 460 more
Model numbers	`M056989CDOC2`, `PED3-021-250-10`, `PED3-021-250-12`, `PED3-021-250-14`, `PED3-021-250-16`, `PED3-021-250-18`, `PED3-021-250-20`, `PED3-021-275-12`, `PED3-021-275-14`, `PED3-021-275-16`, `PED3-021-275-18`, `PED3-021-275-20`, `PED3-021-300-12`, `PED3-021-300-14`, `PED3-021-300-16`, `PED3-021-300-18`, `PED3-021-300-20`, `PED3-021-325-12`, `PED3-021-325-14`, `PED3-021-325-16`, `PED3-021-325-18`, `PED3-021-325-20`, `PED3-021-350-12`, `PED3-021-350-14`, `PED3-021-350-16` and 3 more

Product

Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PED3-021-275-12, PED3-021-275-16, PED3-021-325-12, PED3-021-325-14, PED3-021-325-16, PED3-021-325-20, PED3-021-250-12, PED3-021-300-14, PED3-021-250-16, PED3-021-300-12, PED3-021-275-14, PED3-021-350-14, PED3-021-350-25, PED3-021-350-12, PED3-021-250-10, PED3-021-275-20, PED3-021-350-18, PED3-021-325-18, PED3-021-275-18, PED3-021-250-18, PED3-021-300-18; and Instructions for Use, Part: M056989CDOC2

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-1246-2025. 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.