Official recall notice

FDA DeviceClass INotable

Cannon II Recall (May 2026) – ARROW INTERNATIONAL

Product: 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

Recall date
2026-05-20
FDA class
Class I

Why it was recalled

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.

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Product description

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.

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