The New Medtronic Inherits a Class I Covidien Recall

Medtronic may be getting strategic benefits from its recently closed merger with Covidien, but it also has extra Class I recalls to handle.

Nancy Crotti

FDA has issued a Class I designation over a Medtronic recall of two of the company's blood clot removal devices over labels that the agency said could confuse physicians and kill patients.

The recall involves the Trellis 6 and Trellis 8 peripheral infusion systems. The systems--made by what was Covidien before Medtronic closed on its $48 billion acquisition last month--have two balloons that are inflated to isolate a clot in an arm, leg, hand, or foot. Medication is released between the balloons to shrink or dissolve the clot so it can be removed.

FDA blamed a "manufacturing error" for the mislabeling of the ports. If the balloons are inflated in the incorrect order, "there is a potential for blood clots to dislodge and move into the lungs," the agency said in a statement. "Depending upon the size of these clots, there is the possibility of serious patient injury or death."

Covidien (now part of Medtronic plc, headquartered in Dublin, Ireland), distributed 1126 of the units in the U.S. from June 6, 2014 to November 13, 2014.

This is the second Class I recall for Covidien products in the past six months in which none of the products involved was defective. Rather, the danger came from the possibility of misuse by health professionals unaware of the potential for endangering patients.

In October 2014, Covidien voluntarily recalled more than 600,000 Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators. Health providers and other users were apparently unaware that the Covidien electrodes donot connect with Philips FR3 or FRx AED units and connected them anyway, contributing to a delay in resuscitation and possibly to the subsequent death of one patient, Covidien said at the time.The equipment manual specified that Philips brand electrodes were to be used.

Ventilators have also been an issue for Covidien. Covidien described its new Puritan Bennett 980 ventilator as "simple, safe, and smart" when it won regulatory approval in the U.S. and Europe in early 2014. But a year later, it is now been the subject of two Class I-level recalls related to circuit board and potential software issues.

Nancy Crotti is a contributor to Qmed and MPMN.

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