Boston Scientific is recalling its medical device, a hemostasis valve-attached catheterizer, in Korea.

According to the Ministry of Food and Drug Safety, Boston Scientific Korea submitted a recall plan for the hemostasis valve-attached catheterizer on Feb. 19 and began recalling the device.

Sixty-two units of the item were produced (imported) domestically, and 34 units were recalled, excluding 28 units in stock. The recall is currently underway.

The recall follows an internal investigation that found a manufacturing defect in hemostasis valves with a specific manufacturing number. This defect may result in higher-than-expected blood loss during procedures.

The degree of harm in this recall falls under Article 52, Paragraph 2, Item 3 of the Enforcement Rules of the Medical Device Act, meaning that using the medical device rarely causes adverse effects. Still, there is a problem with safety and effectiveness due to non-compliance with the standards under Article 19 of the Medical Device Act.

With the submission of the recall plan, Boston Scientific Korea reported that no additional risks have been identified for patients who received the procedure using the product.

Boston Scientific Korea requested healthcare organizations and distributors to "check the shipment history included in the notice and, if you have the product in stock, immediately separate it and return it to us."

"Even if you do not have the product in stock, please confirm the recall and sign and return the Medical Device Recall Confirmation Form," the company said.

"We will immediately request medical institutions to stop using the product and recall the remaining quantity in stock," Boston Scientific Korea said. “We will notify all medical institutions of the recall even if the product is not in stock."