[Recalled] CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use — Medos has received an increase in complaints for CEREBASE DA Guide Sheath with… | FDA 2024-
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-use |
|---|---|
| Brand / manufacturer | Medos International Sarl |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1284-2024 |
| Country of notice | Switzerland |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 02 February 2024 |
| EAN / barcode | 10886704082316 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in Switzerland and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.