Generic Name: Carotid Stent — Brand Name: Carotid Wall Stent Monorail

Carotid Wall Stent Monorail Recall Summary Boston Scientific is recalling specific lots of Carotid Wall Stent Monorail devices used to keep narrowed carotid arteries open because the guidewire opening in some units was manufactured smaller than specifications. This manufacturing defect can cause resistance when removing the delivery system after stent placement, potentially requiring doctors to reinsert the guidewire and extend procedure time. The recall affects 1,847 devices distributed between December 2024 and July 2025 across multiple lot numbers.

Recalling firm

Name of Manufacturer and Distributor: Boston Scientific Japan K.K. — Address of Manufacturer and Distributor: Nakano Central Park South, 4-10-2 Nakano, Nakano-ku, Tokyo — Type of License: Class I...

Product

Lot: 品番：H7493915010240 対象ロット： 35277608 35315983 35315984 35315985 35380314 35452835 35452836 35514614 35551688 35551689 35664523 35664524 35750157 35750158 35750159 35750400 35879409 35879410 35921915 35922951 35926817 35926818 35942366 36056965 36058841 36058843 36096638 36138618 36138619 36138801 36138803 36159671 36195057 36205167 36214805 36348209 品番：H7493915010310 対象ロット： 35294379 35294540 35295922 35330503 35330504 35336132 35347263 35382292 35383351 35383352 35453002 35461487 35461488 35528579 35529200 35628964 35628965 35628966 35641995 35664484 35664485 35750401 35750402 35750403...

Reason

Following an increase in reports that, when removing the delivery system after stent deployment of certain lots of the “Carotid Wall Stent Monorail” (hereinafter referred to as “this product”), users encountered significant resistance from the guidewire or distal embolization prevention device (EPD) used in conjunction with the stent (hereinafter referred to as “this incident”). As a result of our investigation, we confirmed that in certain lots of this product, the dimensions of the guidewire lumen fell below the specified standards due to settings in the equipment used in the...

Classification

Class I

Category

medical device recall

Country

Japan

Agency

PMDA-DEVICE

Status

Ongoing

Official recall notice from PMDA-DEVICE

Recall details on Nibble Recalls: https://trynibble.app/recalls/235e10d6-23de-4f34-9637-108e026d6d14