QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; 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 00827002227675 (each), 10827002227672 (case), Lot Numbers: W4739833, W4749234, W4750262, W4756463, W4756465, W4720843, W4722160, W4722641, W4723307, W4724321, W4739835, W4740109, W4740421, W4746519, W4747434, W4748249, W4749510, W4749744, W4750867, W4751104, W4751904, W4752276, W4752565, W4752902, W4752908, W4755364, W4756899, W4757275, W4758645, W4759509, W4760713, W4761742, W4761743

Distribution pattern: US