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FDA-Device2026-05-20Class IPROCESSING DEFECT

Arrow-Clark VectorFlow hemodialysis catheters recalled for sheath introducer failure risk

Arrow
Nationwide distribution

Arrow-Clark VectorFlow catheters recalled for introducer malfunction

Arrow International is recalling specific lots of Arrow-Clark VectorFlow hemodialysis catheters because they contain a faulty sheath introducer component from a supplier. The introducer may fail to split properly during insertion, which could cause difficulty withdrawing the device, prolonged procedure time, pain, and potential bleeding or tissue injury.

  • Check your facility's inventory against the affected reference numbers and lot codes listed in the FDA notice.
  • Do not use affected lots for new hemodialysis procedures.
  • Contact Arrow International or your supplier for device replacement and return instructions.
  • Report any injuries or adverse events associated with these devices to Arrow International and the FDA.
Hazard

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.

Sold states
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
Affected count
92,827
Manufactured in
3015 Carrington Mill Blvd, Morrisville, NC, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2157-2026

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