Coloplast Pulls Ureteral Stent Kits Over ‘Packaging Anomaly’

Coloplast recalled multiple batches of its Biosoft and Vortek Duo Double Loop ureteral stent kits, citing packaging abnormalities that could jeopardize the sterility of the devices.

The devices, which are made of polyether block amide, are used for injecting saline solution and contrast agent and inserting a guidewire. Impacted devices could cause infections in patients and healthcare professionals using them must change them out, slowing down procedure time, the company said.

In total, nine batches of its Biosoft product and two batches of its Vortek product were recalled over the “packaging anomaly.” All potentially affected inventories have been placed on hold and a failure investigation is in porhas been launched.