Reported May 22, 2024 · Ongoing
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
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 · 1 Scimed Pl · Maple Grove, MN · 55311-1565
Is this the product you have?
Expo 5F Selective Angiographic CathetersMODEL - 5F EXPO FL4.5 (5PK)REF H74908526232cardiac catheter
- Lot codes and dates
- UDI/DI 08714729187837
- Batch Numbers
604439286045712360464496604731886050488860522597604773056051733760533589
- Amount recalled
- 4715 catheters
This recall covers 48 products
The agency filed one notice per product. You are reading one of them; the other 47 are below.
35 more are in the archive.
Why it was recalled
Stop using this product now
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
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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