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.
What this means for you
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
- 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.
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