Stryker recalls reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters due to potential EEPROM chip errors when used with CARTO EP Navigation Systems. Affected units have specific serial numbers.
An EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems.
Stryker is recalling reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters because they may cause EEPROM chip errors when used with CARTO EP Navigation Systems. This could lead to inaccurate cardiac mapping during procedures.
The catheters may develop an EEPROM chip error code when used with CARTO EP Navigation Systems version 2.3 or higher. This error could cause inaccurate cardiac mapping during electrophysiology procedures, potentially leading to incorrect treatment decisions.
Healthcare professionals using these catheters for cardiac electrophysiology procedures are most at risk. Patients undergoing such procedures with affected catheters may experience inaccurate mapping.
Check for serial numbers listed: 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528. The catheters are reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters with reference number D134302.
Verify if your catheters have any of the listed serial numbers: 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, or 2500528.
The record states an EEPROM chip error code may occur when the catheters are used with CARTO EP Navigation Systems, but does not specify the exact error.
Check for the listed serial numbers: 2468846, 2468849, 2509029, 2489074, 2491174, 2500529, 2465989, and 2500528.
The recall does not specify a remedy or immediate action, so there is no instruction to stop using them now.
We’ve drafted a message you can send Stryker Sustainability Solutions to request your refund or repair — edit it as you like.
Subject: Recall Z-0917-2018 — Stryker Sustainability Solutions Stryker Sustainability Solutions Hello, I own a Stryker Sustainability Solutions that is covered by recall Z-0917-2018 from Stryker Sustainability Solutions. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
