The FDA announced today that it deemed Boston Scientific’s recall of its VICI SDS and VICI RDS venous stent systems as Class I, the most serious kind of recall.
Marlborough, Mass.-based Boston Scientific’s VICI SDS and VICI RDS venous stent systems treat obstructions and occlusions in narrowed or blocked venous veins. According to the FDA notice, the company recalled the stent systems following reports indicating that they may migrate or move from where they are initially implanted.
To date, there have been 17 complaints and reported injuries related to the issue of migration with the stents. No deaths have been reported, however.
Boston Scientific initiated the recall on April 12, 2021, with 31,798 affected devices distributed between Sep. 21, 2018, and April 9, 2021, included in the U.S. recall.
If a stent migrates or moves from the initial implant location, it may require another surgery or catheter procedure to retrieve it, increasing the risk to the patient. Risks involved in this issue include possible damage to the blood vessel, heart walls or other organs, while migration of the stent to the heart could cause life-threatening injury, FDA said.
The company’s urgent medical device recall notification told customers to immediately discontinue use of the device, remove all affected units from inventory and secure them and complete the process of acknowledging the receipt of affected products and arranging for their return to Boston Scientific.
“Boston Scientific voluntarily initiated a global removal of all non-implanted VICI and VICI RDS venous stent systems in April 2021 due to customer reports of stent migration after stent implantation,” the company said in a statement emailed to MassDevice. “This product removal was recently classified by the FDA. While the rate of occurrence was extremely low at 0.08%, we took this action to uphold the highest standards of patient safety.”