FDA (Devices) recall action 93326
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Wilson-Cook Medical is recalling 157 Quantum TTC Biliary Balloon Dilator devices due to a design defect that may cause balloon detachment during use, potentially requiring emergency retrieval.
Wilson-Cook Medical recalled 731 QUANTUM TTC biliary balloon dilators due to design nonconformity that could cause balloon detachment. The device failure may require endoscopic retrieval and risks bleeding complications.
Wilson-Cook Medical is recalling 941 biliary balloon dilators that may detach during use. Detachment could require doctors to retrieve the device with an endoscope, which may cause bleeding.
Wilson-Cook Medical is recalling QUANTUM TTC biliary balloon dilators due to design non-conformance. The devices may detach during use, potentially requiring endoscopic retrieval that could cause bleeding.
Wilson-Cook Medical recalls 553 Quantum TTC Biliary Balloon Dilators that do not meet design specifications, creating risk of balloon detachment during endoscopic procedures.
Wilson-Cook Medical Inc. is recalling 888 units of the Quantum TTC Biliary Balloon Dilator due to design nonconformance that could cause balloon detachment during use, potentially requiring endoscopic retrieval or causing bleeding.
Wilson-Cook Medical is recalling QUANTUM TTC BILIARY BALLOON DILATORS due to nonconforming devices that may detach during use. Detachment could require endoscopic retrieval and carries a risk of bleeding.