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RAIN Sheath Transradial

Cordis US Corp. · Model 506616S · UDI-DI 10705032079006

DYB Prescription
10
510(k) clearances
41,188
Adverse events (1,361 deaths)
389
Recalls
275
Facilities

Description

6F16cm SW Radial

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

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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.