Dialysis Catheter Recall: Merit Medical Removes 16F Dual-Valved Splittable Sheath Introducer
Merit Medical is recalling the 16F Dual-Valved Splittable Sheath Introducer due to reports that the device may not split as intended during use.
This recall affects Merit Medical Systems, healthcare facilities performing dialysis catheter insertions, and clinical personnel utilizing large-bore splittable sheath introducers.
A failure of the sheath to split correctly presents significant clinical risks, including potential hemorrhage, air or thrombus embolization, and permanent loss of the vessel for future dialysis access. From a regulatory perspective, this suggests a critical mechanical performance failure that necessitates immediate field action and potential investigation into the manufacturing or design validation processes for these components.
QA and clinical teams should immediately inventory and quarantine any remaining 16F Dual-Valved Splittable Sheath Introducers. Regulatory departments must ensure all required recall notifications are documented and filed in accordance with post-market surveillance requirements. Clinical risk assessments should be conducted for patients who underwent procedures involving this device where complications were noted.
The Merit 16F Dual-Valved Splittable Sheath Introducer may not split as intended. This may cause bleeding, embolization, or loss of vessel for future access.
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