Arrow International, LLC medical device recall: Arrow Edge Hemodialysis Catheterization Product
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98745
- Recall initiated
- Apr 10, 2026
- Classified by FDA
- May 13, 2026
- Posted in Enforcement Report
- May 20, 2026
- Recalling firm
- ARROW INTERNATIONAL, LLC
- Firm location
- Morrisville, NC, United States
- Initiated by
- Voluntary: Firm initiated
- Products in this event
- 4
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
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.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 10, 2026. FDA classified it 33 days later, on May 13, 2026. This recall event covers 4 separate products, each with its own FDA recall number. Distribution reported by FDA: 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 ARROW INTERNATIONAL, LLC has 96 recalls in our records.
Recalled products (4)
Z-2156-2026 Class I Ongoing
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Codes / lots: REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545
Quantity: 285
Z-2157-2026 Class I Ongoing
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: CS-15192-VFM, CS-15232-VFM, CS-15272-VFM
Codes / lots: REF/UDI-DI/Lots: ACS-15192-VFI/ 10801902126709/33F23G0040, 33F25C0689; ACS-15232-VFI/10801902126723/33F23G0045, 33F25C0678; ACS-15272-VFI/ 10801902126747/33F24G0638; CS-15192-VFI/10801902127188, 10801902193572/33F23E0579, 33F23G0042, 33F23K0170, 33F23L0933, 33F24E0271, 33F24G0166, 33F24J0086, 33F24L0064, 33F24M0224, 33F25C0652, 33F25D0052, 33F25D0700, 33F25E1081, 33F25F0015, 33F25F0388, 33F25G0702, 33F25H0785; CS-15192-VFIE/10801902199659/33F23D0853, 33F23E0773, 33F23G0044, 33F23G0532, 33F23H0611, 33F23K0169,33F23K1105,33F23L0934, 33F24A0912, 33F24A0913, 33F24C0058, 33F24D1001, 33F24G0167,33F24G0187, 33F24J0030, 33F24J0032, 33F24J0339, 33F24J0381, 33F24K0659, 33F24L0058, 33F24L0511, 33F24M0155, 33F24M0215, 33F24M0265, 33F25A0143, 33F25A0407, 33F25B0259, 33F25C0037, 33F25D0285, 33F25D0738, 33F25F0060, 33F25G0635; CS-15232-VFI/10801902194463/33F23C0864, 33F23E0578, 33F23E0832, 33F23G0535,…
Quantity: 92,827
Z-2158-2026 Class I Ongoing
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
Codes / lots: REF/UDI-DI/Lots: CS-15242-VSP/30801902195273/33F23C0870, 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; CS-15282-VSP/30801902195518/33F23C0866, 33F23D0854, 33F23E0572, 33F23F0594, 33F23G0540, 33F23J0544, 33F23K0174, 33F23L0950, 33F24B0010, 33F24C0060, 33F24D0993, 33F24D1040, 33F24E0268, 33F24E0809, 33F24F0155, 33F24J0037, 33F24M0007, 33F24M0040, 33F24M0165, 33F24M0217, 33F25A0406, 33F25B0269, 33F25C0021, 33F25C0045, 33F25C0642, 33F25D0013, 33F25D0713, 33F25F0249, 33F25H0296, 33F25J0051; CS-15322-VSP/20801902195184/33F23C0869, 33F23D0862, 33F23F0723, 33F23H0985, 33F24A0272, 33F24C0066, 33F24E0813, 33F24G0170, 33F24G0185,…
Quantity: 34,568
Z-2159-2026 Class I Ongoing
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
Codes / lots: REF/UDI-DI/Lots: AC-15192-SFX/30801902197758/AC-15192-SFX; AC-15232-SFX/00801902095909/33F23H1018; CS-15192-SFX/30801902195297/33F23E0575, 33F23G0530, 33F23K0187, 33F23K1104, 33F23L0929, 33F24A0275, 33F24C0068, 33F24D1012, 33F25C0020, 33F25E1083, 33F25G0636, 33F25H0292, 33F25H0790, 33F25L0038; CS-15232-SFX/30801902195549/33F23E0576, 33F23G0534, 33F23L0936, 33F24A0279, 33F24C0067, 33F24D1006, 33F24E0684, 33F24H0258, 33F24J0033, 33F24J0085, 33F24J0342, 33F24L0056, 33F24M0231, 33F25A0405, 33F25C0036, 33F25C0664, 33F25D0739, 33F25E0433, 33F25G0716, 33F25H0248; CS-15272-SFX/10801902195217/33F23B0321, 33F23D0859, 33F23H0500, 33F23K0177, 33F23L0943, 33F24A0280, 33F24C0083, 33F24H0042, 33F24H0260, 33F24J0022, 33F24J0038, 33F24J0088, 33F24L0177, 33F25C0028, 33F25E1090, 33F25F0301, 33F25F0514; CS-15312-SFX/30801902197529/33F23G0541, 33F23H0984, 33F23L0951, 33F24A0283;…
Quantity: 19,687
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98745
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.