FDA Medical Device Recalls (openFDA)
Terumo Cardiovascular Systems Corporation: Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
- Recall number
- Z-1201-2017
- Recalling firm
- Terumo Cardiovascular Systems Corporation
- Product
- Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
- Status
- Terminated
- Initiated
- 2014-08-20
- Posted
- 2017-02-14
- Terminated
- 2017-02-15
- 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.
- Root cause
- Device Design
- Action
- Terumo Cardiovascular Systems has contact all affected parties (user facilities and consignees) via a Customer Notification Letter that advises of the recall activity.
- Quantity
- The total number of distributed devices stands at 260
- Distribution
- Terumo Cardiovascular has identified 16 domestic consignees and 30 international consignees .
- Lot, serial or model codes
- Serial Number Range 70194 through 70504
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MWS
- Firm FEI
- 3000204839
- Firm city
- Elkton
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28