The devices are intended for the introduction of interventional devices during peripheral vascular procedures, and were recalled on 19 November due to the risk of shaft separation. The US Food and Drug Administration (FDA) has classified the action as a Class-1 recall.
To date, Boston Scientific has received fourteen complaints for shaft separation, four of which involved separation of the distal shaft. These events occurred during device preparation or use. 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. To date, no permanent injuries or patient deaths have been reported.
All affected healthcare facilities were previously advised to immediately discontinue use of affected devices and return unused Chariot sheaths to Boston Scientific. Additionally, physicians are encouraged to contact all patients who have undergone procedures involving Chariot to confirm their post-procedure status, as device shaft separation and embolised fragments may not have been recognised at the time of the procedure.
The recall affects all Chariot guiding sheaths. Customers have been advised to remove the affected recalled product from inventory and return it to Boston Scientific.
Physicians and healthcare facilities can direct questions to their Boston Scientific. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA MedWatch Adverse Event Reporting programme either online, by post or by fax.