FDA Device recall Z-1245-2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350…
- FDA Device
- Class I
- ongoing
- Published 2025-03-12
On 2025-03-12 the FDA classified a Class I recall of Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350… by Micro Therapeutics, citing 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 collaps….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1245-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-01-30 |
| Published | 2025-03-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Micro Therapeutics |
| Distribution | US |
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
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
Identifiers
| code_info | All unused devices. Product lots including and between B317266 and B817292. REF/UDI-DI/Lot: PED3-027-350-12/0084753603…All unused devices. Product lots including and between B317266 and B817292. REF/UDI-DI/Lot: PED3-027-350-12/00847536035263, 00847536030770/B409106, B637287, B700548; PED3-027-350-14/00847536035287, 00847536030787/B409234, B700550, B794880; PED3-027-350-16/00847536035294, 00847536030794/B409692, B697962, B700551, B795136, B795142, B809808; PED3-027-350-20/00847536035317, 00847536030817/B410645, B558444, B623124, B672921, B700552, B777630; PED3-027-350-25/00847536035324, 00847536030824/B410718, B672530, B700553, B771934, B771938; PED3-027-400-12/00847536030862, 00847536035362, 00847536036680/B321585, B336094, B349668,B371137, B409814, B414591, B437740, B482271, B594119, B597085, B598465, B612514, B616043, B616052, B647374, B649853, B655648, B658620, B658685, B666385, B666418, B671805, B720634, B720635, B744619, B744621, B756639, B765446, B765448, B780611, B786108; PED3-027-400-14/00847536030879, 00847536035379, 00847536036697/B318079, B335275, B339540, B350391, B364366, B372416, B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1245-2025%22
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