Reported Apr 3, 2024 · Ongoing
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
- Lot codes and dates
- GTIN 08714729950660
- Batch Numbers
120 of 120 codes
313680413139008431390088313900893150186631501867315018683150186931520897315208983160449231616143316336353165045731664216316642173167114031671143316936383169363931724952317329303173293131740806317408073174080831751118317771343178658231786583318182903181829931818341318183423181834331818344318183453181834631818347318386843183868531838686318386873183868831838689318773023187730431877305318773063190474831904749319237553192375631953345319533483200817032031191320311923203119332031196
- Amount recalled
- 4060 devices
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
This product could cause temporary or reversible health problems — stop using it.
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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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