[Recalled] SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use — There is a potential for extensive loss of primary segment material exposing un… | FDA 2019-03-15
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | SHERPA NX ACTIVE GUIDING CATHETER, 6F EBU3.5 SH, .070", REF SA6EBU35SH. for cardiovascular use |
|---|---|
| Brand / manufacturer | Medtronic Vascular |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2626-2019 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 15 March 2019 |
| EAN / barcode | 00613994823564 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
This Class I recall concerns device products distributed in United States 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 →
Related recalls from Medtronic Vascular
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.