Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart c

FDA device recall Z-1344-2022 · posted 2022-07-07 · Open, Classified

Recall details

Recalling firm

Abbott

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."

Action taken

The firm notified its consignees by hand delivered Medical Device Recall letter on 06/09/2022. The letter explained the problem and provided the following instructions: "Next Steps To help reduce risk, we recommend: " Do not use any remaining inventory from the affected lots listed in Appendix A. " Complete and return the accompanying Acknowledgement Form to Abbott. " Return all remaining unused affected devices to Abbott. Your Abbott representative can assist you in returning these devices and obtaining replacements. Please forward this notice to anyone within your organization who may need to be notified and maintain a record of this notice along with a copy of the completed Acknowledgement Form for your records."

Root cause

Device Design

Status

Open, Classified

Product code

OAE

Quantity affected

191 devices

Distribution

US Nationwide distribution.

Date initiated

2022-06-09

Date posted

2022-07-07

Location

Plymouth, MN