Thoracic Stent Graft Recall

1 recall on record · Last recall: Jul 17, 2026

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Records, not a safety rating.

Recall counts do not account for sales volume, exposure or differences in reporting. Agency records can overlap. A low count does not establish that a brand or product is safe.

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Severity Breakdown

Class I — Serious

Class II — Moderate

Class III — Low Risk

Unclassified

Recall Timeline

FDAJul 17, 2026

Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System

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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