Boston Scientific Recalls Chariot Guiding Sheath Over Risk Of Shaft Separation

Boston Scientific has voluntarily recalled its Chariot guiding sheath, due to a risk of shaft separation.

Roughly 5,700 units were recalled from the field starting Nov. 19, 2015, the company announced in early December. The devices were manufactured from March 17 to Nov. 10, 2015, and distributed from June 6, to Nov. 17, 2015. The FDA classified the action as a Class 1 recall.

The device helps introduce interventional devices during peripheral vascular procedures.

The company said it has received 14 complaints for shaft separation, four of which involved separation of the distal shaft. The 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.

“An investigation is currently being conducted by Boston Scientific to determine the cause,” company spokesman Tom Keppeler said.

No permanent injuries or patient deaths have been reported, according to the company.

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