FDA gives Class I recall rating to insulin infusion sets used with Tandem pumps

The tubing used to subcutaneously deliver insulin from a Tandem Diabetes Care pump is among the latest devices to land in the FDA’s hot seat.

Unomedical A/S began a recall of some of its VariSoft infusion sets in October, and in a notice this week the FDA gave the recall its most serious rating, Class I, signifying a high risk of injury or death associated with the affected devices.

While most infusion sets require their needle or cannula to be inserted under a user’s skin at either a 90- or 30-degree angle, the VariSoft version is more flexible and can be put in place at an insertion angle anywhere between 20 and 45 degrees. According to the FDA, that makes VariSoft’s tubing preferable to people “who are thin or who have scar tissue or limiting potential insertion sites.”

The VariSoft infusion sets are only used with insulin pumps from Tandem. Unomedical kicked off the recall in October by sending an urgent field safety notice to the insulin pump maker, which in turn began notifying its customers of the recall by the end of the month.

The safety alert stems from Unomedical’s discovery that the connector—which links the VariSoft tubing to a user’s body—could detach from the infusion set, preventing insulin from reaching the user. If that happens, the insulin pump won’t recognize any issues with the mechanism and will continue sending insulin through the tubing without alerting the user to any delivery issues.

Because of that lack of alerts, the connector piece issue can be especially dangerous to users who are sleeping or otherwise not paying attention to their insulin delivery and blood sugar levels, putting them at risk of hyperglycemia, which can in turn lead to life-threatening complications.

To date, according to the FDA notice, there has been one report of injury related to the recall, with no reported deaths.

Unomedical has traced the issue back to damage that some of the connectors may have incurred during the manufacturing process.

The recall comprises only certain model and lot numbers of the VariSoft infusion sets that were manufactured between April 1 and August 1 of 2022, then distributed between late October of that year and mid-September of this year. In the U.S., that comes out to more than 130,000 infusion sets, which are sold in boxes of 10.

Tandem has asked people who use the VariSoft tubing with its insulin pumps to stop using the recalled infusion sets and notify the company, which will organize a return of the potentially defective devices and send out replacements. If all of a user’s available infusion sets are from the affected lots, they should immediately contact their healthcare provider to secure replacements in the meantime.