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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 May 01, 2007
Date Posted August 26, 2008
Recall Status1 Terminated 3 on September 10, 2008
Recall Number Z-2165-2008
Recall Event ID 48607
PMA Number P860019 
Product Classification Percutaneous Catheter - Product Code LOX
Product Boston Scientific Scimed Maverick 2 Monorail" PTCA Catheter, 3.0 mm 15 mm
REF 38928-1530
Lot 9565194
Use before 2010-04

Indicated for balloon dilation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
Code Information Lot 9565194, Exp April 2010.
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
One Boston Scientific Place
Natick MA 01760
For Additional Information Contact
800-272-3737
Manufacturer Reason
for Recall		 The units within this lot may not meet thickness specifications surrounding the wire exit port wall, which may result in an air embolization if the Port Septum Wall burts.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were sent a "Boston Scientific Urgent Medical Device Recall or Correction-Immediate Action Required" letter dated May 11, 2007. The letter addressed to Risk mangers, described the issue and product. The letter requested the immediate discontinued use of and segregation of recalled product, A Reply Verification Tracking Form was requested to be completed and returned.
Quantity in Commerce 24 Units
Distribution International Distribution --- including countries of Greece, Germany, Great Britain, Spain, Sweden, Belgium, and Algeria.
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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