Recall archive / FDA device enforcement
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, sin... — FDA record Z-1284-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 2, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class I
- Recalling firm
- Medos International Sarl
- Quantity
- 1343 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1284-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Mar 20, 2024
- Recall initiation date
- Feb 2, 2024
- Center classification date
- Mar 13, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.