Boston Scientific Corporation recalls Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vas…

Recall date

December 15, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2645-2017

FDA classification

Class II

Brand / firm

Boston Scientific Corporation

Sold / distributed

CA, FL, KY, MO, NM, OK, OR, PA, and TX.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)