St. Jude Medical Recalls Electrophysiology Catheters Due to Incorrect Packaging
St. Jude Medical is voluntarily recalling 26 electrophysiology catheters because the packaging contains the wrong device model. No serious injuries have been reported.
The agency’s classification
FDA (Devices): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a voluntary precautionary recall involving a labeling/packaging error where no injuries have been reported, fitting the criteria for a moderate severity score.
Plain-English summary
St. Jude Medical is performing a voluntary recall of 26 units of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter, Model 401353, Batch # 4671318. The recall was initiated because the firm identified that every device packaged within this specific batch contains the incorrect catheter (Supreme FC QUAD 5F catheter) inside the packaging.
The affected devices were distributed in the United States, including the states of California, Georgia, New Jersey, New York, Oregon, and Pennsylvania. To date, no serious injuries have occurred as a result of this issue.
Healthcare providers and consumers should stop using the affected catheters and contact St. Jude Medical for further instructions on how to return or replace the devices.
The recalled product
- Product
- St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
- Manufacturer
- St Jude Medical
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 26
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch # 4671318
Distribution
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