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Class I Recall On Medtronic Embolization Device After 4 Deaths

 
• By Elizabeth Orr

The company is recalling Pipeline Vantage 021 and 027 models because they pose a higher than normal risk of failing to properly attach to blood vessel walls, which can cause thrombosis, stroke or death. The recall for 027 is a product removal and for 021 is an update to the instructions for use.

Medtronic HQ sign
• Source: Shutterstock

Medtronic is recalling two models of its Pipeline Vantage embolization device after learning of 17 injuries and four deaths linked to the products, the US Food and Drug Administration announced Tuesday. The agency has deemed the recall Class I, its highest-risk designation.

The recall for 027 is a product removal and for 021 is an update to the instructions for use.

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Class I Recall On Medtronic Embolization Device After 4 Deaths

 
• By Elizabeth Orr

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