Device Recall Ultra2 Cutting Balloon

Material Number (UPN) / Catalog Number / Lot/Batch #:  H749CBM200060 / CBM20006 / EG0438 & EG0499;  H749CBM200100 / CBM20010 / EG0427;  H749CBM225060 / CBM22506 / EG0448 & EG0471;  H749CBM225100 / CBM22510 / EG0444 & EG0502;  H749CBM250060 / CBM25006 / EG0439 & EG0472;  H749CBM250100 / CBM25010 / EGO425, EG0440, EG0474 & EG0475;  H749CBM250150 / CBM25015 / EG0466;  H749CBM275060 / CBM27506 / EG0420 & EG0487;  H749CBM275100 / CBM27510 / EG0419 & EG0456;  H749CBM275150 / CBM27515 / EG0424;  H749CBM300060 / CBM30006 / EG0423, EG0473 & EG0497;  H749CBM300100 / CBM30010 / EG0426, EG0441, EG0465, EG0485;  H749CBM300150 / CBM30015 /EG0443 & EG0418;  H749CBM325060 / CBM32506 / EG0500;  H749CBM325100 / CBM32510 / EG0422 & EG0501;  H749CBM325150 / CBM32515 / EG0467;  H749CBM350060 / CBM35006 / EG0437;  H749CBM350100 / CBM35010 / EG0349, EG0428, EG0468;  H749CBM350150 / CBM35015 / EG0421 & EG0486;  H749CBM375060 / CBM37506 / EG0503;  H749CBM375100 / CBM37510 / EG0457;  H749CBM375150 / CBM37515 / EG0455;  H749CBM400060 / CBM40006 / EG0504;  H749CBM400100 / CBM40010 / EG0442 & EG0498;  H749CBM400150 / CBM40015 / EG0476.

Cardiovascular Devices

2

No

Class II Recall - Nationwide distribution ---- including states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV, and WY.

Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.