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Boston Scientific Cutting Balloon Ultra2 Monorail Device… recallZ-1512-06 · Boston Scientific · initiated Jul 21, 2006

Terminated All recalls posted in September 2006

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-1512-06
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jul 21, 2006
Posted by the FDA
Sep 23, 2006
Recalling firm
Boston Scientific
Quantity
1,000
Product code
LOX
FDA submissions
P950020
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 description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

37 devices cleared under P950020 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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