Recall Z-1344-2022— Abbott
Class II · Ongoing
Class II FDA medical device recall by Abbott, initiated 2022-06-09. FDA's recall record names no specific 510(k) clearance for this event. Product: Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.. Reason: When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter.".
- Recalling firm
- Abbott
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-09
- Firm location
- Plymouth, MN, United States
Product description
Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Reason for recall
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
Data sourced from openFDA. This site is unofficial and independent of the FDA.