Critical Alert
ARROW INTERNATIONAL Recalls NextStep Antegrade Chronic Hemodialysis Catheter
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2159-2026Medical Device
ARROW INTERNATIONAL Recalls NextStep Antegrade Chronic Hemodialysis Catheter
ARROW INTERNATIONAL, LLC · Class I — Most Serious
Product Description
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
Reason for Recall
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.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
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
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class I recall — the most serious classification reserved for situations where there is a reasonable probability that use of, or exposure to, the product will cause serious adverse health consequences or death. ARROW INTERNATIONAL, LLC initiated this recall of medical device on April 10, 2026 affecting 19,687. 16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. The product was distributed internationally, including the United States. Consumers who have this product should stop using it immediately and contact the recalling firm.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects and Arrow International recalls.