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
Reported: August 24, 2016 Initiated: August 3, 2016 #Z-2544-2016
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
Details
- Recalling Firm
- LeMaitre Vascular, Inc.
- Units Affected
- 380 units
- Distribution
- 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.
- Location
- Burlington, MA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by LeMaitre Vascular, Inc.. Units affected: 380 units.
Why was this product recalled? ▼
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 24, 2016. Severity: Moderate. Recall number: Z-2544-2016.
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