Reported Jan 31, 2024 · Ongoing
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
St. Jude Medical, Atrial Fibrillation Division, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: St. Jude Medical, Atrial Fibrillation Division, Inc. · 1 Saint Jude Medical Dr · Saint Paul, MN · 55117-1789
Is this the product you have?
- TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
- Lot codes and dates
Lot numbers 1007339110075618100807981008649210087953100896241009215710093066and 10095363Exp. 11/30/2024GTIN 05415067034618
- Amount recalled
- 483 units
Where it was sold
Why it was recalled
When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.
This product could cause temporary or reversible health problems — stop using it.
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