FDA recall Z-0109-2026

Abbott · Class I · device

Product

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

Reason for recall

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

Distribution

Worldwide

Key facts

Status: Ongoing
Initiation date: 2025-09-10
Report date: 2025-10-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0109-2026