FDA classifies Covidien field action for Trellis-6 and Trellis-8 systems as a Class 1 recall

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Medtronic announced today 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 (FDA).

Customers were previously notified by Covidien of the recall in December 2014. The company has not received any reports of patient injuries related to this issue. Medtronic’s announcement says 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 FDA action was in response to a manufacturing error where the proximal and distal balloon inflation ports were labelled 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.

The recall involves 1,248 units manufactured and distributed by Covidien from January 2014 to November 2014. Covidien learned of this issue through customer reports identifying incorrect balloon port identification.

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.

The recall includes the following models:

Model Description
BVT608010V01 Trellis 6
BVT608030V01 Trellis 6
BVT612010V01 Trellis 6
BVT612030V01 Trellis 6
CVT808015V01 Trellis 8
CVT808025V01 Trellis 8
CVT812015V01 Trellis 8
CVT812025V01 Trellis 8
EVT808015V01 Trellis 8
EVT808025V01 Trellis 8
EVT812015V01 Trellis 8
EVT812025V01 Trellis 8