MicroVention Inc.
16 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (16)
Registered facilities (2)
- MicroVention, Inc. FEI 3013556777 · CA
- MicroVention Costa Rica S.R.L. FEI 3010079067 · CR
Recalls & enforcement
20262 records
- Class IIOngoing2026-04-30Due to an increase rate of balloon pinhole defects.
- Class IIOngoing2026-04-06Stent-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 IIOngoing2025-09-05Flow 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 IIOngoing2025-05-29Drug 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 IIOngoing2024-12-11Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
- Class IIOngoing2024-12-02Sterility assurance; microcatheter inner packaging may contain incomplete seal.
- Class IIOngoing2024-08-05Due 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 IIOngoing2023-12-21Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
- Class IIOngoing2023-08-24Peripheral coil system detachable has a potential of unsealed pouch packaging.
- Class IIOngoing2023-06-07Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
20221 record
- Class IIOngoing2022-09-21Detachment 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 IITerminated2021-10-20Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
- Class IIITerminated2021-04-21Due to inadvertently shipping to U.S. customers with international labeling which has some differences with US-cleared labeling.
20192 records
- Class IITerminated2019-11-24The devices may be missing the implant coil.
- Class IITerminated2019-11-22The devices may be missing the implant coil.
20171 record
- Class IITerminated2017-08-07There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “MicroVention Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10033879-microvention-inc/
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