FDA Device recall Z-1201-2017
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
- FDA Device
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel by Terumo Cardiovascular Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1201-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-20 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | n/a |
Product
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
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.
Identifiers
| code_info | Serial Number Range 70194 through 70504 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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All Terumo Cardiovascular Systems recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1201-2017%22
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