Reported Oct 22, 2025 · Ongoing

Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508,…

Microvention Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: MICROVENTION INC. · 35 Enterprise · Aliso Viejo, CA · 92656

Is this the product you have?

Flow Re-Direction Endoluminal DevicesFRED 27
REF
- FRED5019
- FRED5029
- FRED4528
- FRED4026
- FRED5526
- FRED4508
- FRED5514
- FRED3536
- FRED3511
- FRED5014
- FRED3516
- MV-F451827
- FRED X 27
REF
- XFRED4017-MVE
- XFRED4528-MVE
- MV-F501427X
- XFRED4518-MVE
- XFRED5526-MVE
- XFRED4539-MVE
- FREDX5522-PMA
- FREDX3522-PMA
- FREDX4525-PMA
- FREDX5015-PMA
- FREDX5532-PMA
- FREDX4013-PMA
- FREDX3513-PMA
- FREDX4515-PMA
- FREDX3517-PMA
- MV-F352427X

Lot codes and dates: 28 of 28 products
Products covered by this recall
# Barcodes Product as published
1 0081142502038800842429117163 FRED5019/00811425020388(0000235839), 00842429117163(0000544498)
2 0081142502039500842429117170 FRED5029/00811425020395(0000256343), 00842429117170(0000507209)
3 00811425020425 FRED4528/00811425020425(0000265666)
4 00811425021033 FRED4026/00811425021033(0000333125, 0000576973)
5 00842429117194 FRED5526/00842429117194(0000361117)
6 00842429117095 FRED4508/00842429117095(0000372088)
7 00842429117187 FRED5514/00842429117187(0000429786, 0000478385)
8 00842429117033 FRED3536/00842429117033(0000460268, 0000445555)
9 00842429117002 FRED3511/00842429117002(0000452923)
10 00842429117156 FRED5014/00842429117156(0000563591, 0000464401)
11 00842429117019 FRED3516/00842429117019(0000513146, 0000531733, 0000536217)
12 04987892121906 MV-F451827/04987892121906(0000565094)
13 00842429107508 XFRED4017-MVE/00842429107508(0000478838)
14 00842429107560 XFRED4528-MVE/00842429107560(0000518323, 0000663751)
15 04987892151231 MV-F501427X/04987892151231(0000579031)
16 00842429107553 XFRED4518-MVE/00842429107553(0000663074, 0000663750)
17 00842429107638 XFRED5526-MVE/00842429107638(0000704203)
18 00842429107577 XFRED4539-MVE/00842429107577(00007311620)
19 00842429114483 FREDX5522-PMA/00842429114483(0000265641, 0000469609, 0000731155)
20 00842429114315 FREDX3522-PMA/00842429114315(0000469598)
Page 1 of 2
Amount recalled: 467

Where it was sold

Nationwide
SD
CA
SC
TX
FL
CO
NE
NY
DE
IN
AR
PA

Why it was recalled

Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

This product could cause temporary or reversible health problems — stop using it.

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By hazard

Medical device recalls

Other recalls from Microvention Inc.

BOBBY Balloon Guide Catheter Aug 19, 2026
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking… May 20, 2026
LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers Aug 6, 2025
MicoVention Terumo, LVIS Intraluminal Support Device Feb 19, 2025
Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating Jan 29, 2025
ERIC Retrieval Device Sep 25, 2024

12 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Barcodes	Product as published
1	`0081142502038800842429117163`	FRED5019/00811425020388(0000235839), 00842429117163(0000544498)
2	`0081142502039500842429117170`	FRED5029/00811425020395(0000256343), 00842429117170(0000507209)
3	`00811425020425`	FRED4528/00811425020425(0000265666)
4	`00811425021033`	FRED4026/00811425021033(0000333125, 0000576973)
5	`00842429117194`	FRED5526/00842429117194(0000361117)
6	`00842429117095`	FRED4508/00842429117095(0000372088)
7	`00842429117187`	FRED5514/00842429117187(0000429786, 0000478385)
8	`00842429117033`	FRED3536/00842429117033(0000460268, 0000445555)
9	`00842429117002`	FRED3511/00842429117002(0000452923)
10	`00842429117156`	FRED5014/00842429117156(0000563591, 0000464401)
11	`00842429117019`	FRED3516/00842429117019(0000513146, 0000531733, 0000536217)
12	`04987892121906`	MV-F451827/04987892121906(0000565094)
13	`00842429107508`	XFRED4017-MVE/00842429107508(0000478838)
14	`00842429107560`	XFRED4528-MVE/00842429107560(0000518323, 0000663751)
15	`04987892151231`	MV-F501427X/04987892151231(0000579031)
16	`00842429107553`	XFRED4518-MVE/00842429107553(0000663074, 0000663750)
17	`00842429107638`	XFRED5526-MVE/00842429107638(0000704203)
18	`00842429107577`	XFRED4539-MVE/00842429107577(00007311620)
19	`00842429114483`	FREDX5522-PMA/00842429114483(0000265641, 0000469609, 0000731155)
20	`00842429114315`	FREDX3522-PMA/00842429114315(0000469598)