The Minnesota-based Teleflex Inc., on Thursday, June 22, 2017, issued a voluntary recall of what's estimated to be around 4,000 surgical catheters. The recall, which has been classified as the most critical, Class 1 variety, covers any catheters manufactured by Teleflex's subsidiary Vascular Solutions.
The catheters that have been recalled in this case are generally implanted into a patient's blood vessels to avoid doctors having to complete more 'open' types of surgeries. In lining a patient's blood vessel with this thin tube, it allows patients to take advantage of minimally invasive procedures.
These catheters are also used to transport microscopic surgical tools to a patient's heart and lungs. They may also help the surgeon more easily saturate certain areas of the body with either a type of contrast dye or saline necessary to render proper diagnoses. As for this most recent announcement from this defective medical product's manufacturer, there is a sense of urgency to the recall.
They had initially recalled 4,679 units they had sold under the name of Venture catheters back in April of 2017. At that time, it had come to their attention that the medical device was manufactured using additional material that seemed to break free from it when doctors performed their medical procedures. This was believed to present an embolism risk.
The most recent press release reiterated that there have been no known reported cases of patients suffering any harm. However, in consulting with the Food and Drug Administration, both parties agreed that the product's recall should be upgraded to a first class one. With Class 1 recalls, there is a reasonable degree of fear that the device may result in either serious injury or death.
Hospitals with unused catheters have been urged to return their supply of the product to the manufacturer. If you think you might have had this catheter used during a treatment or procedure you underwent, then you may want to contact a Tucson, Arizona defective medical device attorney to discuss potential remedies in your case.
Source: Star Tribune, "Recall of Vascular Solutions catheters is declared Class 1," Joe Carlson, accessed July 21, 2017