FDA recall Z-1302-2024

Product

Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050

Reason for recall

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).

Distribution

Austria, Belarus, Estonia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Netherlands, Poland, Portugal, Spain, and Japan

Key facts

Status

Ongoing

Initiation date

2024-02-12

Report date

2024-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1302-2024