Boston Scientific has issued a recall for the Chariot™ Guiding Sheath after receiving 14 reports of the device breaking, including some patients who required additional surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Chariot Guiding Sheath induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the Chariot Guiding Sheath?
The Chariot Guiding Sheath is inserted into a patient’s blood vessels. It is called a “guiding sheath” because it is used to help narrower tools slide inside the blood vessel. It is made by Boston Scientific Corporation and has been on the market since June 2015.
What is the problem?
November 19, 2015 — A voluntary Class I recall has been issued for about 7,000 Chariot Guiding Sheaths. Boston Scientific has received 14 reports of “shaft separation,” including four reports in which the shaft broke inside a patient’s body and had to be surgically removed. The problem has not been linked to any severe injuries or death, but life-threatening complications can occur. Additional surgery may also be necessary to retrieve the broken pieces.
Health Risks & Complications
- Shaft fracture or separation
- Embolization of fragments
- Obstruction of blood flow
- Additional surgery
- Stroke
- Kidney damage
- Intestinal damage
- Limb damage
- Death
Reports Describe Problems When Removing Chariot Guide
In several cases, shaft separation occurred when doctors were attempting to remove the Chariot from a patient. For example, in October the FDA received a report describing a sheath that “broke in half leaving half still inside the patient as they were pulling it out.”
Another report that month states: “While removing the sheath, the sheath broke near the top and remained inside the patient. … The surgeon then made a small incision and was able to fish out the remaining portion of the Chariot Guiding Sheath.”
FDA Recommendation
Doctors who used the Chariot Guiding Sheath should contact patients to check on their well-being. They may not have noticed shaft separation or embolized fragments during the procedure.
The FDA warns that the most severe complications occur when broken pieces of the Chariot sheath travel in a patient’s bloodstream (“embolize”) and cause circulation problems or organ damage:
“The most severe outcome of this failure is embolism of device fragments, which could lead to obstruction of blood flow or additional intervention to remove a device fragment. Obstruction of blood flow can result in injuries such as stroke, kidney damage or damage to the intestines or limbs.”
Do I have a Chariot Guiding Sheath Lawsuit?
The Schmidt Firm, PLLC is currently accepting Chariot Guiding Sheath induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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