Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
FDA Recall Z-2618-2025 · Posted 2025-09-23
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Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeFGE
Date Initiated2025-08-28
Product Quantity156 units
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.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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