Thoracic Stent Graft Recall

1 recall on record · Last recall: May 20, 2026

Safety Score

97/100

Excellent

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

Class I — Serious

Class II — Moderate

Class III — Low Risk

Unclassified

FDAMay 20, 2026

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

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