Lysus Infusion System - Lysus Drug Delivery Catheter: The Lysus Infusion System employs high frequency (2-2.5 MHz), low
FDA device recall Z-0111-06 · posted 2005-11-01 · Terminated
Recall details
- Recalling firm
- Ekos Corp
- Reason for recall
- During two separate procedures, the user experienced difficulty placing the EKOS ultrasound core (USC) into the EKOS drug delivery catheter (DDC) when transiting tight bend radii; specifically the aortic bifurcation. In one case, the USC fractured within the DDC when the user attempted to withdraw the USC after resistance was encountered
- Action taken
- On 11/22/04 the firm issued letters to those customers that had product. The letters advised of the problem and provided amended use instructions.The firm continued to ship product and on 3/10/05 the firm visited consignees, replacing the catheters.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- 134 kits
- Distribution
- Kits were distributed to 6 hospitals in the US, 1 each located in AZ, OH, WA, FL, IL, and CA. The firm also distributed to a customer in Germany.
- Date initiated
- 2004-11-22
- Date posted
- 2005-11-01
- Date terminated
- 2005-11-09
- 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 (K042456) | Ekos Corp. | 2004-09-23 |