[Recalled] MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transsepta
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | MEDTRONIC ARRIVE BRAIDED TRANSSEPTAL SHEATH 10F C70¿ S61CM D66CM GLOBAL Catalog # 990061-070-000 Is designed to facilitate the introduction of catheters to any of the heart chambers, including the left atrium via a transseptal puncture. |
|---|---|
| Brand / manufacturer | Oscor, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0812-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 05 October 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Complaint that during insertion of the dilator through the sheath a fragment of inner liner came out of the sheath prior to use.
This Class II 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
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Oscor, Inc.
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.