Reported Dec 23, 2020 · Ongoing
EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 300 Boston Scientific Way · Marlborough, MA · 01752-1291
Is this the product you have?
- EKOS Control System (CU) 4.0. UPN 600-40500 The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device delivers the physician-specified fluids and ultrasound to the intravascular treatment site. The reusable Control Unit provides power to the device and provides the user interface for operator control. A reusable, non-sterile connector interface cable (CIC) connects the Control Unit to the Ultrasonic Core and Infusion Catheter.
- Lot codes and dates
- Serial numbers
106 of 106 codes
CU4.0-01062CU4.0-01063CU4.0-01066CU4.0-01068CU4.0-01069CU4.0-01070CU4.0-01072CU4.0-01073CU4.0-01074CU4.0-01076CU4.0-01078CU4.0-01079CU4.0-01081CU4.0-01083CU4.0-01084CU4.0-01086CU4.0-01088CU4.0-01089CU4.0-01090CU4.0-01091CU4.0-01093CU4.0-01094CU4.0-01095CU4.0-01096CU4.0-01097CU4.0-01100CU4.0-01101CU4.0-01102CU4.0-01103CU4.0-01104CU4.0-01106CU4.0-01107CU4.0-01108CU4.0-01110CU4.0-01113CU4.0-01114CU4.0-01115CU4.0-01116CU4.0-01117CU4.0-01119CU4.0-01121CU4.0-01123CU4.0-01124CU4.0-01126CU4.0-01127CU4.0-01128CU4.0-01129CU4.0-01130CU4.0-01131CU4.0-01132CU4.0-01133CU4.0-01134CU4.0-01135CU4.0-01138CU4.0-01141CU4.0-01142CU4.0-01143CU4.0-01144CU4.0-01146CU4.0-01147
- Serial numbers
- Amount recalled
- 90 (OUS)
Why it was recalled
This is a follow-up to the EKOS Field Safety Notice dated April 30, 2019. The Radio Frequency (RF) board has been redesigned to prevent occasional internal board failures at lower temperatures. All EKOS CU 4.0 consoles containing the old RF board design will be replaced with the newly designed CU 4.0 consoles.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Boston Scientific Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.