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SHEATH INTRO TRAY KIT 7FR L5 MULT=5/50

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 680140 · UDI-DI 00886333601400

DYB Prescription

510(k) clearances

41,188

Adverse events (1,361 deaths)

389

Recalls

274

Facilities

Description

Kits contents: Precutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.02mm x ID 2.28mm x 10cm and Dilator; Guidewire 0.9 x 450mm; Introducers 1.7 x 70mm 1.4 x 70mm; Contamination Shield; Stopcock; Syringe; Scalpel.

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.