FDAClass IIJuly 12, 2017

Boston Scientific Imager II Angiographic Catheter recall

Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141…

Why was Boston Scientific Imager II Angiographic Catheter recalled?

A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

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: 00112758, Use by 2018-05-11

Product
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141…
Recalling firm
Boston Scientific Corporation
Quantity
39 boxes of 5 (195 units)
Distribution
CA, FL, KY, MO, NM, OK, OR, PA, and TX.
Recall date
July 12, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls