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Open, Classified

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

FDA Recall Z-2157-2026 · Posted 2026-05-13

Recalling FirmARROW INTERNATIONAL, LLC
Recall StatusOpen, Classified
Product CodeMSD
Date Initiated2026-04-10
Product Quantity92,827

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.

Firm Action

On 4/10/2026, recall notices were mailed to customers who were informed of the following Arrow International LLC is recalling product due to the Merit Medical Systems, Inc. recall of the Merit 16F Dual-Valved Splitable Sheath Introducer component, which is included in impacted Arrow Hemodialysis Kits & Sets. Customers were asked to do the following: 1) Users should cease use and distribution of affected product and immediately quarantine the affected product. 2) Complete and return the Acknowledgement Form, see link: https://fca.myteleflex.com/en/recall/000605 3) This notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. In addition, distributors were asked to do the following: - Provide a copy of this field safety notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you as their distributor. Should you require further information or support concerning this issue, please contact Customer Service via email ([email protected]), phone (1-866-396-2111), or FAX (1-855-419-8507).

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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