Z-0711-2014Class II

Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110

Name: Z-0711-2014 Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Creator: Boston Scientific Corporation
Published: 2013-12-18
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2013-12-18 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110 on 2013-12-18. FDA classified it as Class II and gives the reason as "Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0711-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-18
Posted: 2014-01-10
Terminated: 2014-08-19
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above UPN: M00547110
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 38 units
Distribution: Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
Product codes and lots: Lot Number: 16231174

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0711-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0710-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10
Z-0711-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10
Z-0712-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-10

Product code FGE

K102082Class IIExtractor Pro Rx Retrieval Ballons, Extractor Pro Xl Retrieval Ballons, Extractor Pro Dl Retrieval Ballons Model M005470Boston Scientific Corp / cleared 2010-08-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)