Cardiopulmonary Bypass

• 2 recalls, same reason

  • Ongoing Z-1796-2024 FDA Class II ·initiated 19 Mar 2024
  • Ongoing Z-1799-2024 FDA Class II ·initiated 19 Mar 2024

  Potential for unsealed sterile packing.

• • Ongoing Z-1316-2024 FDA Class II ·initiated 7 Feb 2024

  Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.

510(k) Number

K810820 ↗

FDA Product Code

DWF

Device Class

Class II

Regulation

21 CFR Part 870.4210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Infant Vent Catheter 12001 W/Side Vent Open recall

  Class II

  FDA 510(k) K834039 Active Cleared 3 Jan 1984

• Submission Coronary Cannula

  Class II

  FDA 510(k) K821149 Active Cleared 18 May 1982

• Percutaneous Guidewire Placement Syringe 50505

  Class II

  FDA 510(k) K855089 Active Cleared 18 Feb 1986

• Clearview Blower/Mister Open recall

  Class II

  FDA 510(k) K973485 Active Cleared 8 Dec 1997

• Dispossable Suction Tube, 6 French

  Class II

  FDA 510(k) K791846 Active Cleared 2 Oct 1979

• Aortic Root Cannula W/Integral Press

  Class II

  FDA 510(k) K831591 Active Cleared 30 Jun 1983

See all devices from Dlp, Inc. →

• What is the Cardiopulmonary Bypass System used for?

  The Cardiopulmonary Bypass System is designed to temporarily take over the functions of the heart and lungs during cardiac surgeries. It circulates and oxygenates blood outside the body, allowing surgeons to perform procedures such as coronary artery bypass grafting or heart valve replacements with minimal interruption of blood flow. This enables precise surgical access to the heart while maintaining critical blood circulation.

• Is the Cardiopulmonary Bypass System reusable or single-use?

  This system is supplied as a reusable device. After each use, it must undergo thorough cleaning, inspection, and maintenance to ensure safety and functionality for subsequent procedures. Proper sterilization and upkeep are essential to prevent contamination and maintain performance.

• What components does the Cardiopulmonary Bypass System include?

  The system includes cannulas, tubing, and connectors specifically designed for sterile surgical use. These components work together to facilitate blood circulation and oxygenation during cardiopulmonary bypass procedures. The design ensures compatibility with controlled surgical environments, such as operating rooms.

• How should the Cardiopulmonary Bypass System be stored?

  The system must be stored in a clean, dry environment away from direct sunlight or extreme temperatures. After cleaning and maintenance, components should be properly dried and stored in their original packaging or designated storage containers to prevent contamination and damage. Follow manufacturer guidelines for specific storage instructions.

• What regulatory clearance does the Cardiopulmonary Bypass System hold?

  The Cardiopulmonary Bypass System holds FDA 510(k) clearance under the product code DWF, classified as Class II with Special Controls. This clearance indicates that the device has been reviewed and deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness.