Z-0149-2023Class II

EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the...

Name: Z-0149-2023 EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the...
Creator: Boston Scientific Corporation
Published: 2022-10-13
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-10-13 / Open, Classified / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System on 2022-10-13. FDA classified it as Class II and gives the reason as "Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0149-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-10-13
Posted: 2022-10-28
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.
Product code: QEY Mechanical Thrombolysis Catheter
Reason for recall: Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0149-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0149-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-11-09	2022-10-28

Product code QEY

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)