Boston Scientific Corporation Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
W2405148
Products Sold
W2405148
Boston Scientific Corporation is recalling Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intrav due to Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AR, CA, FL, MO, NV
Page updated: Jan 10, 2026