92,827 hemodialysis catheters recalled — a component whose function is to split apart may not split (Arrow International)

1A component whose function is to break apart

A splittable sheath introducer is a temporary passage for placing a large catheter into a blood vessel. Once the catheter is through, the passage is no longer needed — but it cannot simply be pulled out, because the catheter runs through it. So it is built to be split lengthwise and peeled away to either side. Splitting is, in other words, the design function of this component.

2What happens when it does not split

The outcomes the record lists are withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, and vessel wall injury. That a single failure to split produces so long a list follows from where the problem occurs: the component is already inside the vessel. Getting a non-functioning part back out means applying force or switching technique, and either loads the vessel. That the fault reveals itself mid-procedure is what sets its weight.

392,827 units and worldwide distribution

The quantity is 92,827, among the larger device recalls this site holds as of 2026-08-28. Distribution covers the United States plus roughly 60 countries and territories, including Japan. This too is a cascade originating in a supplier recall: within our collection, 94 enforcement records across seven companies state a supplier-recall origin.

4What device recalls give as their reason

Of the FDA recall records this site holds as of 2026-09-01, 779 are devices. Counting the words that appear in their reasons gives incorrect in 63, leak in 59, sterility in 52, labeling in 51, seal and crack in 39 each, detach in 33 and software in 26.

What leads the list are physical failures — a part that cannot hold its intended form. A case like this one, where a component meant to split apart does not, belongs to a type peculiar to devices: the fault is not breaking but failing to behave as designed.