Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0864-2016·Announced 2016-03-02

EKOS EkoSonic Endovascular System Recalled for Incorrect Working Length Labeling

EKOS Corporation is recalling 10 units of the EkoSonic Endovascular System because the device is labeled with a 135 cm working length, but the actual working length is 106 cm.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error regarding working length. No injuries, illnesses, or deaths are reported in the source text, fitting the criteria for a moderate severity score involving minor labeling errors or low-risk issues.

Plain-English summary

EKOS Corporation is recalling 10 units of the EkoSonic Endovascular System, Catalog Number 500-56112. The recall involves Lot Number 150910004, with an expiration date of August 15, 2018, and serial numbers 001 through 010. The affected units were distributed in Arizona, California, Massachusetts, Michigan, Ohio, and Virginia.

The recall was initiated because the EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC), is labeled with a 135 cm working length and programmed with a 135 cm family code. However, the actual working length of the MSD is 106 cm. This discrepancy between the labeled specifications and the physical device characteristics constitutes the basis for the recall.

The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Users should stop using the affected devices and contact EKOS Corporation for further instructions.

The recalled product

Product: EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic…
Manufacturer: EKOS Corporation
Category: Medical Device — Endovascular
Hazard: mis-labeling
Affected units: 10

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 (11)

Lot Number 150910004. Expiration date is August 15
2018. Serial numbers: 001
002
003
004
005
006
007
008
009
010

Distribution

Distributed in 6 states:

Same manufacturer · EKOS Corporation

See all →

Moderate
EKOS Corporation Recalls EKOS Carts Due to Missing Wheel Washers
FDA (Devices) · 2016-10-05
Moderate
EKOS Intelligent Drug Delivery Catheter Recalled for Potential Epoxy Defect
FDA (Devices) · 2016-09-28
Moderate
EKOS EkoSonic Control Unit Recalled Due to Cable Recognition Failure
FDA (Devices) · 2015-07-29
Moderate
EKOS EkoSonic Control Unit Recalled for Missing AC Filter
FDA (Devices) · 2013-11-13
High
EKOS MACH4 Endovascular Device Recalled for Catheter Marker Dislodgement
FDA (Devices) · 2012-07-25

Same hazard · mis labeling