Drug recall
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to…
FDA recall event 70727 · Class I · Cardiovascular Systems, Inc.
Key facts
| Event ID | 70727 |
|---|---|
| Recall numbers | Z-1290-2015 |
| Recalling firm | Cardiovascular Systems, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Mar 4, 2015 |
| Report date | Apr 1, 2015 |
| Termination date | Apr 26, 2016 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 3004742232 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: