Boston Scientific Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38951-012, 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38951-012, 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.
Brand
Boston Scientific
Lot Codes / Batch Numbers
Catalog No. 38951-010, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423358/8387074, 8453483/8432572, 8464007/8432571, 8510637/8404526. Catalog No. 38951-012, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423360/8387074, 84640088432571, 8510638/8404526.
Products Sold
Catalog No. 38951-010, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423358/8387074, 8453483/8432572, 8464007/8432571, 8510637/8404526. Catalog No. 38951-012, Box Lot No. AND Inner-Pouch Lot/Batch #: 8423360/8387074, 84640088432571, 8510638/8404526.
Boston Scientific is recalling Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. due to Boston Scientific discovered through an internal inspection process that the PTFE (polytetrafluoroethylene) coating is not consistently adhering to th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 #.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026