Terminated

Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. 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. Made in USA.

FDA Recall Z-1541-06 · Posted 2006-09-29

Recalling FirmBoston Scientific

Recall StatusTerminated

Product CodeDQX

Date Initiated2006-08-31

Date Terminated2007-06-26

Product Quantity343 Total. 329-US, 14-Foreign

Reason for Recall

The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.

Firm Action

An Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.

Root Cause

Other

Distribution Pattern

Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countries of Austria, Belgium, Bulgaria, Chile, Columbia, Czech Republic, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Mexico, Norway, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030617PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIREBoston Scientific Scimed, Inc. · 2003-05-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.