Reported Apr 3, 2024 · Ongoing
Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
Boston Scientific Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N · Saint Paul, MN · 55112-5700
Is this the product you have?
- Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
- Lot codes and dates
- GTIN 08714729992684
- Batch Numbers
328959453289594732903274329032753290327632903277329032783290334032999267330003313300033333000334330003373300033833000339330526463305264733052648330526493306157633171976
- Amount recalled
- 461 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Why it was recalled
Stop using this product now
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).
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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