LeMaitre Vascular, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1529-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage: intended to be used to perfuse contrast medias into the vessels for angiographic procedures, Catalog #: 4100-00.

Product Classification:

Class II

Date Initiated: April 6, 2021

Date Posted: May 12, 2021

Recall Number: Z-1529-2021

Event ID: 87689

Reason for Recall:

The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field.

Status: Terminated

Product Quantity: 616 units

Code Information:

Lot: LCI1091, LCI1092, LCI1093, LCI1094, LCI1095, LCI1096, LCI1097, LCI1098, LCI1099

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IL, IN, KY, MA, MO, NY, OH, TN, TX and the countries of Bahamas, Belgium, France, Germany, Hong Kong, Spain.

Voluntary or Mandated:

Voluntary: Firm initiated