Tag: medtronic

Medtronic Issues Early Alert for Bravo CF Capsule Delivery Devices Over Serious Injury Risks

27 Aug 2026 11:20 a.m. · Source: US Food and Drug Administration

Medtronic and Given Imaging issued an Early Alert for Bravo CF capsule delivery devices, citing risks of attachment/detachment failure. This issue has led to 184 serious injuries, prompting a recommendation for device removal due to deployment control problems.

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FDA Issues Class I Recall for Medtronic Harmony Delivery Catheter System

13 Jul 2026 3:19 p.m. · Source: US Food and Drug Administration

Medtronic's Harmony Delivery Catheter System faces a Class I recall by the FDA due to a risk of distal tip detachment. This serious issue could require secondary intervention and poses significant patient risks, though no serious injuries or deaths are…

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