LeMaitre Vascular, Inc.: Medical Device Recall in 2019 - (Recall #: Z-2448-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.

Product Classification:

Class II

Date Initiated: July 24, 2019

Date Posted: September 11, 2019

Recall Number: Z-2448-2019

Event ID: 83535

Reason for Recall:

incorrect device size being listed on the impacted device packaging

Status: Terminated

Product Quantity: 62 units

Code Information:

Lot # OLC1051

Distribution Pattern:

GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK

Voluntary or Mandated:

Voluntary: Firm initiated