Arrow-Clark VectorFlow hemodialysis catheters recalled for sheath introducer failure risk
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.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2157-2026More Arrow recalls
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