Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
RegulatoryrejectedRelay Pro SystemNegative
AI Analysis
Summary
Bolton Medical issued a recall of the Relay Pro thoracic stent graft system due to a malfunction where grafts may fail to unclasp from the delivery system, potentially necessitating open surgical repair and posing fatal risks to patients.
Outcome Details
Product recall due to defect where grafts may not unclasp from delivery system, potentially requiring conversion to open surgical repair and risking patient death
Importance:8/10
Sentiment:
-1.00
recallmedical devicesafety issuethoracic stent graftFDA MedWatch
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Published by FDA MedWatch Safety Alerts on July 17, 2026 4:00 AM