Z-1344-2022 Class II Ongoing
FDA device recall Z-1344-2022 was initiated by Abbott on June 9, 2022 and is designated Class II. 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.… The recall status is ongoing. Affected quantity: 191 devices.
Recall Details
- Product Type
- Devices
- Report Date
- July 13, 2022
- Initiation Date
- June 9, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 191 devices
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."
Distribution Pattern
US Nationwide distribution.
Code Information
UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811