CERENOVUS CEREBASE DA Guide Sheath — Class I medical device recall Z-1284-2024
Ongoing recall by Medos International Sarl, reported 2024-03-20. Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the dis
| Recall number | Z-1284-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medos International Sarl, Le Locle, N/A, Switzerland |
| Recall initiated | 2024-02-02 |
| Classified | 2024-03-13 |
| Reported by FDA | 2024-03-20 |
| Quantity | 1,343 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 10886704082293, 10886704082316, 10886704082323 |
| Lot numbers | 31094249, 31103843, 31108260, 31116484, 31116485, 31121039, 31121040, 31121042, 31121043, 31121044, 31133636, 31133637, 31133638, 31140739, 31140740, 31140751, 31140952, 31146719, 31146720, 31150968, 31150969, 31154809, 31154810, 31154811, 31160736, 31160737, 31160738, 31168610, 31168611, 31174927, 31174928, 31174930, 31178955, 31178956, 31178957, 31178958, 31189206, 31189207, 31189208, 31194710 and 18 more |
Product
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1284-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.