Medtronic Infusion Pump Recall Status Raised to Class I Status
IV Pump News February 27, 2015
Medtronic PLC has announced that their recall of 1,248 infusion system units made last December has been raised to Class I status. Letters have been dispersed to alert each of the company’s customers.
The announcement was raised as a response to a manufacturing error involving mislabeled balloon inflation ports. The company has since warned that the recalled units put patients at risk of possible serious injury due to incorrect balloon deflation sequences. Arrangements are underway for the replacement of the recalled products, which were distributed in the U.S., Europe, Australia, Canada, and Turkey.
The voluntarily recalled devices, composing of several Trellis-6 and Trellis-8 infusion systems, are used to treat blood clots in the veins of arteries of the arms, hands, legs, or feet. The two balloons situated within the systems are inflated to isolate the clot. Medication is then released between the balloons to reduce the size of or dissolve the clot for removal. Should the balloons deflate in the incorrect order, there is a potential for blood clots to dislodge and move into the lungs.
According to the company, the infusion pumps were manufactured and distributed between January and November of 2013 by Medtronic's newly acquired company, Covidien PLC. Medtronic has reassured its customers that patients who have been treated with the recalled devices require no immediate action but encourage physicians to continue monitoring patients under established standards of care.
Class I FDA recalls are the most serious type of recall and signify the probability that using these products could cause serious health consequences or death, as stated by the Food and Drug Administration website.
Clinicians should ensure that their medical equipment is well-maintained and up-to-date to ensure patient safety. AIV is committed to providing medical-grade refurbished IV pumps, replacement parts, accessories and repair services for most leading manufacturers. Browse through AIV’s full line of infusion pump solutions by visiting http://aiv-inc.com/iv-pump-parts-service.html