St Jude Medical St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Brand
St Jude Medical
Lot Codes / Batch Numbers
Batch # 4671318
Products Sold
Batch # 4671318
St Jude Medical is recalling St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353 due to 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. Spe. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, GA, NJ, NY, OR, PA
Page updated: Jan 10, 2026