FDA recall record · openFDA

MICROVENTION INC.

9 FDA recalls on record (2023–2026) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorre 1

Sterility assurance; microcatheter inner packaging may contain incomplete seal. 1

Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform 1

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out 1

Peripheral coil system detachable has a potential of unsealed pouch packaging. 1

Recalls

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 m Class II 2026-04-06 LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400 Class II 2025-05-29 Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED551 Class II 2025-09-05 Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx On Class II 2024-12-02 MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297 Class II 2024-12-11 ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy devi Class II 2024-08-05 FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED352 Class II 2023-06-07 AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324 Class II 2023-08-24 TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 Class II 2023-12-21

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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