Boston Scientific Contour VL Ureteral Stent Set 6FX22-30CM with .035 Sensor UPN: M006180156080 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

An increase in the rate of complaints for difficulty or inability to track over the guidewire, may result in a procedural delay due to the need to exchange the affected device

Recommended Action

Per FDA guidance

Boston Scientific issued Customer Notification on March 9, 2020 stating reason for recall, health risk and action to take: cease distribution or use of any remaining product affected by this removal should cease immediately; Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Verification Form the quantity of units from each lot/batch that you will bereturning. As some of these products within these lots/batches are sold as 5-packs, it is important that all reported quantities represent the actual number of single units being returned and not the number of cartons/boxes or multi-packs; If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth is to the hospital level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital within your network, please ensure that this notification is forwarded to them.