Terumo Cardiovascular Systems Corporation recalls Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel

Recall date

August 20, 2014

Source

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

Recall number

Z-1201-2017

FDA classification

Class II

Brand / firm

Terumo Cardiovascular Systems Corporation

Sold / distributed

Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .

Why it was recalled

Terumo Cardiovascular Systems (Terumo CVS) is recalling certain lots of Hercules TM 360 Universal Stabilizing Arms because the two pins that hold the sleeve attached to the distal end of the device may come loose, causing the pins and sleeve to separate from the device. While the arm can still function without the pins and sleeve in place, there is potential for the loose components to fall into the surgical site.

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

What was recalled

Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel