Abbott TactiCath Ablation Catheter System Error Display Malfunction
Abbott recalls 191 TactiCath cardiac ablation catheters that may display incorrect error messages when connected to the EnSite Precision Navigation System, potentially causing user confusion.
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 3/5 (High).
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: FDA Class II recall with no reported injuries or illnesses. The error message malfunction represents a risk-of-harm scenario for critical cardiac procedures, meeting the severity 3 (High) criteria.
Plain-English summary
Abbott is recalling 191 TactiCath Sensor Enabled, Contact Force Ablation Catheters (model 8F 115cm FJ, reference A-TCSE-FJ) distributed nationwide in the United States. These catheters are used for mapping of the heart chambers during cardiac ablation procedures.
When connected to the EnSite Precision Navigation System, affected catheters may display error messages stating "invalid catheter" or "expired catheter."
Affected devices can be identified by batch numbers 8409416, 8409675, and 8410811, along with the UDI (Unique Device Identifier) 01)05415067027665(17)230831(10).
The recalled product
- Product
- Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
- Manufacturer
- Abbott
- Affected units
- 191
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 (4)
- UDI 01)05415067027665(17)230831(10)xxxxxxx
- Batch Numbers 8409416
- 8409675
- 8410811
Distribution
Distributed nationwide across the United States.
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