Boston Scientific Fort Guide Wire, Floppy Marker Wire… recallZ-1486-2009 · Boston Scientific Corporation · initiated May 12, 2009
Terminated All recalls posted in June 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1486-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- May 12, 2009
- Posted by the FDA
- Jun 24, 2009
- Recalling firm
- Boston Scientific Corporation
- Quantity
- Total of 5 boxes (5 units /box) ,
- Product code
- DQX
- FDA submissions
- K011968
- Distribution
- USA distribution: AR, MO, CA, FL, and NV.
Product description
Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.
Code information (models, lots, serial numbers)
W2405148
Other devices under the same FDA submission
2 devices cleared under K011968 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Forté™ H74934949020Lake Region Medical · Wire, Guide, Catheter2 reports
- Forté™ H74934949070Lake Region Medical · Wire, Guide, Catheter1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 52098).
- Z-1487-2009 · TerminatedBoston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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