FDA-Device2024-04-03Class I
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Boston Scientific Corporation
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).
Sold states
Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan
Affected count
461 devices
Manufactured in
4100 Hamline Ave N, N/A, Saint Paul, MN, United States
Products
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2024Don't want to check this manually?
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