Abbott: Medical Device Recall in 2022 - (Recall #: Z-1344-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 9, 2022

Date Posted: July 13, 2022

Recall Number: Z-1344-2022

Event ID: 90414

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."

Status: Ongoing

Product Quantity: 191 devices

Code Information:

UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated