Home › Device types › DYB
Introducer, Catheter
FDA product code DYB · Class 2 · Cardiovascular
11,613
Registered devices
40,654
Adverse events
389
Recalls
706
510(k) clearances
Devices with this code
ARROW — TELEFLEX INCORPORATEDVersaCross Steerable Access Solution — Baylis Médicale Cie IncPrelude IDeal™ — Merit Medical Systems, Inc.SafeSheath® II — Oscor Inc.CORDIS — Cordis US Corp.NRG RF Transseptal Kit — Baylis Médicale Cie IncDemax — Beijing Demax Medical Technology Co., Ltd.Demax — Beijing Demax Medical Technology Co., Ltd.Demax — Beijing Demax Medical Technology Co., Ltd.MICRO-STICK®SET — Medical Components, Inc.Prelude SNAP™ — Merit MedicalVersaCross Steerable Access Solution — Baylis Médicale Cie IncENVI — NAVILYST MEDICAL, INC.ARROW — TELEFLEX INCORPORATED2F AND 3F VASCU-SHEATH TEARAWAY INTRODUCER2F AND 3F VASCU-SHEATH TEARAWAY INTROD — Medical Components, Inc.NRG RF Transseptal Kit — Baylis Médicale Cie IncWorley™ Adv. LVI — Merit MedicalNRG RF Transseptal Kit — Baylis Médicale Cie IncVersaCross Access Solution — Baylis Médicale Cie IncDestino Steerable Guiding Sheath — Oscor Inc.Hydrophilic Prelude SNAP™ — Merit Medical Systems, Inc.Adelante S — Oscor Inc.INTROCAN SAFETY® — B. BRAUN MEDICAL INC.Prelude EASE™ — Merit Medical Systems, Inc.
Recent 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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