Recall Z-1367-2021 ยท MWS Stabilizer, Heart
Terumo Cardiovascular Systems Corporation
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm with links, a handle for providing cable tension, and a mechanism to mount the device to a sternal retractor.
| Date | Mar 2, 2021 |
| Status | Terminated |
| Reason | There is a potential for the stainless steel locking plates on the device's sternal retractor locking mechanism to fracture. |
| Root cause | Employee error |
| Action | A customer notification letter will be issued on 03/15/2021 by 2-day FedEx mailing to all (8 total) end users who have received affected product. Terumo CVS will provide a replacement device concurrent with the mailing. Customers will be advised to remove the affected product from use and to return product to Terumo CVS using the instructions provided in the customer letter. |
| Quantity | 12 |
| Distribution | US Nationwide distribution in the states of NH, WI, NJ, PA, NV, MD, TN, PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.