HIGH

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Quick Facts at a Glance

Recall Date
September 10, 2025
Hazard Level
HIGH
Brand
Abbott

Hazard Information

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Abbott or your healthcare provider for instructions. Notification method: Letter

Full Description

TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter. Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.. Classification: Class I. Quantity: 3403 units. Distribution: Worldwide

View Original Recall on FDA - Medical Devices

Want Alerts Like This?

Get notified about recalls in categories you care about.

Product Classification

Product Details

Brand
Abbott
Model Numbers
GTIN 05415067034557
Batch Numbers: 8843948
8855039
8906316
8913730
+15 more
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more