FuStarTM Steerable introducer
Lifetech Scientific (Shenzhen) Co., Ltd. · Model SVB7F-900 · UDI-DI 06938370117841
Description
The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or introducer sheath, which provides a pathway through whichdevices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low- profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of cathelters and devices. The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm(Large). Ineach option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination Also, the visible knob with scale of controller facillitates the physicians to estimate the deflecting angle of the sheath while intra-operation. The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French sie, 5F, 6F, 7F, 8F, 9F and 10F). The deflection angle of shealth is from 0 degree to 180 degree.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-30 | MICROVENTION INC. | Due to an increase rate of balloon pinhole defects. |
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited repo |
| 2025-09-25 | BALT USA, LLC | Due to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. |
| 2025-07-29 | Boston Scientific Corporation | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l |
| 2025-07-29 | Boston Scientific Corporation | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l |
| 2025-07-29 | Boston Scientific Corporation | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l |
| 2025-07-29 | Boston Scientific Corporation | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l |
| 2025-07-29 | Boston Scientific Corporation | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l |
| 2025-07-29 | Boston Scientific Corporation | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l |
| 2025-07-29 | Boston Scientific Corporation | Boston Scientific has identified a higher likelihood of air embolism events when procedures are performed without positive pressure-controlled ventilation. According to published l |
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