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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Extractor Pro XL Retrieval Balloon Catheter

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 Class 2 Device Recall Boston Scientific Extractor Pro XL Retrieval Balloon Cathetersee related information
Date Initiated by FirmDecember 18, 2013
Date PostedJanuary 10, 2014
Recall Status1 Terminated 3 on August 19, 2014
Recall NumberZ-0710-2014
Recall Event ID 67139
510(K)NumberK102082 
Product Classification Catheter, biliary, diagnostic - Product Code FGE
ProductBoston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above UPN: M00547100 The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the biliary system; or 2) to facilitate injection of contrast medium while occluding the duct with the balloon.
Code Information Lot Number:16231178 
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact
508-382-9555
Manufacturer Reason
for Recall		Extractor Pro XL Retrieval Balloon Catheters may have the incorrect skive hole location or balloon size
FDA Determined
Cause 2		Process control
ActionBoston Scientific issued an Urgent Medical Device Recall Removal letter dated December 18, 2013, to all affected customers via Federal Express Priority mail.3. The notification instructs the account to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. For questions regarding this recall call 508-382-9555.
Quantity in Commerce39 units
DistributionWorldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
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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