LeMaitre Vascular, Inc.: Medical Device Recall in 2013 - (Recall #: Z-1054-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips). Intended to be placed on the skin to assist during imaging procedures.

Product Classification:

Class II

Date Initiated: March 18, 2013

Date Posted: April 10, 2013

Recall Number: Z-1054-2013

Event ID: 64704

Reason for Recall:

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

Status: Terminated

Product Quantity: 6970

Code Information:

LSG1130, exp. 2017-04; LSG1132, exp. 2017-11

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Canada, EU, and Asia.

Voluntary or Mandated:

Voluntary: Firm initiated