Microvention Inc.
Complete recall history across all FDA and CPSC categories — 13 total recalls
Microvention Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (13)
FDA medical device enforcement actions by Microvention Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 5, 2025 | Flow Re-Direction Endoluminal Devices: FRED 27, REF: FRED5019, FRED5029, FRED... | Flow diverter may have a manufacturing issue related to the tantalum length a... | Class II |
| May 29, 2025 | LIFEPEARL Drug Elutable Microspheres: 200 +/- 50 micrometers, REF: 8LP2S200; ... | Drug Elutable Microspheres have a smaller actual average diameter that is not... | Class II |
| Dec 11, 2024 | MicoVention Terumo, LVIS Intraluminal Support Device, REF: 213522-CAS, od, 3.... | Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop m... | Class II |
| Dec 2, 2024 | Microvention, Headway" 17 Advanced Straight Microcatheter with Hydrophilic Co... | Sterility assurance; microcatheter inner packaging may contain incomplete seal. | Class II |
| Aug 5, 2024 | ERIC Retrieval Device REF: ER173020 ER174030 ER176044 The ERIC Retriev... | Due to Retrieval Device product labels stating the incorrect expiration dates... | Class II |
| Dec 21, 2023 | TERUMO HydroPearl Compressible Microspheres for Embolisation REF 8HP2S600 | Due to, during the manufacturing process, the prescribed manufacturing and qu... | Class II |
| Aug 24, 2023 | 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. | Class II |
| Jun 7, 2023 | FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3... | Intracranial aneurysm flow diverter device may be manufactured with an incorr... | Class II |
| Sep 21, 2022 | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneury... | Detachment controller, of an aneurysm embolization system, has an out of spec... | Class II |
| Oct 20, 2021 | Aspiration Syringe Kit, REF: MVSK60 | Syringe Kits labeled for distribution OUS were inadvertently shipped to US cu... | Class II |
| Apr 21, 2021 | VIA Microcatheter VIA 27 REF VIA-27-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling w... | Class III |
| Apr 21, 2021 | VIA Microcatheter VIA 17 REF VIA-17-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling w... | Class III |
| Apr 21, 2021 | VIA Microcatheter VIA 21 REF VIA-21-154-01 - Product Usage: is a single lumen... | Due to inadvertently shipping to U.S. customers with international labeling w... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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