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FDA recall, , High risk

Arrow Hemodialysis Catheters

Arrow Hemodialysis Catheters may not split as intended, causing withdrawal resistance, pain, bleeding, and tissue injury.

Summary by Recall Canary from the FDA notice

What happened

Arrow International, LLC of Morrisville, North Carolina, began a recall on April 10, 2026, of several hemodialysis catheter products, including the Arrow Edge Hemodialysis Catheterization Product, NextStep Antegrade Chronic Hemodialysis Catheter, Cannon II Plus Hemodialysis Catheter, and Arrow-Clark VectorFlow catheters.

The recall was added to the FDA's Enforcement Report on May 13, 2026, and classified by the FDA the same day.

The reason stated by the agency is that the 16F dual-valved splittable sheath introducer, subject to a supplier recall, was included in impacted kits and sets and may not split as intended, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, and vessel wall injury.

Distribution was nationwide and worldwide, including the US and many other countries.

More device defect recalls

2 photos

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

Compare the details below with your product and check the FDA notice to confirm whether it is affected.

A UDI-DI is the device identifier printed with the barcode on the device label.

  1. Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I

    UDI-DI
    • 30801902195280
    • 30801902195532
    • 30801902197451
    Lot code
    • CS-15242-I
    • 33F23G0536

  2. Product details

    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

    UDI-DI
    • 30801902197758
    • 00801902095909
    • 30801902195297
    • 30801902195549
    • 10801902195217
    • 30801902197529
    • 30801902195327
    • 30801902195563
    • 10801902127157
    • 10801902127232
    • 00801902095879
    • 00801902095916
    • 00801902095954
    • 30801902195303
    • 30801902195556
    • 10801902195224
    • 30801902195310
    • 10801902127225
    • 10801902127300
    • 10801902127409
    • 10801902127508
    Lot code
    • AC-15192-SFX

  3. Product details

    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

    UDI-DI
    • 30801902195273
    • 30801902195518
    • 20801902195184
    • 30801902195525
    • 30801902195198
    • 20801902096610
    • 20801902096634
    • 10801902193527
    • 10801902193688
    • 30801902193538
    • 20801902193548
    Lot code
    • CS-15242-VSP
    • 33F23C0870
    • 33F23D0857
    • 33F23F0719
    • 33F23K0182
    • 33F24A0265
    • 33F24C0062
    • 33F24D1000
    • 33F24D1039
    • 33F24E0803
    • 33F24H0038
    • 33F24H0261
    • 33F24K0505
    • 33F24M0039
    • 33F24M0218
    • 33F25A0141
    • 33F25C0657
    • 33F25D0125
    • 33F25E0305
    • 33F25E0429
    • 33F25E0430
    • 33F25E1131
    • 33F25F0042
    • 33F25G0070
    • 33F25H0295
    • 33F25H0366
    • 33F25H0674
    • 33F25J1015

  4. Product details

    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;

    UDI-DI
    • 10801902126709
    • 10801902126723
    • 10801902126747
    • 10801902127188
    • 10801902193572
    • 10801902199659
    • 10801902194463
    • 10801902195149
    • 10801902193640
    • 10801902127362
    • 10801902195255
    • 10801902197778
    • 10801902195491
    • 10801902193664
    • 10801902197440
    • 10801902193671
    • 10801902195163
    • 10801902193589
    • 10801902193619
    • 10801902197761
    • 10801902126693
    • 10801902126716
    • 10801902126730
    • 10801902126792
    • 20801902193593
    • 10801902195460
    • 10801902193626
    • 10801902195132
    • 10801902193657
    • 10801902195248
    • 10801902127447
    • 10801902195484
    • 10801902128666
    • 10801902197341
    • 10801902128703
    • 10801902195156
    • 10801902193602
    • 10801902193633
    • 10801902127393
    Lot code
    • ACS-15192-VFI
    • 33F23G0040
    • 33F25C0689

  5. Arrow-Clark VectorFlow Retrograde Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM

    UDI-DI
    • 10801902126709
    • 10801902126723
    • 10801902126747
    • 10801902127188
    • 10801902193572
    • 10801902199659
    • 10801902194463
    • 10801902195149
    • 10801902193640
    • 10801902127362
    • 10801902195255
    • 10801902197778
    • 10801902195491
    • 10801902193664
    • 10801902197440
    • 10801902193671
    • 10801902195163
    • 10801902193589
    • 10801902193619
    • 10801902197761
    • 10801902126693
    • 10801902126716
    • 10801902126730
    • 10801902126792
    • 20801902193593
    • 10801902195460
    • 10801902193626
    • 10801902195132
    • 10801902193657
    • 10801902195248
    • 10801902127447
    • 10801902195484
    • 10801902128666
    • 10801902197341
    • 10801902128703
    • 10801902195156
    • 10801902193602
    • 10801902193633
    • 10801902127393
    Lot code
    • ACS-15192-VFI
    • 33F23G0040
    • 33F25C0689

  6. Arrow-Clark VectorFlow Antegrade Hemodialysis Catheter with Arrow Simplicity Micro-Introducer: REF: CS-15192-Vfim, CS-15232-Vfim, CS-15272-Vfim;

    UDI-DI
    • 10801902126709
    • 10801902126723
    • 10801902126747
    • 10801902127188
    • 10801902193572
    • 10801902199659
    • 10801902194463
    • 10801902195149
    • 10801902193640
    • 10801902127362
    • 10801902195255
    • 10801902197778
    • 10801902195491
    • 10801902193664
    • 10801902197440
    • 10801902193671
    • 10801902195163
    • 10801902193589
    • 10801902193619
    • 10801902197761
    • 10801902126693
    • 10801902126716
    • 10801902126730
    • 10801902126792
    • 20801902193593
    • 10801902195460
    • 10801902193626
    • 10801902195132
    • 10801902193657
    • 10801902195248
    • 10801902127447
    • 10801902195484
    • 10801902128666
    • 10801902197341
    • 10801902128703
    • 10801902195156
    • 10801902193602
    • 10801902193633
    • 10801902127393
    Lot code
    • ACS-15192-VFI
    • 33F23G0040
    • 33F25C0689

  7. Product details

    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;

    UDI-DI
    • 10801902126709
    • 10801902126723
    • 10801902126747
    • 10801902127188
    • 10801902193572
    • 10801902199659
    • 10801902194463
    • 10801902195149
    • 10801902193640
    • 10801902127362
    • 10801902195255
    • 10801902197778
    • 10801902195491
    • 10801902193664
    • 10801902197440
    • 10801902193671
    • 10801902195163
    • 10801902193589
    • 10801902193619
    • 10801902197761
    • 10801902126693
    • 10801902126716
    • 10801902126730
    • 10801902126792
    • 20801902193593
    • 10801902195460
    • 10801902193626
    • 10801902195132
    • 10801902193657
    • 10801902195248
    • 10801902127447
    • 10801902195484
    • 10801902128666
    • 10801902197341
    • 10801902128703
    • 10801902195156
    • 10801902193602
    • 10801902193633
    • 10801902127393
    Lot code
    • ACS-15192-VFI
    • 33F23G0040
    • 33F25C0689

Recall details

Company began the recall
Sold in

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

Company
ARROW INTERNATIONAL, LLCMorrisville, North Carolina
Hazard
Device defect
Risk

High risk

There is a reasonable chance that using it could cause serious health problems or death.

FDA Class I recall · How risk is rated

Event ID
98745
Recall numbers
Z-2156-2026 to Z-2159-2026

All recalls from ARROW INTERNATIONAL, LLC

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Other device defect recalls

See all: Other device defect recalls

Summary by Recall Canary, written with AI · summary updated Oct 23, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)