Z-1941-2015Class II

Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product...

Name: Z-1941-2015 Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product...
Creator: Boston Scientific Corporation
Published: 2015-04-27
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-04-27 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval... on 2015-04-27. FDA classified it as Class II and gives the reason as "One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label". 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-1941-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-27
Posted: 2015-07-01
Terminated: 2016-01-27
Recalling firm: Boston Scientific Corporation
Product: Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Boston Scientific sent an Urgent Medical Device Recall Removal letter dated April 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected product in their inventory, quarantine the affected product immediately and return to Boston Scientific in accordance with the enclosed recall instructions. Customers will receive replacements for all recalled product that is returned to Boston Scientific. Customers were instructed to forward the recall notification to their customers. Customers with questions were instructed to contact their local sales representative. For questons regarding this recall call 763-494-1133.
Quantity in commerce: 39 units
Distribution: Worldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
Product codes and lots: Lot: 17673858

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1941-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1941-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-08	2015-06-30

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)