Brilliant
Lepu Medical Technology (Beijing) Co.,Ltd. · Model RSC040721 · UDI-DI 06936733738306
Description
The puncture needle or an intravascular catheter incorporates a lumen, which provides a conduit for the insertion of the guide wire into the vascular system. The various types of guide wires, model dependent, are utilized as a guiding mechanism for the insertion of the introduction sheath into the vascular system. The guide wire contains a wire collimator, which assists in funneling the wire through the lumen of the puncture needle or the intravascular catheter and contains marking that are visible under fluoroscopy, which can determine the length of the guide wire within the vascular system. The sheath introducer provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vasculature. The main components of the sheath introducer assembly are a hydrophilic coated sheath introducer, hemostasis valve housing, and a side port with tubing connected to a 3-way stopcock/valve. The hydrophilic coated dilator is used to provide support and stability to the sheath introducer during deployment into the vascular system. The proximal end of the dilator includes a luer port and has a tapered, atraumatic distal tip. Both the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-15 | Terumo Medical Corporation | Product was packaged with the 0.025 guidewire instead of the 0.021 guidewire. |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
| 2026-06-11 | Abiomed, Inc. | A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visua |
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