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Boston Scientific Corporation recalls Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Recalled April 3, 2024 · FDA recall Z-1302-2024 · Boston Scientific
Hazard
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 of the sheath or introduction of the dilator or ablation catheter). · FDA Class I
Units
461 devices
Sold at
Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
Description
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 of the sheath or introduction of the dilator or ablation catheter).
Product
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →