FDAClass IIJuly 12, 2017

Boston Scientific Extractor Pro recall

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300

Why was Boston Scientific Extractor Pro recalled?

Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

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 Number: 19343203 Exp.: 6/30/2018

Product
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
Recalling firm
Boston Scientific Corporation
Quantity
39 units
Distribution
MI, MO Foreign: Austria France Great Britain Italy Spain Sweden
Recall date
July 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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