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U.S. Department of Health and Human Services

Class 2 Device Recall Hercules 360 Universal Stabilizing Arm

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 Class 2 Device Recall Hercules 360 Universal Stabilizing Armsee related information
Date Initiated by FirmAugust 20, 2014
Date PostedFebruary 14, 2017
Recall Status1 Terminated 3 on February 15, 2017
Recall NumberZ-1201-2017
Recall Event ID 76344
Product Classification stabilizer,heart - Product Code MWS
ProductHercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
Code Information Serial Number Range 70194 through 70504
FEI Number 3000204839
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
125 Blue Ball Rd
Elkton MD 21921-5315
For Additional Information ContactMary Swift
734-7416056
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionTerumo Cardiovascular Systems has contact all affected parties (user facilities and consignees) via a Customer Notification Letter that advises of the recall activity.
Quantity in CommerceThe total number of distributed devices stands at 260
DistributionTerumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
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