Recall Z-2448-2019— LeMaitre Vascular, Inc.

Name: FDA recall Z-2448-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-24

Class II · Terminated

Class II FDA medical device recall by LeMaitre Vascular, Inc., initiated 2019-07-24, terminated 2020-05-11. It names one FDA 510(k) clearance: K132022. 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: incorrect device size being listed on the impacted device packaging.

Recalling firm: LeMaitre Vascular, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-07-24
Terminated: 2020-05-11
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K132022 — LEMAITRE 8F OCCLUSION CATHETERLeMaitre Vascular, Inc.·cleared 2013-11-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

incorrect device size being listed on the impacted device packaging

Data sourced from openFDA. This site is unofficial and independent of the FDA.