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Recall Observatory FDA recall evidence

Device 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.

Z-2448-2019

July 24, 2019

Class II

Product summary

Firm
LeMaitre Vascular, Inc.
Event
Event 83535
Status
Terminated
Classification
Class II
Quantity
62 units
Official record key
device-enforcement:Z-2448-2019

Official wording

Reason: incorrect device size being listed on the impacted device packaging

Code information: Lot # OLC1051

Distribution pattern: GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    incorrect device size being listed on the impacted device packaging