St. Jude Medical Recalls Ablation Catheters Due to Incorrect Instructions
St. Jude Medical is recalling 59 ablation catheters shipped with the wrong Instructions for Use (IFU). The recall covers specific batches distributed in six US states.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it involves a documentation issue (incorrect Instructions for Use) without reported injuries, illnesses, or functional device defects.
Plain-English summary
St. Jude Medical is voluntarily recalling 59 units of US Safire Duo Ablation Catheter MediGuide Enabled (REF A700240) and Cool Path Duo Ablation Catheter MediGuide Enabled (REF A700244). The recall is due to a documentation error where the devices were inadvertently shipped with the incorrect version of the Instructions for Use (IFU).
The affected units are sterile, prescription-only medical devices intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator. The specific batches involved are Catalog Number A700240 Batch Number 4113242 and Catalog Number A700244 Batch Number 4113241.
Distribution was limited to Kansas, Massachusetts, Utah, Texas, Kentucky, and Ohio. Healthcare facilities and users should check their inventory for these specific catalog and batch numbers. If the affected units are found, they should be removed from service and returned to St. Jude Medical in accordance with the recall notification.
The recalled product
- Product
- US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a…
- Manufacturer
- St. Jude Medical
- Hazard
- Affected units
- 59
Distribution
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