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

Reason: 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.

Code information: a) GS9080SD: UPDATED 4/4/2024 UDI-DI 10886704082316, Lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719, 31154809, 31160736, 31174927, 31178955, 31189206, 31194710, 31194733, 31208988, 31212653, 31212661; b) GS9090SD: UPDATED 4/4/2024 UDI-DI 10886704082293, Lot numbers: 31094249, 31103843, 31108260, 31116484, 31116485, 31121039, 31121040, 31121043, 31121044, 31133637, 31133638, 31140740, 31140952, 31146720, 31150968, 31150969, 31154810, 31154811, 31160737, 31160738, 31168610, 31168611, 31174928, 31174930, 31178956, 31178957, 31178958, 31189207, 31189208, 31194711, 31194712, 31194734, 31194735, 31204436, 31208989, 31208990, 31208991, 31212654, 31212655, 31212663, 31225738; c) GS9095SD: UDI-DI 10886704082323, Lot Numbers: 31208992, 31212656

Distribution pattern: Worldwide distribution.