—#156046

Product

Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300

FDA product code: FGE — Stents, Drains And Dilators For The Biliary Ducts
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lot Number: 19343203 Exp.: 6/30/2018

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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 BSCFieldActionCenter@bsci.com.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

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

Timeline

Recall initiated: 2017-06-01
Terminated: 2018-06-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #156046. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.