Drug recall
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601…
FDA recall event 69532 · Class II · Biosense Webster, Inc.
Key facts
| Event ID | 69532 |
|---|---|
| Recall numbers | Z-0139-2015 |
| Recalling firm | Biosense Webster, Inc. |
| Product type | Devices |
| Products | ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter. |
| Initiation date | Oct 19, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Oct 6, 2015 |
| City | Irwindale |
| State | CA |
| Country | United States |
| FEI number | 3003113629 |
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: