Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiation: 1) 4.00mm x 15mm FlextomeTM Cutting Ballo

FDA device recall Z-2138-2013 · posted 2013-09-03 · Terminated

Recall details

Recalling firm

Boston Scientific Corporation

Reason for recall

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

Action taken

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 call 763-494-2042.

Root cause

Process change control

Status

Terminated

Product code

LIT

Quantity affected

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,

Date initiated

2013-07-31

Date posted

2013-09-03

Date terminated

2015-01-27

Location

Maple Grove, MN