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Terminated

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340

FDA Recall Z-2674-2017 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2017-06-01
Date Terminated2018-06-26
Product Quantity32 units

Reason for Recall

Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

Firm Action

Boston Scientific Notifications to US consignees sent via Federal Express Priority mail on June 1, 2017. The notification instructs the account to check inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact: Brendan Smith, Boston Scientific Quality Systems, 763-494-1133 [email protected].

Root Cause

Employee error

Distribution Pattern

MI, MO Foreign: Austria France Great Britain Italy Spain Sweden

Official Source

View FDA Recall →

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

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