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.
FDA Recall Z-1892-2008 · Posted 2008-09-16
Recalling FirmEKOS Corporation
Recall StatusTerminated
Product CodeKRA
Date Initiated2008-02-20
Date Terminated2011-05-13
Product Quantity10 units
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Product was distributed to hospitals in the following states: WA, NC, IL, OH, NY, MI, and KY with no foreign distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.