FDA Early Alert Covers Arrow Dialysis Catheter Kits With Recalled Merit Sheath Introducers

The US Food and Drug Administration has issued an Early Alert about Arrow International's removal of dialysis catheter kits that contain a recalled Merit Medical sheath introducer, according to the agency's alert dated April 24, read in that version via the Internet Archive. The American Hospital Association reported the alert to its members on April 27.

CDRH issues Early Alerts "to notify the public of a potentially high-risk device issue," the notice says. The FDA said it is reviewing information about the issue and will update the page as significant new information becomes available.

Six kit families affected

The alert lists six Arrow chronic hemodialysis catheter products: the Arrow Edge Hemodialysis Catheterization Product, the Arrow-Clark VectorFlow Antegrade and Retrograde Chronic Hemodialysis Catheters, the Cannon II Plus Chronic Hemodialysis Catheter, and the NextStep Antegrade and Retrograde Chronic Hemodialysis Catheters. The FDA links to a full list of affected lots.

In April, Arrow sent affected customers a letter telling them to immediately stop use and distribution of the affected kits and sets and to return them to the company, according to the FDA. The agency's notice says not to use Merit Medical 16F Dual-Valved Splittable Sheath Introducers in the Arrow kits and sets. Customer questions go to Teleflex Customer Service, the notice says.

A component recall upstream

Arrow's action follows Merit Medical's own recall of the introducer, which the FDA posted on April 14. "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," the alert says.

The introducer is packaged within the sterile barrier of the finished Arrow kits and is used to deliver the catheter into the vascular system, according to the FDA. The agency said failure of the 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," the FDA said. "As of April 21, Arrow International has not reported any additional patient injuries or deaths."

The AHA item also noted a separate FDA Early Alert for Omnicell i.v.STATION sterile labels, which Omnicell has told customers not to use.