Recall Z-0149-2023
Boston Scientific Corporation · initiated October 13, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Codes / lots: Serial numbers CU4.0-01438, CU4.0-01524, CU4.0-01545, CU4.0-01560, CU4.0-01598, CU4.0-01610, CU4.0-01676, CU4.0-01804, CU4.0-01835, CU4.0-01840, CU4.0-01843, CU4.0-01897, CU4.0-01980, CU4.0-02022, CU4.0-02146, and CU4.0-02026, UPN 600-40500, GTIN 00858593006462.
Reason for recall
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
FDA-determined cause: Under Investigation by firm
Action taken
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 4.0 Console) and forward the notification to their customers. If the customer is a facility that has sent products to another hospital within their network, they are to follow the same attached instructions and ensure the notification is forwarded to the other hospitals if necessary.
Details
- Recall number
- Z-0149-2023
- Initiated
- October 13, 2022
- Posted by FDA
- October 28, 2022
- Product code
- QEY – Mechanical Thrombolysis Catheter
- 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.
- Recalling firm
- Boston Scientific Corporation, Maple Grove, MN