Recall Z-2138-2013 · LIT Catheter, Angioplasty, Peripheral, Transluminal

Boston Scientific Corporation

Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting BalloonTM MonorailTM Microsurgical Dilatation Device, UPN #H749CBM3400150 Catalogue # CBM340015 & UPN# H749RB4400150 Catalogue # RB440015 2) 4.00mm x 15mm FlextomeTM Cutting BalloonTM Over-the-Wire Microsurgical Dilatation Device, UPN # H749CBO3400150, Catalogue # CBO340015 The

Date	Sep 3, 2013 (initiated Jul 31, 2013)
Status	Terminated
Reason	Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilatation Devices and Flextome Cutting Balloon (Monorail and Over-the-Wire) Microsurgical Dilation Devices. Boston Scientific has determined that users may experience significant difficulty or inability to remove the protector cap from the devic
Root cause	Process change control
Action	Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 30, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised that further distribution or use of the product should cease immediately, and to segregate the product and return it to Boston Scientific. Consignees were asked to complete and return the "Recall Removal Reply Verification Tracking Form". For questions consignees were instructed to contact their local Sales Representative. For questions regarding this recall
Quantity	340
Distribution	Worldwide Distribution - USA including AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV,NH,NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC,SC, TN, TX, UT, VA, WA, WV, and WI. Internationally to Algeria, Finland, Japan, Spain, Australia, France, Latvia, Swed
FDA record	Open on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.