FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-1752-2008
- Recalling firm
- EKOS Corporation
- 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
- Status
- Terminated
- Initiated
- 2008-03-10
- Posted
- 2008-09-02
- Terminated
- 2011-05-13
- 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, 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
- 218 units
- Distribution
- Products were distributed nationwide to hospitals.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K072507"]
- PMA numbers
- not on file
- Product code
- KRA
- Firm FEI
- 3001627457
- Firm city
- Bothell
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28