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Early Alert

1 recall on record · Last recall: Apr 28, 2026

Safety Score

97/100

Excellent

Based on recall frequency and severity over the past 3 years, with older recalls weighted less.

Severity Breakdown

Class I — Serious
0
Class II — Moderate
0
Class III — Low Risk
0
Unclassified
1

Categories

MEDICATION

Recall Timeline

FDAApr 28, 2026

Early Alert: Thoracic Stent Graft Issue from Bolton Medical

Affected grafts may not unclasp from the delivery system, which may require conversion to open surgical repair and can result in patient death

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