- The Food and Drug Administration has categorized Unomedical’s recall of VariSoft infusion sets as a Class I event.
- Unomedical, working with its partner Tandem Diabetes Care, contacted customers last month to warn them not to use certain lots of its infusion sets because of a defect that can disrupt insulin delivery.
- The recall affects 13,069 boxes, each of which contains 10 infusion sets, and has been linked to one reported injury and no deaths. Disrupted insulin delivery could cause hyperglycemia and potentially death.
Unomedical, a Danish subsidiary of the medtech company Convatec, sells VariSoft infusion sets for use with Tandem insulin pumps. According to the FDA, the VariSoft products allow users to choose the angle at which they insert the infusion sets. The devices are “often preferred by users who are thin or who have scar tissue or limiting potential insertion sites,” the FDA said Monday.
The recall stems from damage to the connector piece during manufacturing. The damage means that the connector can become detached from the insulin set more easily. Disconnections that happen while the patient is asleep, or otherwise unable to detect the problem, may lead to excess glucose in the blood.
“There is a chance of death or life-threatening harm to individual patients using devices from these lots, requiring professional medical intervention,” the FDA wrote.
Unomedical sent an urgent field safety notice to Tandem on Oct. 11, and Tandem began notifying customers on Oct. 25, according to the FDA. The notice asked customers not to use affected VariSoft infusion sets. If a user only has affected lots, they should contact their “healthcare provider for guidance and instant replenishment,” the agency said.
Convatec sent a patient recall notice to Canadian customers on Oct. 19. The notice warns that “infants and children with increased nighttime movement activity may be more at risk.” That risk is mitigated by the fact that “infusion would take place under the supervision of a parent, guardian or caregiver,” Convatec said. Similarly, while critically ill people are at risk, Convatec presumes extra precautions will be in place.