Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of TerumoLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 7 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list MicroVention with 90 510(k) clearances and 38 device recalls. The most recent is a 510(k) clearance dated Sep 3, 2026: Mayumi™ Thrombectomy System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 3, 2026 | Mayumi™ Thrombectomy SystemK254035 · QEZ | 510(k) clearances |
| Jun 30, 2026 | ISAAC Neurovascular Navigation CatheterK261808 · QJP | 510(k) clearances |
| Jun 9, 2026 | BOBBY Balloon Guide CatheterK261549 · QJP | 510(k) clearances |
| Apr 30, 2026 | 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 insertClass II · Due to an increase rate of balloon pinhole defects. | Device recalls |
| Apr 6, 2026 | 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, 214518-CAClass II · Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorre | Device recalls |
| Sep 5, 2025 | Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED4528, FRED4026, FRED5526, FRED4508, FRED5514, FRED3536, FRED351Class II · Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which ma | Device recalls |
| Jun 13, 2025 | MV Flow Aspiration Pump (MVFLOWPMP01)K243638 · JCX | 510(k) clearances |
| May 29, 2025 | LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; 400 +/- 50 micrometers, REF: 8LP2S400Class II · Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to in | Device recalls |
| Dec 11, 2024 | MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.5 mm, TL 22 mm, WL 18 mm, Sterile R, CE0297. The intended purpClass II · Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out | Device recalls |
| Dec 2, 2024 | Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Coating, REF: MC172150SX-CN, Sterile R, Rx Only, Lot# 0000629846Class II · Sterility assurance; microcatheter inner packaging may contain incomplete seal. | Device recalls |
| Aug 5, 2024 | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retrieval Device is a mechanical thrombectomy device designed to restoClass II · Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which ex | Device recalls |
| May 16, 2024 | Wedge XL Delivery CatheterK232542 · QJP | 510(k) clearances |
| Dec 21, 2023 | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600Class II · Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the p | Device recalls |
| Sep 14, 2023 | SOFIA EX Intracranial Support CatheterK230775 · QJP | 510(k) clearances |
| Apr 27, 2023 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)K222694 · NTE | 510(k) clearances |
| Jan 10, 2023 | ISAAC Neurovascular Navigation CatheterK222115 · DQY | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
