FDAClass IISeptember 11, 2019

The LeMaitre Aortic Occlusion Catheter is a single recall

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…

Why was The LeMaitre Aortic Occlusion Catheter is a single recalled?

incorrect device size being listed on the impacted device packaging

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # OLC1051

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…
Recalling firm
LeMaitre Vascular, Inc.
Quantity
62 units
Distribution
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Recall date
September 11, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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