FDAClass IIJanuary 22, 2014

Boston Scientific Extractor Pro XL Retrieval Balloon recall

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110

Why was Boston Scientific Extractor Pro XL Retrieval Balloon recalled?

Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

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: 16231174

Product
Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Recalling firm
Boston Scientific Corporation
Quantity
38 units
Distribution
Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls