FDA-Device2026-05-20Class IPROCESSING DEFECT

Arrow International NextStep hemodialysis catheters recalled for introducer sheath splitting failure risk

OTHERNationwide distributionMedical devices

What this means

A supplier defect in the 16F dual-valved splittable sheath introducer used in certain Arrow NextStep hemodialysis catheter kits may prevent the sheath from splitting as designed. This can cause difficulty during catheter placement, leading to prolonged procedures and potential complications including bleeding, tissue injury, or vessel wall damage.

If you have one of the affected catheter kits, contact your healthcare provider or hospital before using it.
Check the product reference number (REF) and lot number on your catheter packaging against the recall list.
Do not use the affected catheters; return them to your supplier or facility for proper handling.

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The agency's original wording

Hazard

16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

Intended for

Adults

Illnesses reported

None reported

Sold states

Worldwide distribution: US nationwide and countries of: AE, AL, AR, AT, AU, BE, BG, BS, BR, BW, CA, CH, CL, CN, CO, CZ, DE, EC, EE, ES, FR, GB, GR, GT, HU, ID, IE, IN, IT, JP, KW, KZ, LB, LT, LU, MN, MZ, NA, NL, NO, NP, NZ, PA, PE, PF, PH, PL, PT, QA, RO, RS, RU, SA, SG, SL, SK, SZ, TH, TN, TR, TT, UA, VN, ZA, ZM, and ZW

Affected count

19,687

Manufactured in

3015 Carrington Mill Blvd, Morrisville, NC, United States

Products

NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-SFXM, CS-15232-SFXM; NextStep Retrograde Hemodialysis Catheter, REF: AC-15192-X, AC-15232-X, AC-15272-X, CS-15192-X, CS-15232-X, CS-15272-X, CS-15312-X; NextStep Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15192-XM, CS-15232-XM, CS-15272-XM, CS-15312-XM

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2159-2026

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