Arrow International Recalls NextStep Hemodialysis Catheters
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ARROW INTERNATIONAL, LLC is recalling multiple NextStep Antegrade and Retrograde Hemodialysis Catheter models due to a sheath introducer that may not split as intended.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on June 2, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
ARROW INTERNATIONAL, LLC initiated a voluntary recall of NextStep Hemodialysis Catheters because the 16F dual-valved splittable sheath introducer included in impacted kits may not split as intended. This can result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, or vessel wall injury.
Which Products Are Affected
The recall covers 19,687 units of the following products distributed worldwide, including US nationwide:
- 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)
Specific lot numbers and UDI-DI codes are listed in FDA recall Z-2159-2026. The recall is classified as Class I.
What You Should Do
Consumers and healthcare providers should review the FDA recall notice for affected lot details and follow any instructions provided by the recalling firm.
Why This Matters
The Class I recall involves a device defect that may cause serious adverse health consequences during hemodialysis procedures.
Source
FDA Enforcement Report, recall number Z-2159-2026 (event ID 98745).
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,566 characters here).
Similar severity timing
Same severity (high) notices issued closest in time to June 2, 2026.
Frequently Asked Questions
Common questions about this FDA recall.