Boston Scientific Guider Softip XF Guide Catheter Recalled for Polymer Degradation
Boston Scientific is recalling Guider Softip XF Guide Catheters due to potential polymer material degradation. The recall affects 31,005 units distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device defect (polymer degradation) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling the Guider Softip XF Guide Catheter, a neurovascular access device used to create a stable conduit for interventional devices. The recall is being conducted due to potential polymer material degradation.
A total of 31,005 units are affected by this recall. The devices were distributed nationwide in the United States and in Canada. Specific states listed for distribution include Alabama, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, New York, Ohio, Oregon, Tennessee, Texas, Utah, and Washington.
The source text does not specify the corrective action required for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect. Users should refer to the official FDA recall notice for specific instructions on how to handle the affected devices.
The recalled product
- Product
- Boston Scientific Guider Softip XF Guide Catheter Product Usage: Is a neurovascular access catheter that creates a stable conduit through which interventional devices can pass. It is constructed with a polymer liner on the inside diameter for lubricity, stainless steel wire…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 31,005
Distribution
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