Recall Z-2543-2016 ยท MGZ Valvulotome
LeMaitre Vascular, Inc.
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
| Date | Aug 3, 2016 |
| Status | Terminated |
| Reason | Wire which deploys the loop may be come detached at the handle causing the device to be inoperable |
| Root cause | Process control |
| Action | LeMaitre Vascular, Inc. sent an Urgent Medical Device Recall letter dated June 29, 2016 to customers via priority mail. The letter identified the affected product, problem and actions to be taken. Customers were requested to locate, quarantine and return the devices. Customers were instructed to complete and return the response form to LeMaitre Vascular, Inc. as a record of notification and reconciliation. Any unused product will be requested to be returned and replaced. For questions call 781-221-2266 ext. 183. |
| Quantity | 1992 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140042 | 1.5MM HYDRO EXPANDABLE LEMAITRE VALVULOTOME LeMaitre Vascular, Inc., Apr 10, 2014 |