Stellar Guide Catheter
BALT USA LLC · Model STLR074132 · UDI-DI 00840303709640
Description
The Stellar Guide Catheter is a single-lumen, flexible, variable stiffness composite catheter. The distal tip of the catheter shaft includes a marker band while the proximal end of the catheter has a luer fitting to allow attachment of accessories and infusion of liquids through the system. The Stellar Guide Catheter distal shaft has an external hydrophilic coating which provides a lubricious surface during use. The Stellar Guide Catheter is visible under fluoroscopy. The Stellar Guide Catheter dimensions are included on the individual device label. The Stellar Guide Catheter is offered in various sizes to accommodate physician preferences and anatomical variations.
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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