Z-1344-2022Class II

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

Name: Z-1344-2022 Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of...
Creator: Abbott
Published: 2022-06-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2022-06-09 / Open, Classified / root cause: design

FDA source

Abbott began a recall of Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation on 2022-06-09. FDA classified it as Class II and gives the reason as "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."". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1344-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-09
Posted: 2022-07-07
Recalling firm: Abbott Medical
Product: Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during ablation.
Product code: OAE Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
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."
Root cause tag: design
FDA root cause: Device Design
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."
Quantity in commerce: 191 devices
Distribution: US Nationwide distribution.
Product codes and lots: UDI 01)05415067027665(17)230831(10)xxxxxxx, Batch Numbers 8409416, 8409675, 8410811

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1344-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1344-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-13	2022-07-07

Product code OAE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)