[Recalled] Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stentin
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions. |
|---|---|
| Brand / manufacturer | Cardiovascular Systems, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1290-2015 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 04 March 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
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 →
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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.