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U.S. Department of Health and Human Services

Class 2 Device Recall Extractor Pro RX

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 Class 2 Device Recall Extractor Pro RXsee related information
Date Initiated by FirmApril 27, 2015
Date PostedJuly 01, 2015
Recall Status1 Terminated 3 on January 27, 2016
Recall NumberZ-1941-2015
Recall Event ID 71137
510(K)NumberK102082 
Product Classification Catheter, biliary, diagnostic - Product Code FGE
ProductExtractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000 The Extractor Pro RX Retrieval Balloon Catheters are intended for use endoscopically to remove stones from the biliary system, or to facilitate injection of contrast medium while occluding the duct with the balloon.
Code Information Lot: 17673858
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information ContactBrendan Smith
763-494-1133
Manufacturer Reason
for Recall		One lot of the Extractor" Pro RX Retrieval Balloon Catheter (9-12mm balloon) contains an incorrect syringe size (12-15mm), which is larger than the size identified on the label.
FDA Determined
Cause 2		Employee error
ActionBoston Scientific sent an Urgent Medical Device Recall Removal letter dated April 27, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected product in their inventory, quarantine the affected product immediately and return to Boston Scientific in accordance with the enclosed recall instructions. Customers will receive replacements for all recalled product that is returned to Boston Scientific. Customers were instructed to forward the recall notification to their customers. Customers with questions were instructed to contact their local sales representative. For questons regarding this recall call 763-494-1133.
Quantity in Commerce39 units
DistributionWorldwide Distribution including the following countries: France, Great Britain, Spain, Ireland. .
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FGE
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