CLASS I ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report
Cannon II Plus Hemodialysis Catheter recalled by Arrow International
Arrow International is recalling Cannon II Plus Hemodialysis Catheter, distributed nationwide in the US. The recall was initiated on 10 Apr 2026 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2158-2026
- FDA event ID
- 98745
- Recalling firm
- Arrow International, Morrisville, NC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 10 Apr 2026
- FDA classified
- 13 May 2026
- Reported
- 20 May 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 10 Apr 2026 | Recall initiated by company | |
| 13 May 2026 | Classified by FDA | +33 days |
| 20 May 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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
Nationwide AlabamaArkansasCaliforniaColoradoDelawareIdahoIndianaMinnesotaPennsylvaniaTennessee
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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, 33F24H0256, 33F24J0040, 33F24L0183, 33F24M0222, 33F25A0426, 33F25C0022, 33F25C0593, 33F25E1082, 33F25G0024, 33F25H0297; CS-15362-VSP/30801902195525/33F23C0875, 33F23G0546, 33F23K0195, 33F24E0186, 33F24H0039, 33F24L0201, 33F24M0235, 33F25C0647, 33F25E0326, 33F25G0058, 33F25J0043; CS-15552-VSP/30801902195198/33F23G0552, 33F23H0987, 33F23L0961, 33F24C0070, 33F24E0820, 33F24H0257, 33F24L0068, 33F24M0227, 33F25C0654, 33F25E0432; CSD-15242-SP/20801902096610/33F24A0303, 33F25C0688; CSD-15282-SP/20801902096634/33F23K1087, 33F24A0297; CS-15242-SPM/10801902193527/33F23D0867, 33F23K0192, 33F24A0288, 33F24E0802, 33F24M0244, 33F25C0669, 33F25E0338, 33F25G0586; CS-15282-SPM/10801902193688/33F23C0872, 33F23D0864, 33F23G0539, 33F23L0949, 33F24A0278, 33F24C0075, 33F24E0808, 33F24H0254, 33F24J0036, 33F24L1166, 33F24M0233, 33F25A0413, 33F25C0666, 33F25H0824; CS-15322-SPM/30801902193538/33F23D0865, 33F23H1010, 33F23L0955, 33F24E0812, 33F25C0682, 33F25E0335; CS-15362-SPM/20801902193548/33F24G0062
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 98745This product is part of a recall event; the main page for the event is Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter recalled | Arrow International | Device Malfunction | Nationwide | |
| CLASS I | Arrow Edge Hemodialysis Catheterization Product recalled | Arrow International | Device Malfunction | Nationwide | |
| CLASS I | NextStep Antegrade Chronic Hemodialysis Catheter recalled | Arrow International | Device Malfunction | Nationwide |
More recalls from Arrow International
All 525| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Description/REF: Agba Picc G4 Stylet: 3L 6FR x 55CM recalled | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: Hemodialysis KIT: 2-Lumen 8 FR X 11 CM/AK recalled | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: PI CVC KIT recalled by Arrow International | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: PI Picc: 3: 6FR x 55CM w CHG/ Dlx-35563-Hpkc; Agba recalled | Arrow International | Sterility | Nationwide |
| Device | CLASS I | Description/REF: Pacing PSI KIT: 6 FR/AI-06210-KS, Pacing PSI KIT recalled | Arrow International | Sterility | Nationwide |
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