FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0149-2023
- Recalling firm
- Boston Scientific Corporation
- 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.
- Status
- Open, Classified
- Initiated
- 2022-10-13
- Posted
- 2022-10-28
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K162771","K183361","K200648"]
- PMA numbers
- not on file
- Product code
- QEY
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28