Recall Z-0149-2023 ยท QEY Mechanical Thrombolysis Catheter
Boston Scientific Corporation
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
| Date | Oct 28, 2022 (initiated Oct 13, 2022) |
| Status | Open, Classified |
| Reason | Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued customer letters dated 10/13/2022 via FedEx overnight delivery on 10/13/2022 informing the customer certain serial numbers of the control units were shipped without an instruction for use (IFU) or contained an incorrect IFU. The customer was requested to complete and return the acknowledgment form to indicate receipt of the letter and the EKOS Control Unit 4.0 Instructions for Use (IFU). If the customer is a distributor, they are to follow the attached instructions (complete and return the acknowledgment form and place the provided IFU with their EKOS Control Unit |
| Quantity | 16 consoles |
| Distribution | Distribution was made to CA, IL, KY, OH, OK, RI, TX. There was no government/military distribution. Foreign distribution was made to Chile and Hong Kong. |
| FDA record | Open on fda.gov |