Recall Z-0577-2007 ยท KRA Catheter, Continuous Flush
Ekos Corp
EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599
| Date | Mar 8, 2007 (initiated Feb 9, 2007) |
| Status | Terminated |
| Reason | Ekos Corporation received three reports that distal radiopaque marker bands on the EndoWave Drug Delivery Catheter became detached from the catheter during use and remained in the patient. |
| Root cause | Other |
| Action | On 2/9/07 the firm faxed and sent via certified return receipt an URGENT: Device Recall letter to their consignees. The letters requested to immediately examine stock and segregate all recalled products. In addition, the firm''s representatives will contact, via phone or visit, each of the consignees. Product is to be returned to the firm. |
| Quantity | 446 distributed |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060422 | LYSUS INFUSION SYSTEM Ekos Corp., Mar 9, 2006 |