Fusion Lithotripsy Extraction Basket

An investigation that confirmed nonconforming baskets were manufactured/distributed. This can appear in field as inability to advance or retract basket or drive wire breaking or separating from handle (with or without mechanical lithotripsy). Investigation found that bit on electric torque wrench was stripped preventing wrench from applying sufficient torque to cannula to secure drive wire. Faulty torque wrench was removed from production line and operators were retrained on torquing process.

Recall start date: July 10, 2023