FDA-Device2026-05-20Class IPROCESSING DEFECT

Arrow International Cannon II Plus Hemodialysis Catheter recalled for sheath introducer malfunction risk

Nationwide distributionMedical devices

What this means

A faulty component supplied by a vendor — a 16F dual-valved splittable sheath introducer — was included in certain Arrow International hemodialysis catheter kits. The sheath may fail to split as designed during insertion, potentially causing procedural delays, pain, bleeding, bruising, or tissue damage.

Check the product reference numbers and lot codes on your catheter packaging against the FDA recall notice.
If you have an affected lot, contact your hospital or clinic to discuss safe alternatives before your next procedure.
Report any complications to your provider or to the FDA MedWatch program.

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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

34,568

Manufactured in

3015 Carrington Mill Blvd, Morrisville, NC, United States

Products

Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity Micro-Introducer, REF: CS-15242-SPM, CS-15282-SPM, CS-15322-SPM, CS-15362-SPM

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2158-2026

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