Labeling mix-up leads to serious recall of Covidien's (now Medtronic's) infusion system

Trellis 6--Courtesy of Covidien

More than 1,000 of Medtronic's ($MDT) Trellis Peripheral Infusion Systems have misidentified balloon ports on the device itself, which could result in fatal errors, leading the FDA to issue its most serious type of recall on both models of the product.

The agency yesterday posted two Class I recalls on its website, for the Trellis 6 (containing a catheter with a 6 French, or 2 millimeter, diameter) and the Trellis 8 (containing a catheter with an 8 French, or 2.66 millimeter, diameter). The FDA defines a Class I recall as one in which "there is a reasonable probability that use of these products will cause serious adverse health consequences or death."

The problem with Trellis is exceedingly simple. The device contains two balloons, one located closer to the body (distal) and another on the far away (or proximal) tip of the catheter. But the labeling on the device identifies the distal balloon port as the proximal one, and the proximal port as the distal one.

The FDA says 216 Trellis 6 systems have been recalled, including 9 outside the U.S., as well as 1,032 Trellis 8 systems, including 113 outside the U.S.

Covidien, which was just acquired by Medtronic for almost $50 billion, says that the device is intended for "controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature." Thrombolytic medications are used to dissolve blood clots in the case of heart attack, stroke or another disease involving blocked blood vessels, such as peripheral artery disease, which afflicts the peripheral vasculature.

A close up of the proximal and distal balloons that are at the center of the recall--Courtesy of Covidien

Among the product features listed on the Trellis website are "two latex-free compliant balloons to assist with isolation of clot and thrombolytic agent." Unfortunately, the company seems to have misidentified one balloon as the other, leading to the recall.

The recall notice contains the affected model and lot numbers. It says that customers were sent a recall letter in December 2014 and told to return the device to Covidien.

The FDA's adverse event database shows that continuous flush catheters made by various companies have been the subject of several customer complaints, including 82 reports of breakages, 58 reports of an obstruction within the device and 56 reports of balloon leakage.

- here's the recall notice for the Trellis 6 | for the Trellis 8
- more information about safety issues associated with continuous flush catheters

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