Devices & Diagnostics

Medtronic’s Monday: FDA device warning, release of new bone graft system

Medtronic (NYSE:MDT) on Monday dealt with the U.S. Food and Drug Administration recall of a battery problem in one of its drug delivery pumps. On the same day, it announced a new set of screws and products for bone grafts and other kinds of cosmetic dentistry. The FDA announced a Class I recall of the […]

Medtronic (NYSE:MDT) on Monday dealt with the U.S. Food and Drug Administration recall of a battery problem in one of its drug delivery pumps. On the same day, it announced a new set of screws and products for bone grafts and other kinds of cosmetic dentistry.

The FDA announced a Class I recall of the SynchroMed II, which delivers drugs into the spine, for a faulty battery. More than 139,000 SynchroMed II pumps are implanted worldwide and there has been one death reported. Medtronic started shipping an improved battery in July. Minnesota’s Star Tribune cited a Morningstar analyst who said she didn’t expect the recall to hurt Medtronic.

Meanwhile, the company rolled out a new product in its spinal division. The ARTISAN system for oral surgery includes a series of screws for the facial bones to help with a series of oral procedures – in particular, bone grafts. Medtronic cited statistics that indicate there will be 1.4 million bone graft cases. Medtronic says its system is easier for surgeons to use and provides better support to protect an bone graft.