FDA Medical Device Recalls (openFDA)
Boston Scientific: Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
- Recall number
- Z-1512-06
- Recalling firm
- Boston Scientific
- Product
- Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
- Status
- Terminated
- Initiated
- 2006-07-21
- Posted
- 2006-09-23
- Terminated
- 2007-02-03
- Reason
- Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- ["P950020"]
- Product code
- LOX
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28