Drug recall
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac…
FDA recall event 70490 · Class II · St Jude Medical
Key facts
| Event ID | 70490 |
|---|---|
| Recall numbers | Z-1284-2015 |
| Recalling firm | St Jude Medical |
| Product type | Devices |
| Products | TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters. |
| Initiation date | Nov 25, 2014 |
| Report date | Mar 25, 2015 |
| Termination date | May 6, 2015 |
| City | Saint Paul |
| State | MN |
| Country | United States |
| FEI number | 3007562768 |
At a glance
- 1–9 Products in this recall
- None 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: