Recall Z-1538-06 ยท DQX Wire, Guide, Catheter
Boston Scientific
Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. 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.
| Date | Sep 29, 2006 (initiated Aug 31, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 1,423 total. 168-US, 1,255-foreign |
| Distribution | 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, Finla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE Boston Scientific Scimed, Inc., May 21, 2003 |