Recall Z-0149-2023— Boston Scientific Corporation
Class II · Ongoing
Class II FDA medical device recall by Boston Scientific Corporation, initiated 2022-10-13. It names 3 FDA 510(k) clearances: K200648, K183361, K162771. 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.. Reason: Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU..
- Recalling firm
- Boston Scientific Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-10-13
- Firm location
- Maple Grove, MN, United States
510(k) clearances named in this recall
3 on FDA's record- K200648 — EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
- K183361 — EkoSonic Endovascular Device with Control Unit 4.0
- K162771 — EkoSonic Endovascular System with Control Unit 4.0
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a component of the EkoSonic Endovascular System.
Reason for recall
Consoles were shipped without an instruction for use (IFU) or with the incorrect IFU.
Data sourced from openFDA. This site is unofficial and independent of the FDA.