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Terminated

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.

FDA Recall Z-0710-2014 · Posted 2014-01-10

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFGE
Date Initiated2013-12-18
Date Terminated2014-08-19
Product Quantity39 units

Reason for Recall

Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size

Firm Action

Boston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account to check their 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. For questions regarding this recall call 508-382-9555.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102082EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470Boston Scientific Corp · 2010-08-23

Official Source

View FDA Recall →

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

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