Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 017

FDA device recall Z-1512-06 · posted 2006-09-23 · Terminated

Recall details

Recalling firm

Boston Scientific

Reason for recall

Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)

Action taken

On July 21, 2006, Boston Scientific initiated a voluntary recall of 45 lots/batches of Cutting Balloon Ultra Monorail Devices due to their determination that the lots do not meet their sterilization requirements. There is a remote possibility of infection in the patient. An infection, if it occurred, could be recognized and treated effectively in these patients. Boston Scientific is not aware of any complaints related to this product issue. Letters dated July 21, 2006, were sent to their customers with instructions to cease further distribution, complete and return a tracking form, and product return instructions.

Root cause

Other

Status

Terminated

Product code

LOX

Quantity affected

1,000

Distribution

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, P

Date initiated

2006-07-21

Date posted

2006-09-23

Date terminated

2007-02-03

Location

Maple Grove, MN