Arrow International Recalls NextStep Hemodialysis Catheters

Source: FDA · United States

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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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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 ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
ARROW INTERNATIONAL, LLC is recalling multiple NextStep Antegrade and Retrograde Hemodialysis Catheter models due to a sheath introducer that may not split as intended.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.