TactiFlex Ablation Catheter Not Properly Recognized by EnSiteX EP System
The TactiFlex Ablation Catheter is not correctly recognized by the EnSiteX EP System, which displays it as a different model, prevents certain features from appearing, and may show an inverted image.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device for cardiac ablation procedures where the system recognition failure and missing feature display could affect procedural safety. Meets the 'risk-of-harm products where injury has not yet been reported' criterion.
Plain-English summary
The TactiFlex Ablation Sensor Enabled Ablation Catheter (Models A-TFSE-FJ, with 7.5 F shaft and 8F distal section) is being recalled. Manufactured by St. Jude Medical, Atrial Fibrillation Division, Inc., this sterile medical device is used in ablation procedures.
When used with the EnSiteX EP System, the system does not correctly recognize the catheter model and instead displays it as a different model. As a result, certain features specific to the TactiFlex catheter do not appear on the display, and the catheter image may appear inverted.
The recall affects 483 units with lot numbers 10073391, 10075618, 10080798, 10086492, 10087953, 10089624, 10092157, 10093066, and 10095363, all expiring on 11/30/2024. Distribution includes the United States and Canada.
The recalled product
- Product
- TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.
- Manufacturer
- St. Jude Medical, Atrial Fibrillation Division, Inc.
- Hazard
- device-misidentification
- display-defect
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 (11)
- Lot numbers 10073391
- 10075618
- 10080798
- 10086492
- 10087953
- 10089624
- 10092157
- 10093066
- and 10095363
- Exp. 11/30/2024
- GTIN 05415067034618.
Distribution
Distributed nationwide across the United States.
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