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U.S. Department of Health and Human Services

Class 2 Device Recall Maverick 2" Monorail PTCA Catheter

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  Class 2 Device Recall Maverick 2" Monorail PTCA Catheter see related information
Date Initiated by Firm November 01, 2005
Date Posted August 26, 2008
Recall Status1 Terminated 3 on September 10, 2008
Recall Number Z-2166-2008
Recall Event ID 48608
PMA Number P860019 
Product Classification Percutaneous Catheter - Product Code LOX
Product Boston Scientific Scimed Maverick 2 Monorail 12mm Balloon Catheter, 2.5 mm x 12 mm
Made in Ireland Ballybrit Business Park, Galway, Ireland
REF 38928-1225
Use before 2007-01
UPN H7493892812250
Sterilized with ethylene oxide gas


Boston Scientific Scimed Maverick 2 Monorail 20mm Balloon Catheter, 3.5 mm x 20mm
Made in Ireland Ballybrit Business Park, Galway, Ireland
REF 38928-2035
Use before 2007-01
UPN H7493892820350
Sterilized with ethylene oxide gas

Indicated for dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Code Information Lots: 6240888, Exp January 2007; 6240363, Exp January 2007.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760
For Additional Information Contact
800-272-3737
Manufacturer Reason
for Recall		 Two lots may not be correctly labeled. Specifically , a 2.5 mm x 12 mm unit was incorrectly labeled as a 3.5 x 20 mm unit on the box and tyvek label.
FDA Determined
Cause 2		 Packaging process control
Action Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required"letter dated November 7, 2005. The letter addressed to Risk mangers, described the issue and product. The letter stated that immediate discontinued use of and segregation of the recalled product was required. A Reply Verification Tracking Form was requested to be completed and returned.
Quantity in Commerce 67 Units
Distribution International Distribution --- including countries of Czech Republic, France, Germany, Great Britain, Italy, Spain, Sweden, India, and Iran.
Total Product Life Cycle TPLC 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 Database PMAs with Product Code = LOX and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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