RelayPro thoracic stent-graft clasp may not release from delivery system

Plain-English summary

The RelayPro Thoracic Stent-Graft System is being recalled across a range of reference numbers and sizes listed in the recall notice. The quantity is not stated.

The action is a labeling update concerning proximal clasp disconnection from the outer control tube, which may prevent the stent graft from being released from the delivery system. The FDA classified the action as Class I, its most serious classification.

Distribution was worldwide, including the US Territory of Puerto Rico and a number of other countries. The systems are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the reference numbers and device identifiers in the recall notice and follow the updated labeling and instructions issued by the manufacturer.

The recalled product

Product

RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-N4-34-109-34U 28-N4-34-154-30U 28-N4-34-154-34U 28-N4-34-209-30U 28-N4-34-209-34U 28-N4-34-259-34U 28-

Manufacturer

Bolton Medical Inc.

Category

Medical Device — Thoracic stent graft

Hazard

• deployment-failure
• clasp-disconnection
• class-i
• endovascular

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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