[Recalled] Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blo
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle. |
|---|---|
| Brand / manufacturer | Arrow International, Inc., Division of Teleflex Medical Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1056-2016 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 10 February 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.
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 Arrow International, Inc., Division of Teleflex Medical 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.