Recall Z-1201-2017 ยท MWS Stabilizer, Heart
Terumo Cardiovascular Systems Corporation
Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
| Date | Feb 14, 2017 (initiated Aug 20, 2014) |
| Status | Terminated |
| 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 . |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.