Facility

MicroVention, Inc.

16 recall(s) on record — most severe on record: Class II.

Key facts

16recalls · worst Class II

7inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3013556777
Establishment type	Repack or Relabel Medical Device; Develop Specifications But Do Not Manufacture At This Facility
Location	35 Enterprise Aliso Viejo, CA, US 92656
Registration status	Active · expires 2026
Parent company	MicroVention Inc. (owner-operator 10033879)
Brand names	Traxcess 14 Guidewire

Activity by year

Recalls (16)
Inspections (7)

Devices registered here (2)

Wire, Guide, Catheter
Product code DQX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1330
Guide, Wire, Catheter, Neurovasculature
Product code MOF (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1330

Recalls & enforcement

20262 records

Class IIOngoing2026-04-30
Due to an increase rate of balloon pinhole defects.
Class IIOngoing2026-04-06
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead …

20252 records

Class IIOngoing2025-09-05
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 syst…
Class IIOngoing2025-05-29
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than target vessel, increas…

20243 records

Class IIOngoing2024-12-11
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Class IIOngoing2024-12-02
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Class IIOngoing2024-08-05
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.

20233 records

Class IIOngoing2023-12-21
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Class IIOngoing2023-08-24
Peripheral coil system detachable has a potential of unsealed pouch packaging.
Class IIOngoing2023-06-07
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.

20221 record

Class IIOngoing2022-09-21
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller to properly detach the i…

20212 records

Class IITerminated2021-10-20
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Class IIITerminated2021-04-21
Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.

20192 records

Class IITerminated2019-11-24
The devices may be missing the implant coil.
Class IITerminated2019-11-22
The devices may be missing the implant coil.

20171 record

Class IITerminated2017-08-07
There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.

FDA inspections (7)

NAI2025-01-08
No Action Indicated · Bioresearch Monitoring
VAI2023-05-04
Voluntary Action Indicated · Compliance: Devices · citations posted
NAI2021-06-22
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2021-05-24
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
NAI2019-01-17
No Action Indicated · Bioresearch Monitoring
NAI2018-11-29
No Action Indicated · Compliance: Devices
NAI2016-08-25
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MicroVention, Inc. (FEI 3013556777) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013556777-microvention-inc/

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