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U.S. Department of Health and Human Services

Class 2 Device Recall EndoWave Infusion System

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 Class 2 Device Recall EndoWave Infusion Systemsee related information
Date Initiated by FirmFebruary 20, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on May 13, 2011
Recall NumberZ-1892-2008
Recall Event ID 46923
510(K)NumberK072507 
Product Classification Continuous Flush Catheter - Product Code KRA
ProductEKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labeled as Sterile, Single Use Only. The device is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
Code Information 071126006-001, 071126006-002, 071126006-003, 071126006-005, 071204008-001, 071128015-001, 071128015-002, 071128015-003, 071128015-004, 071128015-005, Item number 500-52106, expiration date 2009-10
Recalling Firm/
Manufacturer		 EKOS Corporation
11911 N Creek Pkwy S
Bothell WA 98011-8809
For Additional Information ContactJocelyn Kersten
425-415-3132
Manufacturer Reason
for Recall		Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside of the treatment zone.
FDA Determined
Cause 2		Process control
ActionOn 02/20/08 firm notified customers by phone or email informing them of the issue and notifying them to segregate affected product and hold for return. Letters were sent via FedEx or email, or were hand delivered by firm representative to customers on 02/21/08 informing them of the issue and requesting return of affected product for replacement. Contact Jocelyn Kersten at 425-415-3132 if you have questions.
Quantity in Commerce10 units
DistributionProduct was distributed to hospitals in the following states: WA, NC, IL, OH, NY, MI, and KY with no foreign distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KRA
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