The FDA is warning consumers that Unomedical A/S’s October 11, 2023 recall of its VariSoft Infusion Sets has been labeled Class I, the most serious type, because use of the device could result in major injuries or death.
The recall covers 13,069 boxes of VariSoft Infusion Infusion Sets (each box containing 10 sets) that were manufactured by Unomedical A/S between April 1, 2022 and August 1, 2023. Affected products were distributed across the U.S. from October 25, 2022 to September 15, 2023, and fall under model numbers 1002827, 1002828, 1002830, and under the following lot numbers: 5388367, 5388357, 5388371, 5388362, 5388368, 5388366, 5388372, 5388376. Consumers should note that the lot number can be found “next to the symbol on the box and pouch labels.”
Meant to be used with Tandem insulin pumps, Varisoft Infusion Sets facilitate the subcutaneous infusion of insulin during diabetes treatment. Delivered sterile and ready to use, the set’s 20 to 45-degree insertion angle allows users to personalize an insertion angle to their own comfort. This feature makes the device preferable among those who are thin or those who have scar tissue that limits available insertion sites.
Unomedical A/S took action after it was discovered that the connector could detach from the infusion set, which would disrupt insulin delivery to a patient. In this event, insulin may proceed to travel through the disconnected tube, and the insulin pump would not be able to register the problem in the infusion set. As a result, users would not be alerted.
Further investigation determined that the damage to the connector piece occurred during the manufacturing process, causing a situation in which the connector becomes more easily detached from the insulin set than anticipated. Those who experienced disconnections during sleep, or in other circumstances where the problem goes unnoticed, are at particular risk of hyperglycemia if the connector is not promptly re-attached.
Officials have identified that use of devices from the recalled lots pose a risk of death or a life-threatening situation to patients. Such cases would require immediate medical attention.
To date, Unomedical A/S has received 1 report of injury, and no reports of death, in connection to the recall.
The recall announcement identifies patients who use the affected VariSoft Infusion Sets with the Tandem insulin pump as those who may be affected, but in particular:
- Children and elderly individuals who either fail to notice the connector is detached, or who are unable to communicate that it’s been disconnected or that they’re experiencing hyperglycemia symptoms
- Children or active sleepers, who are more likely to experience disconnection that goes unnoticed during sleep
- Pregnant women, as well as their growing fetus
Unomedical A/S issued an Urgent Field Safety Notice to Tandem Diabetes Care, their only co-signee, on October 11, 2023, prompting them to alert customers on October 25, 2023. Customers were asked to
- avoid using any affected VariSoft Infusion Sets and alert Tandem Customer Technical Support by email or phone.
- Tandem will then help carry out a return of the item and ship a replacement product(s).
- a healthcare provider should be consulted for guidance and immediate replenishment in the event that all available stock is under affected lot numbers.
- review and acknowledge receipt of the communication by sending an email to Tandem Customer Technical Support via Techsupport@tandemdiabetes.com or by calling 1-877-801-6901.
As the FDA continues to monitor the recall, healthcare providers and consumers are encouraged to refer to the agency’s MedWatch program to report any adverse events or quality issues related to the product.
If you’ve suffered an adverse health event or outcome that can be traced to the use of a compromised medical device, we would like to help you fight for maximum compensation. Our compassionate attorneys at TruLaw are experienced in helping people like you hold negligent parties responsible. Connect with us online or try out our free Instant Case Evaluation ℠.