Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Ultra2 Cutting Balloon

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Ultra2 Cutting Balloonsee related information
Date Initiated by FirmJuly 21, 2006
Date PostedSeptember 23, 2006
Recall Status1 Terminated 3 on February 03, 2007
Recall NumberZ-1512-06
Recall Event ID 35939
PMA NumberP950020 
Product Classification Cutting Ballon - Product Code LOX
ProductBoston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760.
Code Information 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.
FEI Number 3002095335
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		Lack of assurance of sterility (pre-sterilization bioburden limits exceeded)
FDA Determined
Cause 2		Other
ActionOn 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 Commerce1,000
DistributionClass 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA DatabasePMAs with Product Code = LOX
-
-