FDA Device Intelligence
Home › ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. › SHEATH INTRO POP KIT 9FR L5 MULT=5/50

SHEATH INTRO POP KIT 9FR L5 MULT=5/50

ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Model 680156 · UDI-DI 00886333601561

DYB Prescription
10
510(k) clearances
41,696
Adverse events (1,374 deaths)
389
Recalls
274
Facilities

Description

Kits Contents : Percutaneous Sheath Introducer with Sideport Haemostasis Valve OD 3.70mm x ID 2.90mmx 10cm and Dilator, guidewire 0.9x450mm, Introducers 1.4x70mm, stopcock

Recalls

DateFirmReason
2026-06-15Terumo Medical CorporationProduct was packaged with the 0.025 guidewire instead of the 0.021 guidewire.
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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
2026-06-11Abiomed, 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.