Class I — Medos International Sarl
| Recalling firm | Medos International SARL |
|---|---|
| Registered facility | MEDOS INTERNATIONAL SARL (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| 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. |
| Product | CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use |
| Quantity | 1343 units |
| Distribution | Worldwide distribution. |
| Initiated | 2024-02-02 |
| Classified | 2024-03-13 |
| Recall number | Z-1284-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Medos International Sarl (Z-1284-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93955/
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