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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/Surgical Equipment

Stryker Neurovascular: Distal Access Catheter Recalled for Potential Endotoxin Contamination

Agency Publication Date: May 1, 2024
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Summary

Stryker Neurovascular is recalling 43 units of its DAC Distal Access Catheter -038 136cm because they were released with endotoxin levels that exceeded safety specifications. This specialized medical device is a braided catheter used in neurovascular procedures to provide access to blood vessels. Affected units were distributed to healthcare facilities in 12 states between April and May 2024. Consumers and healthcare providers should check their inventory for Lot #0000486382.

Risk

The presence of out-of-specification endotoxins can cause a serious inflammatory response or systemic infection (sepsis) when the device is used in the bloodstream. This poses a significant risk to patients undergoing neurovascular procedures, where sterility is critical.

What You Should Do

  1. Immediately check your medical inventory for the DAC Distal Access Catheter -038 136cm with Lot Number 0000486382 and UDI-DI 07613327313895.
  2. Verify if the device has an expiration date of July 17, 2025 (17-Jul-2025).
  3. If you identify any affected catheters, stop using them immediately and quarantine the product to prevent accidental use.
  4. Contact your healthcare provider or Stryker Neurovascular at their Fremont, California facility for specific instructions regarding the return of the affected lot and to discuss potential patient impacts.
  5. For additional information or to report concerns, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Removal of affected product from inventory

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

Affected Products

Product: DAC - Distal Access Catheter -038 136cm
Model / REF:
Z-1740-2024
UPC Codes:
07613327313895
Lot Numbers:
0000486382
Date Ranges: Expiration: 17-Jul-2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94347
Status: Active
Manufacturer: Stryker Neurovascular
Sold By: Authorized Medical Distributors; Hospitals
Manufactured In: United States
Units Affected: 43
Distributed To: Texas, Florida, New Jersey, Colorado, Louisiana, North Carolina, Alabama, Pennsylvania, Michigan, Mississippi, South Carolina, Illinois

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.