Boston Scientific Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NM, NC, OH, OK, PA, SC, TN, TX, WV, WI, PR