QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3-E, Order Number G22765; used to dilate strictures of the biliary tree

Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

Code information: UDI/DI 00827002227651 (each), 10827002227658 (case), Lot Numbers: W4721269, W4721794, W4722640, W4722986, W4723306, W4723844, W4723847, W4724322, W4739837, W4740113, W4742111, W4742513, W4742524, W4743194, W4743197, W4744442, W4744872, W4744873, W4748250, W4751513, W4751773, W4752903, W4753813, W4753820, W4753821, W4754252, W4755365, W4756464, W4756475, W4757731, W4757734, W4758163, W4758168, W4758649, W4758931, W4759974, W4759978, W4760297, W4760463, W4760464, W4760466, W4760720, W4760859, W4761739, W4761741, W4762144, W4762624

Distribution pattern: US