GoBack Crossing Catheter
UPSTREAM PERIPHERAL TECHNOLOGIES LTD · Model GB 603-US 014P 80L · UDI-DI 07290017837239
Description
The Upstream™ GoBack (GB) Crossing Catheter is designed to address the needs of vascular interventionalists (Radiologists, Angiologists) and vascular surgeons when attempting to place a guidewire in the peripheral vasculature during endovascular procedures. The Upstream™ GB Crossing Catheter is intended to be used in conjunction with a steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires. The Upstream GoBack Crossing Catheter have outer diameter of 4FRr (1.4mm) or 2.9Fr (0.96mm), accommodate 0.018” or 0.014” guidewires accordingly, and both diameters have effective length of 80cm or 120 cm.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-11-14 | Bard Peripheral Vascular Inc | Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart require |
| 2020-10-16 | Ra Medical Systems, Inc. | Due to footswitch not meeting required specification for protection from ingress of solids or liquids. If spilling of liquids near or on the footswitch, it may fail in the 'on' po |
| 2020-07-24 | Ra Medical Systems, Inc. | Due to the taller wheel mounting on the laser, the laser may fall over potentially causing user or patient injury. |
| 2020-01-23 | Ra Medical Systems, Inc. | A software issue was identified which could result in user or patient injury, or may adversely impact laser performance. It is possible that an unintended release of laser light (r |
| 2019-09-19 | Ra Medical Systems, Inc. | The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently les |
| 2018-02-15 | Ra Medical Systems Inc | Lasers/Catheters did not calibrate during set-up prior to use. |
| 2015-07-22 | Volcano Corporation | Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Cathe |
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