Greatbatch Medical recalls Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The Mob…

Recall date

February 15, 2017

Source

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

Recall number

Z-2782-2017

FDA classification

Class II

Brand / firm

Greatbatch Medical

Sold / distributed

CA

Why it was recalled

One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.

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

What was recalled

Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The kit includes a flexible catheter dilator to facilitate bi-directional guiding sheath passage.