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Catheter, Hemodialysis, Implanted
FDA product code MSD · Class 2 · Gastroenterology, Urology
2,304
Registered devices
11,428
Adverse events
270
Recalls
124
510(k) clearances
Devices with this code
VACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS — Bard Access Systems, Inc.BioFlo — NAVILYST MEDICAL, INC.Vaxcel — NAVILYST MEDICAL, INC.VACCESS LT LONG-TERM HEMODIALYSIS CATHETER — Bard Access Systems, Inc.HemoSplit Long-Term Hemodialysis Catheter — Bard Access Systems, Inc.BioFlo — NAVILYST MEDICAL, INC.Split Cath® — Medical Components, Inc.EvenMore — ANGIODYNAMICS, INC.HemoSplit XK Long-Term Hemodialysis Catheter — Bard Access Systems, Inc.ProGuide™ — Merit Medical Systems, Inc.Hemo-Flow® — Medical Components, Inc.HEMO-CATH® — Medical Components, Inc.ARROW — TELEFLEX INCORPORATEDSymetrex — Phase One Medical LLCDuraFlow 2 — Merit Medical Systems, Inc.HEMO-FLOW® — Medical Components, Inc.ARROW — TELEFLEX INCORPORATEDBIO-FLEX® TESIO¿ CATHETERS — Medical Components, Inc.HEMO-CATH® — Medical Components, Inc.Split Cath® III — Medical Components, Inc.CentrosFLO® — Merit Medical Systems, Inc.ARROW — TELEFLEX INCORPORATEDSplit Cath Spargo — Medical Components, Inc.Titan HD — Medical Components, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-10 | ARROW INTERNATIONAL, LLC | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl |
| 2026-04-10 | ARROW INTERNATIONAL, LLC | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl |
| 2026-04-10 | ARROW INTERNATIONAL, LLC | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl |
| 2026-04-10 | ARROW INTERNATIONAL, LLC | 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl |
| 2026-02-13 | Merit Medical Systems, Inc. | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, |
| 2026-02-13 | Merit Medical Systems, Inc. | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, |
| 2026-02-13 | Merit Medical Systems, Inc. | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, |
| 2026-02-13 | Merit Medical Systems, Inc. | 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, |
| 2025-04-23 | Mozarc Medical US LLC | Potential breach of sterile barrier packaging. |
| 2025-04-23 | Mozarc Medical US LLC | Potential breach of sterile barrier packaging. |
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