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Terminated

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

FDA Recall Z-1487-2009 · Posted 2009-06-24

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDQX
Date Initiated2009-05-12
Date Terminated2011-12-11
Product QuantityTotal of 4 boxes (5 units /box).

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K011968STREERABLE PTCA GUIDEWIRELake Region Mfg., Inc. · 2001-07-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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