Late last month, the U.S. Food and Drug Administration issued an additional
warning about an artery cleaning tool made by prominent medical device
manufacturer Boston Scientific Corp. The device has now been linked to
several injuries and one death.
Boston Globe reports, the devices are called the RotaWire Elite Guidewire and wireClip Torquer
Guidewire and were both used to help widen arteries and clean plaque from
artery walls. It is now believed that wires can break off from these devices,
endangering patients. Following a voluntary recall in October from Boston
Scientific, the FDA again warned the public that use of the devices "may
cause serious adverse health consequences, including death."
Tom Keppeler, Boston Scientific's spokesman, told the paper that the
company had voluntarily recalled the devices "due to the possibility
of wire fracture." He also said that the 30 U.S. hospitals who were
using the devices have been notified of the dangers associated with their use.
Dangerous Heart Stents, IVC Filters, & Other Cardiovascular Devices
Fortunately for patients, the RotaWire Elite Guidewire and wireClip Torquer
Guidewire were not widely distributed when its defects were discovered--
there are only about 600 of them on the U.S. market. However, they represent
the latest in a growing trend of dangerous cardiovascular devices have
been put out on the market.
IVC filters are perhaps the most well-known of these devices: a spider-like
metal device inserted in an artery to help catch dangerous clots from
circulating around the body. Many of these filters proved to be dangerous—even
deadly—when it was found that the metal wiring was prone to break
apart, sending dangerous shrapnel through a patient's circulatory
system. Lawsuits from all over the country have been filed against C.R.
Bard and Cook Medical for the manufacturing of these harmful filters.—when
it was found that the metal wiring was prone to break apart, sending dangerous
shrapnel through a patient's circulatory system. Lawsuits from all
over the country have been filed against C.R. Bard and Cook Medical for
the manufacturing of these harmful filters.
If you have been hurt by a dangerous cardiovascular device, then it is
time to start exploring your legal options. At
The Law Offices of Patrick L. Block, P.C., Attorney Block is well-versed in the effort and diligence necessary to
hold medical device manufacturers accountable for their mistakes. Our
firm has recovered millions of dollars on behalf of clients who have been
harmed by the health industry and knows that it takes to produce results
for the individuals and families that count on us.
You do not have to let this breach of trust stand. Contact us today to
free case evaluation.