# FDA recall Z-0916-2018

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2018-01-02.

## Product

Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134301, Sterile, Rx.      The Reprocessed 2515 NAV eco Variable Electrophysiology (EP) Catheters are indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation only. They are designed to obtain electrograms in the atrial regions of the heart. The Reprocessed 2515 NAV eco Variable EP Catheters provide location information when used with compatible CARTO EP Navigation Systems version 2.3 or higher.

## Reason for recall

An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.

## Distribution

USA (nationwide) Distribution was made to medical facilities in AZ, CA, CT, FL, GA, IL, KS, LA, MN, MO, OH, PA, TX, VT, WA, and Wi.   Foreign distribution was made to Canada.

## Key facts

- **Recall number:** Z-0916-2018
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-01-02
- **Report date:** 2018-03-14
- **Termination date:** 2018-05-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0916-2018

## Citation

> AI Analytics. FDA recall Z-0916-2018. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0916-2018. Source: US FDA. Licensed CC0.

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