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Terminated

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

FDA Recall Z-1512-06 · Posted 2006-09-23

Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeLOX
Date Initiated2006-07-21
Date Terminated2007-02-03
Product Quantity1,000

Reason for Recall

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

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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