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Recall Observatory FDA recall evidence

Device product

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

Z-1201-2017

August 20, 2014

Class II

Product summary

Firm
Terumo Cardiovascular Systems Corporation
Event
Event 76344
Status
Terminated
Classification
Class II
Quantity
The total number of distributed devices stands at 260
Official record key
device-enforcement:Z-1201-2017

Official wording

Reason: 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.

Code information: Serial Number Range 70194 through 70504

Distribution pattern: Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.