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Stellar Guide Catheter

BALT USA LLC · Model STLR081110 · UDI-DI 00840303709657

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510(k) clearances

1,766

Adverse events (49 deaths)

Recalls

Facilities

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
2025-01-16	Scientia Vascular, Inc.	Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.
2024-08-30	Stryker Neurovascular	Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), different configuration
2024-04-23	Stryker Neurovascular	Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so t
2024-03-08	ROUTE 92 MEDICAL INC	Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
2024-03-08	ROUTE 92 MEDICAL INC	Their is the potential for distal tip separation at the proximal marker band of the delivery catheters.
2024-02-02	Medos International Sarl	Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injur
2023-12-06	Stryker, Inc.	The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.