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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
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.
Class IReported ongoing
Distribution: Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably fo...
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include ad...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Japan.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include ad...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Japan.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include ad...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Japan.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include ad...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Japan.
Inability to advance the guidewire through the feeding tube during placement due to blocked lumen of the barb connector. May lead prolongation in the procedure to exchange the device for another leading to leading to a cascade of events which may include ad...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the country of Japan.
Boston Scientific has identified a tooling error in manufacturing which may have caused delamination of the inner lumen of the sheath shaft in a subset of POLARSHEATH devices. This could result in the embolization of a fragment during use (such as flushing ...
Class IReported ongoing
Distribution: Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
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.
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably foreseeable to occur, ...
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
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Checking Boston Scientific Corporation
Is there a recall on boston scientific corporation right now?
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