FDAAugust 20, 2014device
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
terumo cardiovascular systemsterumoterumo cardiovascular
Recall history
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