Malleable Single Stage Venous Cannula with Carmeda Bioactive Surface, Model CB681XX Series

• • Terminated Z-1924-2008 FDA Unclassified (pre-2012) ·initiated 9 May 2008

  Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were manufactured with contaminated heparin. Medtronic's heparin supplier recently reported that it had provided some batches to Medtronic that were contaminated with oversulfated chondroitin sulfate (OSCS).

510(k) Number

K033264 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the CB681XX venous cannula designed for?

  The Medtronic CB681XX malleable single-stage venous cannula is specifically designed for venous drainage during cardiopulmonary bypass procedures. Its Carmeda bioactive surface helps enhance biocompatibility and minimize the risk of clotting, ensuring safer and more effective perfusion during cardiac surgeries. This makes it ideal for use in operating rooms or cardiac catheterization labs where extracorporeal circulation is required.

• Is the CB681XX cannula single-use or reusable?

  The CB681XX venous cannula is intended for single-use only. This design choice aligns with clinical best practices for maintaining sterility and reducing infection risks in sensitive procedures like cardiopulmonary bypass. Always follow manufacturer guidelines to ensure proper handling and disposal after a single use.

• How should the CB681XX cannula be stored to maintain sterility?

  The CB681XX cannula must be stored according to Medtronic’s guidelines to preserve its sterility and performance. It is packaged for sterile use, so it should remain in its original, unopened packaging until immediately before use. Exposure to moisture, contamination, or improper handling can compromise sterility, so always store it in a clean, dry environment away from direct sunlight or extreme temperatures.

• What distinguishes the Carmeda bioactive surface on this cannula?

  The Carmeda bioactive surface on the CB681XX cannula is engineered to improve biocompatibility by reducing the body’s adverse response to the foreign material. This coating helps lower the risk of thrombogenic events—such as clot formation—during prolonged use in cardiopulmonary bypass. The result is a safer perfusion experience for patients undergoing cardiac surgeries, as it minimizes complications associated with blood contact.

• Are there different sizes or models within the CB681XX series?

  The CB681XX series includes multiple models, each tailored to specific patient needs and procedural requirements. While the exact sizes or variations are not detailed in the provided data, the series is designed to accommodate different venous access scenarios during cardiopulmonary bypass. Always refer to the manufacturer’s documentation or consult with a clinical specialist to select the appropriate model for your patient’s anatomy and surgical plan.