FDA MedWatch Safety AlertsOriginal article
Early Alert: Angiographic Catheter Issue from Boston Scientific
RegulatoryImager II Angiographic CathetersNegative
AI Analysis
Summary
Boston Scientific has removed Imager II Angiographic Catheters from the market due to a manufacturing defect that can cause tip detachment, potentially resulting in procedural delays and embolism complications.
Outcome Details
Product removal due to manufacturing defect causing tip detachment
Importance:7/10
Sentiment:
-0.90
product recallmanufacturing defectmedical devicesafety issueFDA MedWatchangiographic catheter
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Published by FDA MedWatch Safety Alerts on August 28, 2026 4:00 AM