—#82091

Product

Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures.

FDA product code: DQX — Wire, Guide, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K011968
Affected lot / code info: 01403876

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: USA distribution: AR, MO, CA, FL, and NV.

Timeline

Recall initiated: 2009-05-12
Posted by FDA: 2009-06-24
Terminated: 2011-12-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #82091. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.