Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco… — Class II medical device recall Z-0916-2018
Terminated recall by Stryker Sustainability Solutions, reported 2018-03-14, distributed nationwide. An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
| Recall number | Z-0916-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2018-01-02 |
| Classified | 2018-03-06 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-05-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 170 devices |
| Serial numbers | 2451387, 2484264, 2484471, 2486823, 2487380, 2488350, 2490592, 2490605, 2492930, 2494064, 2494067, 2495242, 2495335, 2495337, 2495339, 2500403, 2500911, 2510524, 2518512, 2523848, 2523849, 2523851, 2525678, 2528071, 2534854 and 145 more |
| Model numbers | D134301 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0916-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.