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Shoocin

Lepu Medical Technology (Beijing) Co.,Ltd. · Model RS060721S-II · UDI-DI 06936733740897

DYB Prescription

510(k) clearances

40,654

Adverse events (1,345 deaths)

389

Recalls

273

Facilities

Description

The Puncture Needle incorporates a lumen, which provides a conduit for the insertion of the Guide Wire into the vascular system. The flexible stainless-steel guide wire is utilized as a guiding mechanism for the insertion of the Introducer 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. The Guide Wire is radio-detective under fluoroscopy. The Sheath Introducer contains Barium sulfate (BaSO4), making the device visible under fluoroscopy and provides a conduit for introducing other interventional devices, including guide wires and interventional catheters, into the vascular system. The main components of this assembly are a non-hydrophilic coated Sheath Introducer, hemostasis valve housing, and a side port tubing with a 3-way stopcock/valve. The 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. There is no radiocontrast agent on the dilator.

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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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.