EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Class I - DangerousWhat Should You Do?
- Check if you have this product: Table 1: Device 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. Manufacturer: EKOS 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. CODE: ALL 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 1: Table 1: Device 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 ¿ 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- EKOS Corporation
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Product Codes/Lot Numbers:
Table 1: Device 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. Manufacturer: EKOS 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. CODE: ALL 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 1: Table 1: Device 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 ¿ 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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2854-2016
Related Recalls
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The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm.
The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit.