Device Recall EKOS EndoWave(TM) Infusion System Drug Delivery Catheter

All Models with Serial Number greater than and equal to 0610XXXX-XXX

Cardiovascular Devices

2

No

Nationwide.

EKOS EndoWave Infusion System and EKOS Lysus Infusion Systems - drug delivery catheters. EKOS Corporation Bothell, WA || Packaging: *EndoWave(TM) Ultrasound Accelerated Thrombolysis (USAT) EKOS EndoWave Infusion System Drug Delivery Catheter with Ultrasound Core. and ''Lysus Infusion System''. || EndoWave Infusion Systems 06, 2.7W, part #4599-001, catalog #500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #500-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part 4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog #500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, catalog #500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130, Systems 40, 3.5W, part #5199-006, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150; || Lysus Infusion Systems 06, 2.7W, part #4599-001, catalog 500-52106; Systems 12, 2.7W, part #4599-002, catalog 500-52112; Systems 18, 2.7W, part #4599-003, catalog #50-52118; Systems 24, 2.7W, part #4599-004, catalog #500-52124; Systems 30, 2.7W, part #4599-005, catalog #500-52130; Systems 40, 2.7W, part #4599-006, catalog #500-52140; Systems 50, 2.7W, part #4599-007, catalog #500-52150; Systems 06, 3.5W, part #5199-001, catalog 500-54106; Systems 12, 3.5W, part #5199-002, catalog #500-54112; Systems 18, 3.5W, part #5199-003, 500-54118; Systems 24, 3.5W, part #5199-004, catalog #500-54124; Systems 30, 3.5W, part #5199-005, catalog #500-54130; Systems 40, 3.5W, part #5199-005, catalog #500-54140; Systems 50, 3.5W, part #5199-007, catalog #500-54150