Z-2618-2025Class II

Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm...

Name: Z-2618-2025 Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm...
Creator: Boston Scientific Corporation
Published: 2025-08-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2025-08-28 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above) on 2025-08-28. FDA classified it as Class II and gives the reason as "The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2618-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-28
Posted: 2025-09-23
Recalling firm: Boston Scientific Corporation
Product: Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On August 28, 2025 URGENT MEDICAL DEVICE REMOVAL letters were sent to customers. Instructions: 1. Immediately cease further distribution or use of any remaining affected devices. Segregate the units in a secure place until they can be returned. 2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. 3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network. 4. Return affected devices.
Quantity in commerce: 156 units
Distribution: US Nationwide distribution in the states of CA, CO, GA, ID, IL, IN, MA, ME, MI, MS, NC, OH, OK, PA, SD, TN, TX, VA, WA.
Product codes and lots: Instructions for Use: 51878205; Pre-Printed Ouch: 51368417; 1. UPN (REF): M00547030 (9-12mm Below); UDI-DI: 08714729790280; Lot Numbers: 36398057; 2. UPN (REF): (1) M00547000(9-12mm Above); UDI-DI: 08714729790266; Lot Numbers: 36426495;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2618-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2618-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-10-01	2025-09-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)