Unomedical’s VariSoft Insulin Infusion Faces FDA Class I Recall
In a year marked by a string of medical device recalls, Unomedical has joined the ranks of companies facing a Class I recall by the US Food and Drug Administration (FDA) due to issues with its VariSoft infusion sets. These crucial devices are utilized with insulin pumps manufactured by Tandem Diabetes, a US-based company, to administer insulin subcutaneously to patients living with diabetes. A manufacturing glitch in Unomedical’s infusion set has raised a significant concern – the potential detachment of the connector, which can disrupt insulin delivery from the pump, as highlighted in an FDA alert.
A Class I recall signifies that the defect has the potential to cause severe injury or even death. To date, only one injury has been reported. In response to this issue, Unomedical initiated the recall in October 2023, with approximately 13,000 boxes of devices, each containing ten sets, being recalled in the United States. The connector damage affects eight batches of lot numbers produced between April and August 2022.
The FDA has stressed that if the connector were to detach during sleep or in situations unnoticed by the patient, it could lead to hyperglycemia. Instead of insulin reaching the patient, it would flow through the disconnected tubing, but fortunately, the pump is designed to detect such problems.
Unomedical’s infusion sets offer a valuable solution to patients with limited potential insertion sites or scar tissue, as they provide a larger insertion angle compared to traditional needles or cannulas. However, this recent manufacturing issue has prompted concerns about their safety and effectiveness.
Following Unomedical’s issuance of an urgent field safety notice to Tandem, the pump manufacturer promptly informed its customers to cease using the affected sets and pledged to facilitate their return.
The year 2023 has seen a significant uptick in medical device recalls, with many classified as Class I recalls – the most severe category. A report by Sedgwick revealed that recalls have reached a four-year high, with manufacturing defects emerging as a leading cause behind the surge in recall levels.
The diabetes device sector, in particular, has encountered high-profile challenges this year. Insulet reported a data breach affecting 29,000 of its insulin pump users, while Abbott received an FDA warning in April due to concerns that its glucose monitors could pose a fire hazard.
Furthermore, Medtronic, the medtech giant, has faced multiple lawsuits in connection with the failure of its MiniMed insulin pumps. These pumps have experienced several recalls over the past decade and may have resulted in more than 2,000 injuries and one fatality.
Filing Your VariSoft Insulin Infusion Product Liability Lawsuit
For individuals who may have experienced harm or injury as a result of this recall, pursuing a product liability lawsuit could be a viable option to seek compensation. Such lawsuits involve several key steps, each of which underscores the critical role of legal representation. Victims should begin by consulting with an attorney to assess the merits of their case and gather necessary evidence establishing the link between the product defect and the injuries sustained.
Subsequently, the lawsuit should be formally filed, naming Unomedical as the defendant. The discovery process follows, involving the exchange of vital information and evidence between both parties. Attorneys play a crucial role in negotiating potential settlements, but if a fair resolution cannot be reached, they will advocate for the case in court.
Throughout this legal journey, having an attorney is essential. Product liability cases are complex and require legal expertise to navigate successfully. Attorneys safeguard victims’ rights, secure crucial evidence, and tirelessly fight for just compensation.
In a product liability lawsuit concerning injuries caused by a defective medical device, potential damages that victims may recover include compensation for medical expenses, pain and suffering, emotional distress, lost wages, and other related losses. The extent of these damages depends on the severity of the injuries and the specific circumstances of each case.
The FDA’s Class I recall of Unomedical’s VariSoft infusion sets highlights the critical importance of safety in medical devices. For individuals impacted by this recall, pursuing a product liability lawsuit with the help of experienced attorneys may be necessary to seek compensation for damages. Parker Waichman LLP stands ready to provide expert guidance and support during these challenging times, offering a free consultation to help victims pursue justice and recover their losses.
CONTACT PARKER WAICHMAN LLP FOR A FREE CASE REVIEW
For those affected by the Unomedical VariSoft infusion set recall, seeking legal counsel from a reputable law firm is essential. Parker Waichman LLP, a national product injury law firm, is ready to provide guidance and support, offering a free consultation to victims in need of expert legal assistance. If you or a loved one has suffered harm or losses due to this issue, do not hesitate to contact them at 1-800-YOUR-LAWYER (1-800-968-7529) to access the assistance you need.
Regardless of your location or where your injury occurred, our nationwide personal injury law firm is ready to assist you.