EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA Pa
FDA device recall Z-0577-2007 · posted 2007-03-08 · Terminated
Recall details
- Recalling firm
- Ekos Corp
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 446 distributed
- Distribution
- Nationwide.
- Date initiated
- 2007-02-09
- Date posted
- 2007-03-08
- Date terminated
- 2008-05-07
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LYSUS INFUSION SYSTEM (K060422) | Ekos Corp. | 2006-03-09 |