Drug recall
Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109…
FDA recall event 72739 · Class II · Boston Scientific Corporation
Key facts
| Event ID | 72739 |
|---|---|
| Recall numbers | Z-0588-2016 |
| Recalling firm | Boston Scientific Corporation |
| Product type | Devices |
| Products | Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104, 8105, 8106, 8107, 8108, 8109, 8110, 8111, 8112, 8113, 8114, 8115, 8116, 8117, 8118, and 8119. The ACUITY Pro Lead Delivery… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential for separation of the proximal handle from the shaft. |
| Initiation date | Nov 25, 2015 |
| Report date | Jan 13, 2016 |
| Termination date | Apr 8, 2016 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 2124215 |
At a glance
- 1–9 Products in this recall
- 10–99 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: