Recall Z-1491-2022 ยท QEY Mechanical Thrombolysis Catheter
Boston Scientific Corporation
EkoSonic Kit 135cm, 12cm TZ The EkoSonic Endovascular Device is packaged as a kit that includes both the USC and IC components. They are placed into the respective trays and sealed in a Tyvek pouch. The sealed pouches are placed inside the kit carton (box) and the product labels.
| Date | May 25, 2022 |
| Status | Open, Classified |
| Reason | Product may be mislabeled. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm notified affected consignees by telephone beginning May 25, 2022 to inform them of the potential of improperly packaged devices. On May 26, 2022, customer notifications, including a letter, instructions and reply form) were sent to all affected accounts via FedEx Overnight Delivery. Consignees are asked to return any affected and unused devices to BSC. The field removal letter will provide customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form (RVTF) indicating they have received the field remova |
| Quantity | 10 units |
| Distribution | US distribution only - CA, CT, GA, IA, IL, IN, NY, OH, TX, WY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213422 | EkoSonic Endovascular Device, EKOS+ Endovascular Device Boston Scientific Corporation, Dec 14, 2021 |