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 as significant new information becomes available.
Affected Products
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.
- Arrow Edge Hemodialysis Catheterization Product
- Arrow-Clark VectorFlow Antegrade Chronic Hemodialysis Catheter
- Arrow-Clark VectorFlow Retrograde Chronic Hemodialysis Catheter
- Cannon II Plus Chronic Hemodialysis Catheter
- NextStep Antegrade Chronic Hemodialysis Catheter
- NextStep Retrograde Chronic Hemodialysis Catheter
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.
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:
- Immediately stop use and distribution of the affected kits and sets.
- Return affected kits and sets to Arrow International.
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.