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Terminated

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

FDA Recall Z-2545-2016 · Posted None

Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeMGZ
Date Initiated2016-08-03
Date Terminated2021-04-08
Product Quantity50 units

Reason for Recall

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

Firm 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.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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