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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow Edge catheter

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 Class 1 Device Recall Arrow Edge cathetersee related information
Date Initiated by FirmApril 10, 2026
Date PostedMay 13, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2156-2026
Recall Event ID 98745
510(K)NumberK111117 
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
ProductArrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Code Information REF/UDI-DI/Lot: CS-15242-I/ 30801902195280/33F23G0536; CS-15282-I/30801902195532/33F23C0877, 33F24A0281, 33F24H0041; CS-15322-I/30801902197451/33F23G0545
FEI Number 3013162291
Recalling Firm/
Manufacturer		 ARROW INTERNATIONAL, LLC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
For Additional Information ContactCustomer Service
866-396-2111
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 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 (Recalls@teleflex.com), phone (1-866-396-2111), or FAX (1-855-419-8507).
Quantity in Commerce285
DistributionWorldwide 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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MSD
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