Arrow International Recalls VectorFlow Hemodialysis Catheters
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Arrow International, LLC is recalling 92,827 Arrow-Clark VectorFlow Hemodialysis Catheters worldwide 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 Worldwide. 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 certain Arrow-Clark VectorFlow 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 92,827 units distributed worldwide, including US nationwide and countries 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 products include:
Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter (REF: ACS-15192-VFI, ACS-15232-VFI, ACS-15272-VFI, CS-15192-VFI, CS-15192-VFIE, CS-15232-VFI, CS-15232-VFIE, CS-15272-VFI, CS-15272-VFIE, CS-15312-VFI, CS-15312-VFIE, CS-15422-VFI, CS-15422-VFIE, CS-15552-VFI, CS-15552-VFIE); Arrow-Clark VectorFlow Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer (REF: CS-15192-VFIM, CS-15232-VFIM, CS-15272-VFIM); Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter (REF: ACS-15192-VF, ACS-15232-VF, ACS-15272-VF, ACS-15552-VF, CS-15192-VF, CS-15192-VFE, CS-15232-VF, CS-15232-VFE, CS-15272-VF, CS-15272-VFE, CS-15312-VF, CS-15312-VFE, CS-15422-VF, CS-15422-VFE, CS-15552-VF, CS-15552-VFE); Arrow-Clark VectorFlow Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer (REF: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM).
Specific lots and UDI-DI are detailed in FDA recall Z-2157-2026. Recall initiation date: April 10, 2026. Classification: Class I.
What You Should Do
Consumers and healthcare providers should stop using the affected products and contact Arrow International, LLC for return or refund instructions.
Why This Matters
The recall involves a Class I device distributed worldwide, where failure of the sheath introducer poses risks of bleeding, tissue injury, and prolonged procedures.
Source
FDA Recall Z-2157-2026 - Arrow International, LLC, Morrisville, NC.
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 (2,246 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.