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FDA MedWatch
Early Alert: Arrow International Removes Dialysis Catheter Kits Containing Merit Medical Splittable Sheath Introducers
CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available. |
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KCER Release Date: April 27, 2026 To: KCER Distribution list- including ESRD Network EDs and QIDs Affected Product
The FDA is aware that Arrow International has issued a letter to affected customers recommending dialysis catheter kits containing Merit Medical 16F Dual-Valved Splittable Sheath Introducers be removed from where they are used or sold. Affected products:
Full list of affected product lots What to Do Do not use Merit Medical 16F Dual-Valved Splittable Sheath Introducers in the Arrow International kits and sets. In April, Arrow International sent all affected customers a letter recommending the following actions:
Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available. Reason for Removal Arrow International initiated an urgent Medical Device Recall notification for kits that contain hemodialysis catheters affected by Merit Medical’s Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer. Merit Medical is recalling the Merit 16F Dual-Valved Splittable Sheath Introducer due to a design defect where the sheath introducer may not split as intended. This sheath introducer is used in several impacted Arrow Hemodialysis Kits and Sets. Failure of the sheath introducer to split as intended may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access. As of February 23, Merit Medical has reported two serious injuries and no deaths associated with this issue. As of April 21, Arrow International has not reported any additional patient injuries or deaths. Device Use The 16F Dual-Valved Splittable Sheath Introducer is a component used in several Arrow Hemodialysis kits and sets and is packaged within the sterile barrier of the finished goods. The introducer is used for the delivery of the catheter into the vascular system. Contact Information Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Teleflex Customer Service at Recalls@teleflex.com or 1-866-396-2111. Additional FDA Resources Additional Company Resources Company-provided information is posted here by the FDA as a public service.
Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly.
How do I report a problem? Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
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