[Recalled] 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 tip and the heart wall.
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | 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 tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrop |
|---|---|
| Brand / manufacturer | St Jude Medical |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1284-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 25 November 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from St Jude Medical
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.