Home / Recalls / Medical Devices
Medos International Sarl recalls CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe
Recalled March 20, 2024 · FDA recall Z-1284-2024 · 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. · FDA Class I
Units
1343 units
Sold at
Worldwide distribution.
Description
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.
Product
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
Manufacturer(s)
Medos International Sarl
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →