Reported Sep 28, 2016 · Terminated
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
EKOS Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: EKOS Corporation · 11911 N Creek Pkwy S · Bothell, WA · 98011-8809
Is this the product you have?
- EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
- Lot codes and dates
- Table 1Device Identification Information Catalog Number; Lot Number; Serial Number; Expiration Date 500-5518; 160711017; 160711017-005; 06-30-2019 500-5518; 160711017; 160711017-006; 06-30-2019. 500-5518; 160711017; 160711017-003; 06-30-2019. 500-5518; 160711017; 160711017-004; 06-30-2019. 500-5512; 160711042; 160711042-010; 06-30-2019. 500-5518; 160711017; 160711017-001; 06-30-2019. 500-5518; 160711017; 160711017-002; 06-30-2019. 500-5518; 160711017; 160711017-007; 06-30-2019. 500-5518; 160711017; 160711017-008; 06-30-2019. 500-5518; 160711017; 160711017-009; 06-30-2019. 3001627457 08/09/2016-002R CONFIDENTIAL 3 ¿ Name, address, and type of responsible firm on label; number and description of private labels
- ManufacturerEKOS Corporation 11911 North Creek Parkway South Bothell, WA 98011 ¿ Collect a complete copy of all labeling (include product inserts, information sheets.) Applicable labeling is included in Attachment 1. B
- CODEALL lot and/or serial numbers, batch numbers, catalog numbers, product numbers, packer or manufacturer numbers, etc., exactly as they appear on the product, container, or labeling. There are 10 total devices in distribution. Identification information for the
- implicated devices is found in Table 1Table 1: Device Identification Information Catalog Number Lot Number Serial Number Expiration Date¿ Give a breakdown of the code Catalog Number consists of 7 digits (XXX-YYYY), where; ¿ XXX represents a product family, ¿ YYYY represents a specific configuration, such as working length/treatment zone length
500-5518160711017160711017-00506-30-2019500-5518160711017160711017-00606-30-2019500-5518160711017160711017-00306-30-2019500-5518160711017160711017-00406-30-2019500-5512160711042160711042-01006-30-2019500-5518160711017160711017-00106-30-2019500-5518160711017160711017-00206-30-2019500-5518160711017160711017-00706-30-2019500-5518160711017160711017-00806-30-2019500-5518160711017160711017-00906-30-2019
- Amount recalled
- 10 units
Why it was recalled
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
This product could cause temporary or reversible health problems — stop using it.
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