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U.S. Department of Health and Human Services

Class 2 Device Recall EndoWave

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  Class 2 Device Recall EndoWave see related information
Date Initiated by Firm March 10, 2008
Date Posted September 02, 2008
Recall Status1 Terminated 3 on May 13, 2011
Recall Number Z-1752-2008
Recall Event ID 47245
510(K)Number K072507  
Product Classification Catheter, Continuous flush - Product Code KRA
Product 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
Code Information Model PT3B; Catalog Number 600-10301; Serial Number: PT3B-001, PT3B-002, PT3B-004, PT3B-006, PT3B-007, PT3B-008, PT3B-009, PT3B-010, PT3B-011, PT3B-012, PT3B-013, PT3B-014, PT3B-017, PT3B-018, PT3B-020, PT3B-021, PT3B-022, PT3B-024, PT3B-025, PT3B-027, PT3B-029, PT3B-030, PT3B-031, PT3B-032, PT3B-033, PT3B-034, PT3B-035, PT3B-037, PT3B-038, PT3B-040, PT3B-041, PT3B-042, PT3B-043, PT3B-044, PT3B-045, PT3B-046, PT3B-047, PT3B-049, PT3B-050, PT3B-051, PT3B-052, PT3B-057, PT3B-058, PT3B-059, PT3B-060, PT3B-062, PT3B-063, PT3B-064, PT3B-065, PT3B-066, PT3B-067, PT3B-068, PT3B-070, PT3B-071, PT3B-072, PT3B-073, PT3B-074, PT3B-075, PT3B-076, PT3B-078, PT3B-079, PT3B-080, PT3B-082, PT3B-084, PT3B-085, PT3B-087, PT3B-088, PT3B-089, PT3B-090, PT3B-091, PT3B-093, PT3B-094, PT3B-095, PT3B-096, PT3B-097, PT3B-098, PT3B-099, PT3B-100, PT3B-102, PT3B-103, PT3B-104, PT3B-108, PT3B-109, PT3B-110, PT3B-111, PT3B-112, PT3B-113, PT3B-114, PT3B-115, PT3B-118, PT3B-119, PT3B-121, PT3B-123, PT3B-124, PT3B-127, PT3B-128, PT3B-130, PT3B-131, PT3B-132, PT3B-133, PT3B-135, PT3B-137, PT3B-138, PT3B-139, PT3B-140, PT3B-141, PT3B-143, PT3B-145, PT3B-146, PT3B-147, PT3B-148, PT3B-150, PT3B-151, PT3B-152, PT3B-153, PT3B-154, PT3B-155, PT3B-156, PT3B-157, PT3B-158, PT3B-159, PT3B-163, PT3B-164, PT3B-165, PT3B-168, PT3B-169, PT3B-172, PT3B-173, PT3B-174, PT3B-175, PT3B-176, PT3B-177, PT3B-178, PT3B-180, PT3B-181, PT3B-183, PT3B-186, PT3B-188, PT3B-192, PT3B-193, PT3B-195, PT3B-196, PT3B-197, PT3B-199, PT3B-201, PT3B-202, PT3B-204, PT3B-205, PT3B-206, PT3B-207, PT3B-208, PT3B-210, PT3B-211, PT3B-212, PT3B-214, PT3B-215, PT3B-217, PT3B-218, PT3B-219, PT3B-221, PT3B-253, PT3B-254, PT3B-255, PT3B-256, PT3B-257, PT3B-258, PT3B-259, PT3B-260, PT3B-261, PT3B-262, PT3B-263, PT3B-264, PT3B-265, PT3B-266, PT3B-267, PT3B-268, PT3B-269, PT3B-270, PT3B-271, PT3B-273, PT3B-274, PT3B-275, PT3B-276, PT3B-280, PT3B-285, PT3B-286, PT3B-287, PT3B-288, PT3B-289, PT3B-291, PT3B-292, PT3B-294, PT3B-295, PT3B-297, PT3B-298, PT3B-308, PT3B-310, PT3B-311, PT3B-312, PT3B-313, PT3B-314, PT3B-315, PT3B-316, PT3B-319, PT3B-320, PT3B-321, PT3B-323, PT3B-326, PT3B-328, PT3B-329, PT3B-332, PT3B-333, PT3B-334, PT3B-335, PT3B-337, PT3B-338, PT3B-339, PT3B-344.
Recalling Firm/
Manufacturer		 EKOS Corporation
11911 N Creek Pkwy S
Bothell WA 98011-8809
For Additional Information Contact Jocelyn Kersten
425-415-3132
Manufacturer Reason
for Recall		 Potential for unit to burn patient.
FDA Determined
Cause 2		 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, the firm issued a new letter with the date of April 2008 informing customers of the issue. In addition the letter indicates that the corrective action, release of the new software is delayed to incorporate further changes, and that customers will be notified when the software is available for their unit. Customers are advised that the device is safe to use when operating according to the Instructions for Use. EKOS contact number 1-888-356-7435
Quantity in Commerce 218 units
Distribution Products were distributed nationwide to hospitals.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRA and Original Applicant = EKOS CORP.
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