# FDA recall Z-2541-2020

> **Abbott** · Class II · device recall initiated 2020-05-22.

## Product

TactiCath Quartz Contact Force Ablation Catheter, Model Numbers:  PN-004 065 (GTIN 07640157990033) and PN-004 075 (GTIN 07640157990040) - Product Usage: is a multi-electrode irrigated catheter with a deflectable tip designed to allow electrophysiological mapping of the heart and, when connected to an RF generator, to deliver radiofrequency current to the catheter tip electrode for the purpose of ablation.

## Reason for recall

High rate of reported complaints for the loss of contact force information while using the TactiCath Quartz Contact Force Ablation Catheter

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2541-2020
- **Recalling firm:** Abbott
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-22
- **Report date:** 2020-07-15
- **Termination date:** 2021-02-11

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plymouth, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2541-2020

## Citation

> AI Analytics. FDA recall Z-2541-2020. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2541-2020. Source: US FDA. Licensed CC0.

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