FDA-Device2024-03-20Class I
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Medos International Sarl
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.
Sold states
Worldwide distribution.
Affected count
1343 units
Manufactured in
Chemin Blanc 36, N/A, Le Locle, N/A, Switzerland
Products
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1284-2024Don't want to check this manually?
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