Recall Z-2544-2016— LeMaitre Vascular, Inc.
Class II · Terminated
Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2016-08-03, terminated 2021-04-08. It names one FDA 510(k) clearance: K140042. 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. Reason: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable.
- Recalling firm
- LeMaitre Vascular, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-03
- Terminated
- 2021-04-08
- Firm location
- Burlington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Data sourced from openFDA. This site is unofficial and independent of the FDA.