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Insyte Autoguard

BECTON, DICKINSON AND COMPANY · Model 382947 · UDI-DI 00382903829477

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

Description

BD Insyte™ Autoguard™ BC Pro Winged Shielded IV Catheter Blood Control Technology 18 GA x 1.88 IN

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.