Extractor Pro RX recallZ-2618-2025 · Boston Scientific Corporation · initiated Aug 28, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-2618-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 28, 2025
- Posted by the FDA
- Sep 23, 2025
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 156 units
- Product code
- FGE
- FDA submissions
- K102082
- 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 description
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Code information (models, lots, serial numbers)
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;
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Extractor™ Pro RX M00547000Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall1 death76 reports
- Extractor™ Pro RX M00547030Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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