# FDA recall Z-0957-2022

> **Abbott** · Class II · device recall initiated 2022-03-24.

## Product

Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.

## Reason for recall

Devices were manufactured with a "First Use Date" preprogrammed in the EEPROM which disables the use of the single-use device.

## Distribution

Worldwide distribution - US Nationwide - there was government distribution but no military. The countries of Austria, Belgium, Canada, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Palestine, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Taiwan, and United Kingdom.

## Key facts

- **Recall number:** Z-0957-2022
- **Recalling firm:** Abbott
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-24
- **Report date:** 2022-04-27

- **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-0957-2022

## Citation

> AI Analytics. FDA recall Z-0957-2022. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0957-2022. Source: US FDA. Licensed CC0.

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