FDA recall Z-2448-2019

Product

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.

Reason for recall

incorrect device size being listed on the impacted device packaging

Distribution

GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK

Key facts

Status

Terminated

Initiation date

2019-07-24

Report date

2019-09-11

Termination date

2020-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2448-2019