Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2854-2016·Announced 2016-09-28

EKOS Intelligent Drug Delivery Catheter Recalled for Potential Epoxy Defect

EKOS Corporation is recalling 10 Intelligent Drug Delivery Catheters due to potential non-compliant manufacturing tests that may cause epoxy blisters.

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, but the source explicitly states it is not known if the defect adversely affects device operation, and no injuries or illnesses are reported, fitting the criteria for a moderate, precautionary recall.

Plain-English summary

EKOS Corporation is recalling ten units of the EKOS Intelligent Drug Delivery Catheter. The devices were distributed to three international consignees in Germany, New Zealand, and Taiwan. The recall was initiated because the devices potentially underwent a routine manufacturing test with non-compliant parameters.

This manufacturing issue may result in a small blister in the epoxy over the transducers in the treatment zone. At the time the recall was initiated, it was not known whether the non-compliant test parameters or the presence of the blisters adversely affect the operation of the device. The affected devices have catalog numbers 500-5518 and 500-5512, with expiration dates of 06-30-2019.

Healthcare providers and distributors should stop using the affected devices and contact EKOS Corporation for further instructions. The specific serial numbers for the ten affected units are listed in the official recall documentation.

The recalled product

Product: EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Manufacturer: EKOS Corporation
Category: Medical Device — Endovascular Catheter
Hazard: manufacturing-defect
device-malfunction
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 (20)

Table 1: Device Identification Information Catalog Number
Lot Number
Serial Number
Expiration Date 500-5518
160711017
160711017-005
06-30-2019 500-5518
160711017-006
06-30-2019. 500-5518
160711017-003
160711017-004
06-30-2019. 500-5512
160711042
160711042-010
160711017-001
160711017-002
160711017-007
160711017-008
160711017-009
06-30-2019. 3001627457 08/09/2016-002R CONFIDENTIAL 3 ¿ Name

Distribution

Distribution scope not specified by the agency.

Same manufacturer · EKOS Corporation

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