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Catheter, Hemodialysis, Implanted

FDA product code MSD · Class 2 · Gastroenterology, Urology

0
Registered devices
11,493
Adverse events
270
Recalls
124
510(k) clearances

Devices with this code

Hemo-Cath® — Medical Components, Inc.Amecath dual lumen catheter — Ameco Medical IndustriesVACCESS LT LONG-TERM HEMODIALYSIS CATHETER PLUS — Bard Access Systems, Inc.Palindrome — Mozarc Medical US LLCDecathlon DF Long-Term Hemodialysis Catheter — Bard Access Systems, Inc.DuraFlow — ANGIODYNAMICS, INC.MEDCOMP TESIO CATHETERSMEDCOMP TESIO CATHETERS — Medical Components, Inc.TITAN HD — Medical Components, Inc.Amecath X split catheter — Ameco Medical IndustriesEQUISTREAM XK Alphacurve Long-Term Hemodialysis Catheter — Bard Access Systems, Inc.CentrosFLO® — Merit Medical Systems, Inc.Decathlon DF Long-Term Hemodialysis Catheter — Bard Access Systems, Inc.Palindrome — Mozarc Medical US LLCMEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETER — Medical Components, Inc.Hemo-Flow® — Medical Components, Inc.Split Cath® — Medical Components, Inc.ARROW — TELEFLEX INCORPORATEDEQUISTREAM XK Long-Term Hemodialysis Catheter with Preloaded Stylet — Bard Access Systems, Inc.DuraMax® — Merit Medical Systems, Inc.Split Cath® III — Medical Components, Inc.Amecath dual lumen catheter — Ameco Medical IndustriesAmecath Y split catheter — Ameco Medical IndustriesBioFlo — NAVILYST MEDICAL, INC.VACCESS LT LONG-TERM HEMODIALYSIS CATHETER — Bard Access Systems, Inc.

Recent recalls

DateFirmReason
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl
2026-04-10ARROW INTERNATIONAL, LLC16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not spl
2026-02-13Merit 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,
2026-02-13Merit 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,
2026-02-13Merit 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,
2026-02-13Merit 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,
2025-04-23Mozarc Medical US LLCPotential breach of sterile barrier packaging.
2025-04-23Mozarc Medical US LLCPotential breach of sterile barrier packaging.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.