Recall Z-0870-2021 ยท DQY Catheter, Percutaneous
Boston Scientific Corporation
ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide catheter removal after the Boston Scientific coronary venous lead is positioned.
| Date | Dec 15, 2020 |
| Status | Terminated |
| Reason | Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters distributed in the US that did not undergo the applicable sterile processing procedure. |
| Root cause | Process control |
| Action | The firm initiated the recall by hand delivered letter. The letter explained the issue and requested the following actions be taken: "1. Immediately segregate all affected product to ensure that it will not be used. 2. Your local Boston Scientific sales representative will retrieve affected product. 3. Complete the enclosed Reply Verification Tracking Form. 4. If affected product has been used, please inform the implanting physician for appropriate patient management." "If you have further questions, please contact your local Boston Scientific representative or United States Technical Service |
| Quantity | 5 units |
| Distribution | US Nationwide distribution including in the states of Tulsa, OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080154 | ACUITY UNIVERSAL CUTTER Cardiac Pacemakers, Inc., Mar 20, 2008 |