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

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution. Quantity: 1343 units Lot/code info: 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

UPC codes

10886704082316, 10886704082293, 10886704082323

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.