EKOS Corporation EKOS 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
EKOS 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.
Brand
EKOS Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
EKOS Corporation is recalling EKOS EndoWave Infusion System consisting of a Drug Delivery Catheter and an Ultrasound Core. Labele due to Product mislabeled - 6 cm treatment zone catheter had been built using 50 cm treatment zone drilled tubing. Consequently, drug was delivered outside o. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
IL, IN, KY, MI, NY, NC, OH, WA
Page updated: Jan 10, 2026