The Ministry of Health and Community Protection has warned of the LeMaitre Over the Wire Embolectomy Cathete, which is used to surgically remove blood clots, because of the possibility of a technical defect that may cause permanent disability for the patient.
This came in a circular addressed by the Ministry to all health facilities and health care practitioners in the private sector, where the Ministry recommended the necessity of withdrawing the aforementioned medical facility, and preventing its circulation and import.
The ministry pointed out that the warning came after the US Food and Drug Administration issued a warning to withdraw the aforementioned medical device, in view of the possibility of difficulty in ballooning after placing it, which may lead to fragmentation and separation when trying to extract it, and this may result in serious health consequences represented in heart damage The blood vessels, as additional measures must be taken to collect the fragments resulting from the balloon fragmentation, which may cause permanent disability in the patient, damage to other body parts, or lead to death.
The Ministry stated that it was found that the aforementioned medical means was available to distributors inside the country, knowing that it was not registered in the Ministry's drug administration.