FDA (Devices) recall action 94240
The FDA (Devices) publishes a recall like this one as 48 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 48 pages.
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
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.
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement. The recall affects 46,860 units distributed worldwide.
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect prevents guidewire advancement through 1065 affected devices distributed worldwide.
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that prevents guidewire advancement through the device.
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter lining, which may prevent guidewire advancement during medical procedures.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures.
Boston Scientific is recalling Expo 5F cardiac catheters due to material delamination in the inner lining that prevents guidewire advancement. The defect affects 25,617 units distributed worldwide.
Boston Scientific is recalling 8,725 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement.
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment, which may prevent proper guidewire advancement during cardiac procedures.
Boston Scientific is recalling certain Expo 5F cardiac catheters due to polyurethane layer delamination and material detachment that may prevent guidewire advancement during procedures. The recall affects 290 catheters distributed worldwide.
Boston Scientific is recalling 1,322 Expo 5F Selective Angiographic Catheters worldwide due to polyurethane layer delamination and material detachment that prevents guidewire advancement. The defect could compromise cardiac catheterization procedures.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in the inner lining. The defect prevents guidewire advancement through the catheter, compromising its function during cardiac procedures.
Expo 5F Selective Angiographic Catheters are recalled because polyurethane layer delamination and material detachment prevent guidewire advancement. Approximately 297,479 affected catheters have been distributed worldwide.
Boston Scientific Corporation is recalling Expo 5F Selective Angiographic Catheters in select batches due to polyurethane layer delamination and material detachment that could prevent guidewire advancement during use.
Boston Scientific recalls Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment in the catheter's inner lining. This prevents guidewire advancement through the catheter.
Boston Scientific is recalling 9,271 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that can prevent guidewire advancement. The defect was found in certain batches with worldwide distribution.
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Cardiac Catheters due to polyurethane delamination that prevents guidewire advancement. The recall affects 15,270 units distributed worldwide.
Boston Scientific is recalling specific batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that prevents guidewire advancement. The affected catheters may not function properly during angiographic procedures.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment that may prevent guidewire advancement. The recall affects 15,079 catheters distributed worldwide.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment that can prevent guidewire advancement during cardiac procedures. The recall affects 4,715 catheters distributed worldwide.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination in eight batches affecting 4942 units. The defect prevents guidewire advancement and could compromise device function during cardiac procedures.
Boston Scientific is recalling 8,575 Expo 5F Selective Angiographic Catheters due to polyurethane delamination that prevents guidewire advancement. The FDA Class I recall affects devices distributed worldwide.
Boston Scientific is recalling certain Expo 5F Selective Angiographic Catheters due to polyurethane layer delamination and material detachment. The defect may prevent proper guidewire advancement during cardiac procedures.
Boston Scientific is recalling certain batches of Expo 5F Selective Angiographic Catheters due to polyurethane delamination and material detachment in the catheter's inner lining, which prevents proper advancement of the guidewire.
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters due to polyurethane delamination of the inner lining. The defect prevents guidewire advancement and affects 330 units worldwide.
Boston Scientific recalls 1,015 Expo 5F selective angiographic catheters due to polyurethane layer delamination that prevents guidewire advancement. The defect affects multiple batches distributed worldwide.