Serious Complications with Guiding Sheath Leads to Class I Recall
According to MassDevice, Boston Scientific released a statement yesterday regarding their voluntary recall of Chariot Guiding Sheaths used during vascular procedures due to hazards involving potential shaft separation.
FDA Designates Recall Class 1
This recall comes as an FDA labeled Class I, the most serious level of recall, as there is high probability malfunction of the item can cause death or serious health consequences.
Boston Scientific had warned doctors were warned of potential issues in October after having received three reports that guide wire broke off during use. Moreover, on October 12, the company contact the FDA about a particular incident after the sheath was used on a patients leg artery, saying:
“At the end of the procedure, as the physician was coming out, the chariot sheath broke in half leaving half still inside the patient as they were pulling it out. They went ahead and kept pulling the inner wiring of the sheath. When the rest of the device became visible, they grabbed a hemostat to pull the remaining portion of the sheath out of the patient. No patient complications were reported and the patient’s status is fine.”
Potential Harm to Patients
- Boston Scientific reported 14 complaints of shaft separation, four of which occurred during device preparation or use.
- According to a company release, after separation there is risk of embolism of device fragments which could obstruct blood flow and require intervention.
- Furthermore, the obstruction of blood flow could potentially lead to “stroke, kidney damage, or damage to the intestines or limbs.”
- Doctors with patients who have had procedures with the devices have been urged to contact them and be vigilant to potential malfunctions.