LeMaitre Vascular, Inc. is recalling approximately 330,460 TufTex Over-the-Wire Embolectomy Catheters, Pruitt Occlusion Catheters, and Pruitt Irrigation Occlusion Catheters because the sterile packaging may have incomplete seals. This defect was discovered during internal product testing, and no injuries or incidents have been reported to date. These devices were distributed directly to hospitals and surgical centers nationwide and internationally.
If the sterile barrier of the package is incomplete, the catheter may become contaminated. Using a non-sterile device during a surgical procedure poses a risk of infection or other serious medical complications for the patient.
Includes all not-expired lots with the specified prefixes.
Includes all not-expired lots with the specified prefixes.
Includes all not-expired lots with the specified prefixes.
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.
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 · 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.