Terumo Cardiovascular Systems Corporation: Medical Device Recall in 2017 - (Recall #: Z-1201-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 20, 2014

Date Posted: February 22, 2017

Recall Number: Z-1201-2017

Event ID: 76344

Reason for Recall:

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.

Status: Terminated

Product Quantity: The total number of distributed devices stands at 260

Code Information:

Serial Number Range 70194 through 70504

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated