Recall Z-2618-2025 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Boston Scientific Corporation
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
| Date | Sep 23, 2025 (initiated Aug 28, 2025) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K102082 | EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 Boston Scientific Corp, Aug 23, 2010 |