Recall Z-1486-2009 ยท DQX Wire, Guide, Catheter
Boston Scientific Corporation
Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.
| Date | Jun 24, 2009 (initiated May 12, 2009) |
| Status | Terminated |
| Reason | Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the |
| Root cause | Process control |
| Action | Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated may 19, 2009. The letter was addressed to "Dear Risk Manger/ Field Action Contact". The letter described the problem, customer steps for recall and listing of product batches / lots. The letter requested consignees to return the Reply Verification Tracking Form. |
| Quantity | Total of 5 boxes (5 units /box) , |
| Distribution | USA distribution: AR, MO, CA, FL, and NV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011968 | STREERABLE PTCA GUIDEWIRE Lake Region Mfg., Inc., Jul 25, 2001 |