FDA Classifies Field Action for the Trellis-6 and Trellis-8 Peripheral Infusion Systems as a Class 1 Recall

February 12, 2015—Medtronic plc announced that a previously communicated global voluntary recall to address an issue with certain lots of its Trellis-6 and Trellis-8 peripheral infusion systems has now been classified as a Class 1 recall by the US Food and Drug Administration. Customers were previously notified by Covidien of the recall on December 15, 2014. Covidien merged with Medtronic, Inc. on January 26. The company has not received any reports of patient injuries related to this issue.

The company advised that if a patient has received treatment with a Trellis 6 or Trellis 8 from the impacted lots, no immediate action is required and physicians should continue to monitor patients in accordance with standard of care.

The Trellis-6 and Trellis-8 (Athena) peripheral infusion systems are indicated for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

According to Medtronic, this action was in response to a manufacturing error where the proximal and distal balloon inflation ports were labeled incorrectly, resulting in the potential for incorrect sequence of balloon deflation. If the physician using the device were to mistakenly deflate the balloons out of order, there is a potential for blood clots to travel downstream and become lodged in the lungs. Depending upon the size and location of these clots, there is the possibility of serious patient injury. Covidien learned of this issue through customer reports identifying incorrect balloon port identification.

The recall involves 1,248 units manufactured and distributed by Covidien from January 2014 to November 2014. The recall includes the Trellis 6 (models BVT608010V01, BVT608030V01, BVT612010V01, and BVT612030V01) and Trellis 8 (models CVT808015V01, CVT808025V01, CVT812015V01, CVT812025V01, EVT808015V01, EVT808025V01, EVT812015V01, and EVT812025V01).

Medtronic has alerted customers of the recall by letter and is arranging for replacement of the recalled products. The products were distributed in the United States, Europe, Australia, Canada, and Turkey. The FDA and other regulatory bodies have been notified. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program. The company will continue to work closely with customers and global regulatory authorities to resolve this issue, stated Medtronic.