Embolization Device Recall and Correction: Medtronic Removes Unused 027 Compatible Pipeline Vantage Embolization Device with Shield Technology, Updates Use Instructions for 021 Compatible Pipeline Vantage Embolization Devices due to Increased Risk of Incomplete Wall Apposition and Braid Deformation
The FDA has identified this recall as the most serious type.
This recall involves:
- removing the Pipeline Vantage 027 device models from where they are used or sold
- updating instructions for using the Pipeline Vantage 021 device models
Affected Product
- Product Names:
- Removal of unused: Pipeline Vantage Embolization Device with Shield Technology, 027 Compatible (Pipeline Vantage 027 devices)
- Instructions for Use (IFU) update: Pipeline Vantage Embolization Device with Shield Technology, 021 Compatible (Pipeline Vantage 021 Devices)
- Catalog and Serial Numbers:
- Removal of unused: 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 and all Pipeline Vantage 027 product lots from B317266 through B817292
- Instructions For Use (IFU) update: 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. All Pipeline Vantage 021 product lots from B317266 through B817292
Unique Device Identifier (UDI)/Catalog Number:
| UDI | Device Model |
|---|---|
| 00847536030398 | PED3-021-250-10 |
| 00847536036215 | PED3-021-250-10 |
| 00847536034884 | PED3-021-250-10 |
| 00847536030404 | PED3-021-250-12 |
| 00847536034891 | PED3-021-250-12 |
| 00847536036222 | PED3-021-250-12 |
| 00847536030411 | PED3-021-250-14 |
| 00847536034907 | PED3-021-250-14 |
| 00847536036239 | PED3-021-250-14 |
| 00847536030428 | PED3-021-250-16 |
| 00847536034914 | PED3-021-250-16 |
| 00847536036246 | PED3-021-250-16 |
| 00847536036253 | PED3-021-250-18 |
| 00847536030442 | PED3-021-250-20 |
| 00847536034938 | PED3-021-250-20 |
| 00847536036260 | PED3-021-250-20 |
| 00847536030466 | PED3-021-275-12 |
| 00847536034952 | PED3-021-275-12 |
| 00847536036284 | PED3-021-275-12 |
| 00847536030473 | PED3-021-275-14 |
| 00847536034969 | PED3-021-275-14 |
| 00847536036291 | PED3-021-275-14 |
| 00847536030480 | PED3-021-275-16 |
| 00847536034976 | PED3-021-275-16 |
| 00847536036307 | PED3-021-275-16 |
| 00847536036314 | PED3-021-275-18 |
| 00847536030503 | PED3-021-275-20 |
| 00847536034990 | PED3-021-275-20 |
| 00847536036321 | PED3-021-275-20 |
| 00847536030527 | PED3-021-300-12 |
| 00847536035010 | PED3-021-300-12 |
| 00847536036345 | PED3-021-300-12 |
| 00847536030534 | PED3-021-300-14 |
| 00847536035027 | PED3-021-300-14 |
| 00847536036352 | PED3-021-300-14 |
| 00847536030541 | PED3-021-300-16 |
| 00847536035034 | PED3-021-300-16 |
| 00847536036369 | PED3-021-300-16 |
| 00847536036376 | PED3-021-300-18 |
| 00847536030565 | PED3-021-300-20 |
| 00847536035058 | PED3-021-300-20 |
| 00847536036383 | PED3-021-300-20 |
| 00847536030602 | PED3-021-325-12 |
| 00847536035096 | PED3-021-325-12 |
| 00847536036420 | PED3-021-325-12 |
| 00847536030619 | PED3-021-325-14 |
| 00847536035102 | PED3-021-325-14 |
| 00847536036437 | PED3-021-325-14 |
| 00847536030626 | PED3-021-325-16 |
| 00847536035119 | PED3-021-325-16 |
| 00847536036444 | PED3-021-325-16 |
| 00847536036451 | PED3-021-325-18 |
| 00847536030640 | PED3-021-325-20 |
| 00847536035133 | PED3-021-325-20 |
| 00847536036468 | PED3-021-325-20 |
| 00847536030688 | PED3-021-350-12 |
| 00847536035171 | PED3-021-350-12 |
| 00847536036505 | PED3-021-350-12 |
| 00847536030695 | PED3-021-350-14 |
| 00847536035188 | PED3-021-350-14 |
| 00847536036512 | PED3-021-350-14 |
| 00847536030701 | PED3-021-350-16 |
| 00847536035195 | PED3-021-350-16 |
| 00847536036529 | PED3-021-350-16 |
| 00847536036536 | PED3-021-350-18 |
| 00847536030725 | PED3-021-350-20 |
| 00847536035218 | PED3-021-350-20 |
| 00847536036543 | PED3-021-350-20 |
| 00847536030732 | PED3-021-350-25 |
| 00847536035225 | PED3-021-350-25 |
| 00847536036550 | PED3-021-350-25 |
| 00847536035263 | PED3-027-350-12 |
| 00847536030770 | PED3-027-350-12 |
| 00847536035287 | PED3-027-350-14 |
| 00847536030787 | PED3-027-350-14 |
| 00847536035294 | PED3-027-350-16 |
| 00847536030794 | PED3-027-350-16 |
| 00847536035317 | PED3-027-350-20 |
| 00847536030817 | PED3-027-350-20 |
| 00847536035324 | PED3-027-350-25 |
| 00847536030824 | PED3-027-350-25 |
| 00847536030862 | PED3-027-400-12 |
| 00847536035362 | PED3-027-400-12 |
| 00847536036680 | PED3-027-400-12 |
| 00847536030879 | PED3-027-400-14 |
| 00847536035379 | PED3-027-400-14 |
| 00847536036697 | PED3-027-400-14 |
| 00847536030886 | PED3-027-400-16 |
| 00847536035386 | PED3-027-400-16 |
| 00847536036703 | PED3-027-400-16 |
| 00847536036710 | PED3-027-400-18 |
| 00847536030909 | PED3-027-400-20 |
| 00847536035409 | PED3-027-400-20 |
| 00847536036727 | PED3-027-400-20 |
| 00847536030916 | PED3-027-400-25 |
| 00847536035416 | PED3-027-400-25 |
| 00847536036734 | PED3-027-400-25 |
| 00847536030923 | PED3-027-400-30 |
| 00847536035423 | PED3-027-400-30 |
| 00847536036741 | PED3-027-400-30 |
| 00847536030961 | PED3-027-450-12 |
| 00847536035461 | PED3-027-450-12 |
| 00847536036789 | PED3-027-450-12 |
| 00847536030978 | PED3-027-450-14 |
| 00847536035478 | PED3-027-450-14 |
| 00847536036796 | PED3-027-450-14 |
| 00847536030985 | PED3-027-450-16 |
| 00847536035485 | PED3-027-450-16 |
| 00847536036802 | PED3-027-450-16 |
| 00847536036819 | PED3-027-450-18 |
| 00847536031005 | PED3-027-450-20 |
| 00847536035508 | PED3-027-450-20 |
| 00847536036826 | PED3-027-450-20 |
| 00847536031012 | PED3-027-450-25 |
| 00847536035515 | PED3-027-450-25 |
| 00847536036833 | PED3-027-450-25 |
| 00847536031029 | PED3-027-450-30 |
| 00847536035522 | PED3-027-450-30 |
| 00847536036840 | PED3-027-450-30 |
| 00847536031043 | PED3-027-450-40 |
| 00847536035546 | PED3-027-450-40 |
| 00847536036864 | PED3-027-450-40 |
| 00847536031067 | PED3-027-500-14 |
| 00847536035577 | PED3-027-500-14 |
| 00847536036895 | PED3-027-500-14 |
| 00847536031074 | PED3-027-500-16 |
| 00847536035584 | PED3-027-500-16 |
| 00847536036901 | PED3-027-500-16 |
| 00847536036918 | PED3-027-500-18 |
| 00847536031098 | PED3-027-500-20 |
| 00847536035607 | PED3-027-500-20 |
| 00847536036925 | PED3-027-500-20 |
| 00847536031104 | PED3-027-500-25 |
| 00847536035614 | PED3-027-500-25 |
| 00847536036932 | PED3-027-500-25 |
| 00847536031111 | PED3-027-500-30 |
| 00847536035621 | PED3-027-500-30 |
| 00847536036949 | PED3-027-500-30 |
| 00847536031135 | PED3-027-500-40 |
| 00847536035645 | PED3-027-500-40 |
| 00847536036963 | PED3-027-500-40 |
| 00847536031166 | PED3-027-550-16 |
| 00847536035683 | PED3-027-550-16 |
| 00847536037007 | PED3-027-550-16 |
| 00847536037014 | PED3-027-550-18 |
| 00847536035706 | PED3-027-550-20 |
| 00847536031180 | PED3-027-550-20 |
| 00847536037021 | PED3-027-550-20 |
| 00847536031203 | PED3-027-550-30 |
| 00847536035720 | PED3-027-550-30 |
| 00847536037045 | PED3-027-550-30 |
| 00847536031227 | PED3-027-550-40 |
| 00847536035744 | PED3-027-550-40 |
| 00847536037069 | PED3-027-550-40 |
| 00847536031241 | PED3-027-550-50 |
| 00847536035768 | PED3-027-550-50 |
| 00847536037083 | PED3-027-550-50 |
| 00847536031289 | PED3-027-600-16 |
| 00847536035805 | PED3-027-600-16 |
| 00847536037120 | PED3-027-600-16 |
| 00847536037137 | PED3-027-600-18 |
| 00847536031302 | PED3-027-600-20 |
| 00847536035829 | PED3-027-600-20 |
| 00847536037144 | PED3-027-600-20 |
| 00847536031326 | PED3-027-600-30 |
| 00847536035843 | PED3-027-600-30 |
| 00847536037168 | PED3-027-600-30 |
| 00847536031340 | PED3-027-600-40 |
| 00847536035867 | PED3-027-600-40 |
| 00847536037182 | PED3-027-600-40 |
| 00847536031364 | PED3-027-600-50 |
| 00847536035881 | PED3-027-600-50 |
| 00847536037205 | PED3-027-600-50 |
What to Do
- Do not use and return all unused Pipeline Vantage 027 devices.
- Read updated instructions before using Pipeline Vantage 021 devices.
On January 30, 2025, Medtronic Neurovascular sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
For affected Pipeline Vantage 027 devices
- Do not use any affected Pipeline Vantage 027.
- Remove and quarantine all unused affected products.
- Return affected products to Medtronic with help from your Medtronic representative, who can also help identify suitable replacement products if needed.
For affected Pipeline Vantage 021
Download and review labeling updates M067713CDOC2 Rev. A (01/2025) (or M056989CDOC2 Rev. A) for the Pipeline Vantage 021 device. The updated Instructions for Use (IFU) was provided by Medtronic with the letter to healthcare providers and is also available on the Medtronic manuals website at: https://manuals.medtronic.com/manuals/. These instructions should be used when completing any future procedures with Pipeline Vantage 021.
The updates aim to help achieve optimal device size selection and stent braid deployment to reduce the risk of complications and patient harms by lowering the incidence of incomplete wall apposition and/or braid deformation. Revisions to the instructions include:
- Considerations to appropriately select device diameter and length accounting for complex anatomy.
- Techniques to deploy Pipeline Vantage compared to Pipeline Shield using a balance of device tension and compression, aiming to achieve adequate wall apposition and in complex vessel anatomies (e.g., tortuous vessels).
- Warnings about the consequences of incomplete wall apposition and suboptimal deployment as well as the increased risk of braid deformation in females, especially in females younger than 45 years of age.
For all affected devices
Complete the Customer Confirmation Form included with the letter and email it to neuro.quality@medtronic.com.
For patients who have already been treated with Pipeline Vantage 027 and 021 devices
The treating physician should determine the need for follow-up imaging or changes to medical management based on the patient’s overall health. This includes weighing the risks of dual antiplatelet therapy against potential risks for braid deformation.
Reason for Recall and Updates to Use Instructions
Medtronic Neurovascular is recalling 027 Compatible Pipeline Vantage Embolization Devices and updating use instructions for 021 Compatible Pipeline Vantage Embolization Devices due to reports of a higher incidence of the flexible, braided tube part of the device failing to properly attach or stay attached to the blood vessel wall (incomplete wall apposition and/or braid deformation) during and after procedures using these devices. Incomplete wall apposition and braid deformation, also sometimes called fish-mouthing, braid narrowing, or braid collapse, are known risks of these devices. The risks were higher in females, especially those younger than 45 years of age.
The use of affected product may cause serious adverse health consequences, including thrombosis, stroke, or death.
There have been thirteen reported injuries and four reports of death related to the 027 Compatible Pipeline Vantage Embolization Device. There have been four reported injuries and no reports of death related to the 021 Compatible Pipeline Vantage Embolization Device.
Device Use
Pipeline Vantage Embolization Devices with Shield Technology are used to treat bulges in the artery walls (aneurysms) of the brain. These devices are inserted into the blood vessels (endovascular) through a small catheter and delivered to the aneurysm location, where a small, braided tube is placed to block off blood flow to the bulging area.
Contact Information
Customers in the U.S. with questions about this recall should contact their local Medtronic representative or Medtronic Quality Assurance at rs.nvquality@medtronic.com or 1-800-633-8766.
Additional FDA Resources
- FDA’s Enforcement Report
- Medical Device Recall Database
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
- How do I recognize a UDI on a label?
- AccessGUDID database - Identify Your Medical Device
- Benefits of a UDI System
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.