Microvention recalls
12 official recalls and safety alerts involving Microvention since 2021-11, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Microvention or the relevant agency.
- 2026-08-19
USMICROVENTION INC. recalls BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US MV-BGA01095 For use in facilitating the insertion and…
Due to an increase rate of balloon pinhole defects.
FDA · DeviceMICROVENTION INC.Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice →- 2026-05-20
- US
MICROVENTION INC. recalls LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm,…
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,…
- 2025-10-22
- US
MICROVENTION INC. recalls Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536,…
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…
FDA · DeviceMICROVENTION INC.Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL,…Official notice → - 2025-08-06
- US
MICROVENTION INC. recalls LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400
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…
FDA · DeviceMICROVENTION INC.OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France,…Official notice → - 2025-02-19
- US
MICROVENTION INC. recalls MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended…
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
- 2025-01-29
- US
MICROVENTION INC. recalls Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
- 2024-09-25
- US
MICROVENTION INC. recalls ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restore…
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.
FDA · DeviceMICROVENTION INC.U.S. Nationwide distribution in the states of AR, CA, FL, IN, LA, MA, MN, MO,…Official notice → - 2024-02-07
- US
MICROVENTION INC. recalls TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
FDA · DeviceMICROVENTION INC.U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.Official notice → - 2023-11-08
- US
MICROVENTION INC. recalls AZUR CX 35 Peripheral Coil System Detachable 13mm x 24 CM, REF: 45-751324
Peripheral coil system detachable has a potential of unsealed pouch packaging.
FDA · DeviceMICROVENTION INC.US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.Official notice → - 2023-08-02
- US
MICROVENTION INC. recalls FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3511-PMA, FRED3516-CA, FRED3516-PMA, FRED3524, FRED3524-CA,…
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
FDA · DeviceMICROVENTION INC.Worldwide - US Nationwide distribution including in the states of AZ, NY, FL,…Official notice → - 2022-11-09
- US
MICROVENTION INC. recalls WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneurysm Embolization System.
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…
FDA · DeviceMICROVENTION INC.Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL,…Official notice → - 2021-11-10
- US
MICROVENTION INC. recalls Aspiration Syringe Kit, REF: MVSK60
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
FDA · DeviceMICROVENTION INC.US Nationwide distribution in the states of AL, NY, NV.Official notice →