FDA Device recall Z-1284-2024
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD
- FDA Device
- Class I
- ongoing
- Published 2024-03-20
On 2024-03-20 the FDA classified a Class I recall of CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD by Medos International Sarl, citing 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 inju….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1284-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-02-02 |
| Published | 2024-03-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medos International Sarl |
| Distribution | n/a |
Product
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.
Identifiers
| code_info | a) GS9080SD: UPDATED 4/4/2024 UDI-DI 10886704082316, Lot numbers: 31121042, 31133636, 31140739, 31140751, 31146719,…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1284-2024%22
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