The Recall Desk

FDA (Devices) recall action 74880

LeMaitre Vascular, Inc. recalled 3 products on 2016-08-24

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2016-08-24
Critical
0
Units
2,422

Why these products were recalled

Wire which deploys the loop may be come detached at the handle causing the device to be inoperable

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–3 of 3

  • ModerateFDA (Devices)··2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices

    LeMaitre Vascular is recalling 50 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome, 40 cm. Sterile REF # 1010-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO Valvulotome Due to Wire Detachment

    LeMaitre Vascular is recalling 380 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome without LeMills, 98 cm. Sterile REF# 1009-00J Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2016-08-24

    LeMaitre Vascular Recalls 1.5 mm HYDRO LeMaitre Valvulotome Devices

    LeMaitre Vascular is recalling 1,992 units of the 1.5 mm HYDRO LeMaitre Valvulotome because the wire may detach at the handle, rendering the device inoperable.

    Product
    1.5 mm HYDRO LeMaitre Valvulotome, 98 cm, Sterile REF # 1009-00 Product Usage: The HYDRO LeMaitre Valvulotome is intended for the treatment of vascular disorders and more particularly for excising or disrupting venous valves
    Category
    Distribution
    0 states