FDAFebruary 2, 2024device
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
What to do
FDA enforcement status: Ongoing
Brands named
medos international sarlmedosmedos international
UPCs
108867040823161088670408229310886704082323
Recall history
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