Medtronic leads in FDA Class I recalls for 2013

Medtronic ($MDT) generated more Class I recalls than any of its device company rivals in 2013. The FDA assigns that status--its most serious label--when problems behind a product can cause serious injury or death.

Medical Device and Diagnostic Industry compiled FDA data and found that Minnesota-based Medtronic generated 6 Class I recalls during the year. The recalls involved issues with a wide range of products, including guidewires, endotracheal tubes, dystonia therapy and deep brain stimulation lead kits, infusion pumps and insulin infusion sets.

Johnson & Johnson ($JNJ), GE Healthcare ($GE), CareFusion ($CFN) and Hospira ($HSP) rounded out the top 5, according to the story.

FierceMedicalDevices could not successfully reach Medtronic for comment prior to publication.

As Medical Device and Diagnostic Industry reported, Johnson & Johnson and GE Healthcare both landed on the list with 5 Class I recalls, tying for second place. J&J was dogged by problems with insulin infusion pumps, vena cava filters, a blood glucose monitoring system and other products. GE dealt with Class I recalls involving nuclear imaging systems, devices that help enable ventilation, resuscitation systems, parts for a breathing system and an incubator.

San Diego-based CareFusion and Hospira tied for third place with four Class I recalls each. CareFusion faced a recall involving a ventilator and three for a PC unit, and Illinois-based Hospira dealt with three separate recalls for a key infusion system. Separately, Hospira also confronted a recall involving some of its blood sets, which are used to administer blood and blood products to patients.

Overall, the FDA handled 176 Class I recalls in 2013, the story noted.

- read the full MD+DI story

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