Recall Z-1752-2008 ยท KRA Catheter, Continuous Flush
EKOS Corporation
PT-3B Control Unit - component of the EndoWave Infusion Catheter System. EndoWave Infusion System consists of three main components, a single use EndoWave Infusion Catheter System which is comprised of a Drug Delivery Catheter (CD) and removable Ultrasound Core (USC) and a reusable EKOS PT-3B Control System. Box is labeled EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core
| Date | Sep 2, 2008 (initiated Mar 10, 2008) |
| Status | Terminated |
| Reason | Potential for unit to burn patient. |
| Root cause | Software design |
| Action | In March 2008, the firm planned to visit each consignee to install the new software version 01.05.02 and hand deliver letters, dated 02/20/2008, notifying consignees of the reason for the action. The old software version is 01.04.02. The software was upgraded because the Ultrasound Core heats very quickly and if removed from the DDC while operating it may result in burns to the patient or user. The software will turn off the Ultrasound Core automatically if removed from the DDC during operation, and will prompt to restart therapy if ultrasound is turned off during treatment. On 04/17/2008, |
| Quantity | 218 units |
| Distribution | Products were distributed nationwide to hospitals. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072507 | ENDOWAVE INFUSION SYSTEM Ekos Corp., Oct 4, 2007 |