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 Boston Scientific IQ Guide Marker Wire

  • 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 Boston Scientific IQ Guide Marker Wire see related information
Date Initiated by Firm May 30, 2006
Date Posted July 12, 2006
Recall Status1 Terminated 3 on June 28, 2007
Recall Number Z-1218-06
Recall Event ID 35549
Product Classification Wire, Guide, Catheter - Product Code DQX
Product Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-01J0, 185 cm, J-Tip, Single Pack. Catalog No. 38951-01J2, 185 cm, J-Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MN 01760 USA. Boston Scientific Guide Wires are steerable guide wires available in a variety of lengths and diameters. The distal tip is shapeable, or, alternatively, is available in a preshaped ''J'' tip.
Code Information Catalog No. 38951-01J0, Box Lot No. AND Inner-Pouch Lot/Batch #: 8445153/8416208, 8450266/8419531.  Catalog No. 38951-01J2, Box Lot No. AND Inner-Pouch Lot/Batch #: 8445220/8416208, 8450269/8419531.
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		 Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to the transition area of the distal end of the guide wires which may cause PTFE to flake off.
FDA Determined
Cause 2		 Other
Action On May 30, 2006, Boston Scientific notified customers of the IQ Guide Wire manufactured from February 3, 2006, through March 15, 2006. BSC requested a reply whether or not they still have product in their institution. Replacements will be issued for returned product. UPDATE: A second recall notification was sent to affected customers 07/07/06. This second notification included Inner Pouch Number (UPN) and Inner Pouch Lot/Batch #.
Quantity in Commerce 1455 units total
Distribution Nationwide (AR, AZ, FL, GA, IA, ID, IL, IN, KY, LA, MA, MI, MN, MO, NC, NH, NJ, NM, NV, OH, OK, PA, TN, TX, UT, VA, WI, WV) and Puerto Rico. Chile, Germany, Taiwan.
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.
-
-