Device 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
Z-2544-2016
Product summary
- Event
- Event 74880
- Status
- Terminated
- Classification
- Class II
- Quantity
- 380 units
- Official record key
device-enforcement:Z-2544-2016
Official wording
Reason: Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Code information: Lot Number Exp Date ELVH1078V¿ 2020-10 ELVH1079VA 2020-10
Distribution pattern: Worldwide Distribution - US Nationwide and in the countries of Australia, BELGIUM, BRAZIL, CANADA, Czech Republic, DENMARK, FINLAND, FRANCE, GERMANY, Italy, Japan, NETHERLANDS, Russia, Spain, SWEDEN, Switzerland, and UK.
Derived failure modes
-
Unknown
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable