Recall Z-2618-2025
Boston Scientific Corporation · initiated August 28, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Codes / 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;
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.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2618-2025
- Initiated
- August 28, 2025
- Posted by FDA
- September 23, 2025
- Product code
- FGE – Stents, Drains And Dilators For The Biliary Ducts
- 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.
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA