[Recalled] St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 — St | FDA 2014-10-14
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 |
|---|---|
| Brand / manufacturer | St Jude Medical |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0177-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 14 October 2014 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identified that every device packaged within batch 4671318 contains the incorrect catheter (Supreme FC QUAD 5F catheter) within the packaging. To date, no serious injuries have occurred as a result of this issue
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.