Drug recall
Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions…
FDA recall event 71881 · Class II · Volcano Corporation
Key facts
| Event ID | 71881 |
|---|---|
| Recall numbers | Z-2718-2015 |
| Recalling firm | Volcano Corporation |
| Product type | Devices |
| Products | Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for Crossing Total Occlusions. Cardiovascular: The Volcano Pioneer Plus Intravascular Ultrasound Re-Entry Catheter (Pioneer Plus)… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a manufacturing defect, there is the possibility that a small wire could extend through the catheter shaft of the Pioneer Plus intravascular Ultrasound Guided Re-Entry Catheters. |
| Initiation date | Jul 22, 2015 |
| Report date | Sep 9, 2015 |
| Termination date | Apr 28, 2016 |
| City | Rancho Cordova |
| State | CA |
| Country | United States |
| FEI number | 2939520 |
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: