Z-1512-06

Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place...

Name: Z-1512-06 Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place...
Creator: Boston Scientific
Published: 2006-07-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2006-07-21 / Terminated / root cause: sterility

FDA source

Boston Scientific began a recall of Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760 on 2006-07-21. The reason FDA records is "Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1512-06
Status: Terminated
Initiated: 2006-07-21
Posted: 2006-09-23
Terminated: 2007-02-03
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
Product code: LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Reason for recall: Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
Root cause tag: sterility
FDA root cause: Other
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.
Quantity in commerce: 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, PA, SC, TN, TX, VA, VT, WA, WI, WV, and WY.
Product codes and lots: 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.

Product code LOX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)