EKOS Control Unit 4.0 Recalled for Missing or Incorrect Instructions
Boston Scientific is recalling 16 EKOS Control Unit 4.0 consoles that were shipped without proper instructions for use or with incorrect instructions, creating risk of improper device operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device where correct instructions for use are essential for safe operation in clinical settings. While no illnesses or injuries have been reported, the missing or incorrect instructions create a risk of improper device operation by clinical staff. This meets the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling 16 EKOS Control Unit 4.0 consoles, a component of the EkoSonic Endovascular System. The consoles were shipped either without an instruction for use (IFU) or with an incorrect IFU.
Proper instructions for use are critical for safe operation of medical devices. Clinical staff rely on accurate IFU documentation to operate equipment correctly and ensure effective patient treatment. Consoles without correct instructions or with incorrect instructions may be operated improperly, creating risk of adverse outcomes.
The recalled consoles have been distributed to healthcare facilities in California, Illinois, Kentucky, Ohio, Oklahoma, Rhode Island, and Texas, as well as internationally to Chile and Hong Kong. Affected units are identified by specific serial numbers provided by the FDA. Healthcare facilities should verify that their EKOS Control Unit 4.0 consoles have proper instructions for use. Facilities with affected units should contact Boston Scientific directly for replacement instructions or device replacement.
The recalled product
- 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.
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
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