Recalls

Coviden recalls blood clot infusion system due to manufacturing error

blood cells Coviden recalls blood clot infusion system due to manufacturing errorCoviden’s Trellis 6 and 8 peripheral infusion systems used to treat blood clots that form in the veins or arteries of the arms, hands, legs or feet, are being recalled. A manufacturing error may cause blood clots to dislodge and move to the lungs, where they can be fatal.

The error caused the balloon inflation ports to be mislabeled, and this may cause the physician using the device to deflate the balloons in the incorrect order. Depending on the size of the blood clot being treated, there is the possibility of serious patient injury or death, qualifying the recall as a Class I, the most serious type classified by the Food and Drug Administration (FDA).

The Trellis 6 and Trellis 8 Peripheral Infusion systems have two balloons that are inflated to isolate a blood clot. Medication is released between the balloons to reduce the size of or dissolve the clot so it can be removed.

Medical facilities that received the devices were sent an urgent product recall letter informing them of this error, and instructing them not to use the devices and to return them to Coviden.

Any adverse events associated with these recalled products should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA