Boston Scientific has voluntarily recalled its Chariot Guiding Sheath after just six months on the market. The FDA received 21 reports of injuries caused by the device during that period. It received the first complaint six days after the Chariot Guiding Sheath became available.
The Chariot Guiding Sheath’s removal from the market has been labeled a Class 1 recall, the FDA’s category for extremely dangerous medical devices that can cause serious injury and even death.
The Chariot Guiding Sheath is a long, thin, hollow tube (catheter) that doctors insert into a blood vessel to guide even thinner instruments through a vein to treat blockages or diagnose other conditions.
Fragments of the Chariot Guiding Sheath have been breaking off inside patients’ bodies. The fragments can cause embolisms (traveling blood clots) that block the blood flow to vital organs, causing strokes and/or damage to the kidneys, intestines and limbs. Boston Scientific voluntarily recalled the device in mid-November. It went on the market in early June.
Boston Scientific is a $16.9 billion medical corporation, based in Massachusetts that specializes in products and technologies used to treat a variety of medical conditions that affect the heart, the urinary tract, the lungs and vascular system and chronic pain. It was founded in 1979 and has become a global entity with its European headquarters in Paris, France and ongoing interests in India and China.
According to the FDA, doctors have not always realized it when pieces of the device broke off in a patient’s veins. The federal agency is asking all physicians to contact patients they have treated with the Chariot Guiding Sheath and to cease using it immediately. They are also being asked to return the device to its manufacturer, Boston Scientific. So far, no deaths have been reported. But patients who were treated with the device could still be at risk.
For more than 30 years, Wayne Wright has been representing victims of faulty medical devices and bad drugs. Wayne Wright has been voted one of the Top 100 Trial lawyers in the U. S. In the last seven years alone, his legal expertise has earned more than $237 million for clients across the United States.
Those who place their trust in Wayne Wright can be assured they will enjoy prompt attention, frequent updates and notifications of court rulings and responses as their case progresses. Consultations are free. You only pay if the firm wins your case. The amount depends on a percentage agreed upon in advance. If you or a loved one suffered an injury caused by a Chariot Guiding Sheath, you can depend on Wayne Wright’s legal expertise for knowledgeable, compassionate assistance.