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 version 2.3 or higher.
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 that may have EEPROM chip errors when used with CARTO EP Navigation Systems. This could lead to incorrect cardiac mapping during procedures, potentially affecting patient safety.
The catheters may display incorrect error codes when used with CARTO EP Navigation Systems version 2.3 or higher, which could lead to improper cardiac mapping during electrophysiology procedures. This might result in ineffective treatment or unintended complications.
Healthcare providers using these catheters for cardiac electrophysiology procedures are most at risk. Patients undergoing such procedures with the recalled catheters could experience inaccurate mapping results.
Check for the serial numbers listed in the recall notice (e.g., 2451387, 2484264, etc.). The catheters are reprocessed BW Lasso 2515 NAV eco Variable Diagnostic EP Catheters with reference number D134301.
Verify if your catheters have any of the listed serial numbers (e.g., 2451387, 2484264, etc.).
The recall is due to potential EEPROM chip errors that may occur when these catheters are used with CARTO EP Navigation Systems version 2.3 or higher, which could lead to incorrect cardiac mapping.
Check if your catheters have any of the listed serial numbers. If they do, contact Stryker Sustainability Solutions for further instructions.
The recall indicates a potential risk of incorrect cardiac mapping during procedures, which could affect patient safety, but the exact risk level is not specified in the notice.
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-0916-2018 — Stryker Sustainability Solutions Stryker Sustainability Solutions Hello, I own a Stryker Sustainability Solutions that is covered by recall Z-0916-2018 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.
