Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0637-2021 — 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 r

U.S. FDA — Device Enforcement · United States · 2020-11-03 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0637-2021
Date of alert: 2020-11-03
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Boston Scientific Corporation
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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