Home › Device types › MGZ
Valvulotome
FDA product code MGZ · Class 2 · Cardiovascular
48
Registered devices
131
Adverse events
6
Recalls
27
510(k) clearances
Devices with this code
Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCEze-Sit Valvulotome — Lemaitre Vascular, Inc.Hydro LeMaitre Valvulotome — Lemaitre Vascular, Inc.Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCTru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCSymmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Antegrade and Retrograde LeMills Valvulotome — Lemaitre Vascular, Inc.HYDRO LeMaitre Valvulotome — Lemaitre Vascular, Inc.Antegrade and Retrograde LeMills Valvulotome — Lemaitre Vascular, Inc.Boomerang — Aveera Medical Inc.Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Tru-Incise Valvulotome with Interchangeable Heads — URESIL, LLCOver-the-Wire LeMaitre Valvulotome — Lemaitre Vascular, Inc.Wexler Surgical, Inc. — WEXLER SURGICAL, INC.Retrograde LeMills Valvulotome — Lemaitre Vascular, Inc.Boomerang — Aveera Medical Inc.HYDRO LeMaitre Valvulotome — Lemaitre Vascular, Inc.Symmetry Surgical — ASPEN SURGICAL PRODUCTS, INC.Expandable LeMaitre Valvulotome — Lemaitre Vascular, Inc.Expandable LeMaitre Valvulotome — Lemaitre Vascular, Inc.LimFlow Vector — Inari Medical, Inc.Expandable LeMaitre Valvulotome — Lemaitre Vascular, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-05 | LimFlow, Inc. | Incorrect expiration date |
| 2023-07-13 | LeMaitre Vascular, Inc. | Burrs (molding flash) on the cutter may tear the harvested vien |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2016-08-03 | LeMaitre Vascular, Inc. | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| 2014-09-08 | Instrumed International, Inc. | The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and theref |
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 keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.