Boston Scientific IQ Guide Wire. Catalog No. 38950-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38950-012, 185 cm, Straight 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.
FDA Recall Z-1213-06 · Posted 2006-07-12
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Recalling FirmBoston Scientific
Recall StatusTerminated
Product CodeDQX
Date Initiated2006-05-30
Date Terminated2007-06-28
Product Quantity1455 units total
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.
Firm 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 #.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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