Home › Device types › QEY

Mechanical Thrombolysis Catheter

FDA product code QEY · Class 2 · Cardiovascular

109

Registered devices

28

Adverse events

4

Recalls

71

510(k) clearances

Devices with this code

Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.BASHIR™ S-B .035 Endovascular Catheter — THROMBOLEX, INC.SpeedLyser — ANGIODYNAMICS, INC.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.Fountain® — Merit Medical Systems, Inc.

Recent recalls

Date	Firm	Reason
2023-11-06	Merit Medical Systems, Inc.	The sterility of microcatheter and infusion system devices cannot be guaranteed.
2022-10-13	Boston Scientific Corporation	Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
2022-05-25	Boston Scientific Corporation	Product may be mislabeled.
2022-05-25	Boston Scientific Corporation	Product may be mislabeled.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API key Read the docs

Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.