Medical devices manufacturer Boston Scientific has voluntarily recalled all models of its Fetch 2 Aspiration catheter due to complaints over shaft breakage.
Fetch 2 Aspiration catheter is a thrombectomy catheter used during procedures to remove small blood clots from coronary arteries.
The US Food and Drug Administration (FDA) classified the action as a Class 1 recall, which means that the use of the device exposes the patient to a reasonable chance of a serious adverse health consequence or death.
Under the recall, the company has advised affected healthcare facilities to discontinue use of all Fetch 2 catheters immediately and return unused product to the firm.
Boston Scientific purchased the Fetch 2 catheter product line from Bayer Medical Care, which were manufactured between 11 June 2014 and 19 February 2016.
Around 21,155 devices have been involved in the current FDA recall.
The company said that there have been no reports of patient injury or death, and there is no risk to patients who previously underwent a thrombectomy procedure with the Fetch 2 catheter.