QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3-E, Order Number G22766; 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 00827002227668 (each), 10827002227665 (case), Lot Numbers: W4756462, W4756900, W4720847, W4722980, W4723309, W4723843, W4724323, W4739834, W4739836, W4740110, W4746517, W4748042, W4749743, W4750261, W4750868, W4751105, W4751508, W4751913, W4752281, W4752574, W4753814, W4754251, W4754849, W4756902, W4757276, W4757730, W4757733, W4758164, W4758169, W4758646, W4759510, W4759975, W4761222, W4761227, W4762146, W4762152, W4762386, W4762626

Distribution pattern: US