FDA Device recall Z-0917-2018
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reproces…
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, Sterile, Rx. The Reproces… by Stryker Sustainability Solutions, citing an EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0917-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-02 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | US |
Product
Stryker Sustainability Solutions Reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters, Ref D134302, 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
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Identifiers
| code_info | Serial numbers 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0917-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.