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Terminated

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

FDA Recall Z-1344-2022 · Posted 2022-07-07

Recalling FirmAbbott
Recall StatusTerminated
Product CodeOAE
Date Initiated2022-06-09
Date Terminated2026-08-14
Product Quantity191 devices

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."

Firm Action

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

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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