Medos International Sarl recalls CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, singl…

Recall date

February 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1284-2024

FDA classification

Class I

Brand / firm

Medos International Sarl

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use