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U.S. Department of Health and Human Services

Class 2 Device Recall Extractor Pro RX Retrieval Balloon

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 Class 2 Device Recall Extractor Pro RX Retrieval Balloonsee related information
Date Initiated by FirmAugust 28, 2025
Date PostedSeptember 23, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2618-2025
Recall Event ID 97529
510(K)NumberK102082 
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
ProductExtractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Code Information 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;
FEI Number 3005099803
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactRenee Archie
508-683-4000
Manufacturer 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 2		Process control
ActionOn 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 Commerce156 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FGE
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