PipelineTM Vantage Embolization Device with Shield TechnologyTM PED3-021-275-20Recalls & reported problems

Micro Therapeutics, Inc. · STENT PED3-021-275-20 V03 VANTAGE · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00847536036321), received between Nov 1, 2024 and Nov 1, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Device Damaged by Another Device” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Jan 30, 2025Class IOpen, Classified
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
Z-1246-2025 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Device problems

Device Damaged by Another Device1
Material Deformation1
Physical Resistance/Sticking1
Retraction Problem1

Patient problems

Perforation of Vessels1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryNov 1, 2024Retraction Problem; Device Damaged by Another Device; Material Deformation; Physical Resistance/Sticking; Retraction Problem; Device Damaged by Another Device; Material Deformation; Physical Resistance/Sticking
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DOCTOR THOUGHT THE ORIGINAL VANTAGE MAY HAVE MIGRATED BECAUSE THE DISTAL BRAID OF THE PIPELINE LANDED TOO CLOSE TO THE NECK OF THE ANEURYSM AND DIDN¿T HAVE ENOUGH PURCHASE TO STAY IN POSITION. THERE WAS NO DAMAGE TO THE PIPELINE OR PUSHER WIRE USED FOR THE ORIGINAL CASE DONE ON (B)(6) 2024.
Patient problems: Perforation of Vessels
MAUDE report 20585138 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

Z-1245-2025 · Jan 30, 2025 · Open, Classified
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, PE
Z-2402-2021 · Jul 13, 2021 · Open, Classified
Pipeline Flex Embolization Device
Z-2403-2021 · Jul 13, 2021 · Open, Classified
EV3 Pipeline Flex Embolization Device with Flex Shield Technology
Z-1527-2020 · Feb 14, 2020 · Terminated
ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
Z-0308-2017 · Oct 5, 2016 · Terminated
Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04
Z-0309-2017 · Oct 5, 2016 · Terminated
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled
Z-0307-2017 · Oct 5, 2016 · Terminated
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracrani
Z-0310-2017 · Oct 5, 2016 · Terminated
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
Z-0120-2016 · Sep 4, 2015 · Terminated
-Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based
Z-1453-2014 · Apr 1, 2014 · Terminated
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Z-2045-2013 · Jul 19, 2013 · Terminated
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-neck

Device details

UDI-DI	`00847536036321`
Brand	PipelineTM Vantage Embolization Device with Shield TechnologyTM
Model	PED3-021-275-20
Company	Micro Therapeutics, Inc.
Product code	OUT · Intracranial aneurysm flow diverter
Class	Class 3
FDA submission	P100018
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jan 8, 2024

Device type (GMDN): Bare-metal intracranial vascular stent

A non-bioabsorbable tubular device typically intended to be implanted into the base or parent artery of an intracranial aneurysm (e.g., wide-neck aneurysm situated at the base of a bifurcation) to facilitate the delivery of embolics to fill the aneurysm, facilitate clotting within the aneurysm by slowing blood flow into it, and/or to provide support for a neurovascular embolization coil placed inside the aneurysm. It is made of uncoated metal [e.g., nickel-titanium alloy (Nitinol)] and self-expands after it is delivered to the site of implantation and released (e.g., from a dedicated delivery instrument). Disposable devices associated with implantation may be included.

Other Intracranial aneurysm flow diverter devices

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PIPELINE PED-500-35
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PIPELINE PED-500-16
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1 recall2 deaths27 reports
PIPELINE PED-500-25
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1 recall1 death23 reports
PIPELINE PED-500-30
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1 recall21 reports
PIPELINE PED-450-25
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1 recall20 reports
PIPELINE PED-475-30
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1 recall1 death19 reports

All Intracranial aneurysm flow diverter devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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