Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Affected Product
The FDA is aware that Merit Medical has issued a letter to affected customers recommending certain Dialysis catheters be removed from where they are used or sold. This introducer is a component of the following kits:
- Centros & CentrosFLO Hemodialysis Catheters
- ProGuide Chronic Dialysis Catheters
- 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile)
- DuraMax Chronic Hemodialysis Catheter
- BioFlo DuraMax Catheter
Reason for Removal
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 Merit finished devices. 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.
What to Do
Do not use Merit Medical 16F Dual-Valved Splittable Sheath Introducers.
On February 5, Merit Medical sent all affected customers a letter recommending the following actions:
- Immediately stop using the 16F Dual-Valved Splittable Sheath Introducer.
- Place the stickers provided by Merit Medical on the affected kits to ensure awareness of the recall.
- The sheath introducer should be destroyed at point of use.
Other products included with the sheath introducer may continue to be used.