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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Stryker Sustainability Solutions: BW Lasso 2515 NAV eco Catheters Recalled for Failure to Meet Testing Requirements

Agency Publication Date: July 3, 2024
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Summary

Stryker Sustainability Solutions is recalling 6 units of the BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter. These specialized medical devices, used for diagnostic electrophysiology (EP) procedures, were found to not meet necessary testing requirements. While only 6 units are affected by this specific event, they were distributed internationally to Japan and were manufactured in the United States. Consumers and healthcare providers should check their specific serial numbers to see if their device is part of this recall.

Risk

The catheters did not meet standard testing requirements, which could lead to device failure during a medical procedure. If a catheter fails while inside a patient's heart or vascular system, it could potentially cause internal injury or require additional invasive procedures to correct.

What You Should Do

  1. Identify if you have the Stryker Sustainability Solutions BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter (REF: D134301) by checking the serial number on the product packaging or device.
  2. Specifically look for the following Serial Numbers: 4175411, 4202651, 4116975, 4202652, 4175410, and 4175402. The UDI for these units is 00885825011680.
  3. If you are a healthcare provider or patient in possession of one of these specific serial numbers, contact your healthcare provider or Stryker Sustainability Solutions at 10232 S 51st St, Phoenix, Arizona, 85044-5205 for further instructions.
  4. For additional questions or to report any issues, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and coordination

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301
Model / REF:
D134301
UPC Codes:
00885825011680
Lot Numbers:
4175411
4202651
4116975
4202652
4175410
4175402

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94726
Status: Active
Manufacturer: Stryker Sustainability Solutions
Sold By: Medical facilities in Japan
Manufactured In: United States
Units Affected: 6 units

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.