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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 1215 mm

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  Class 2 Device Recall Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 1215 mm see related information
Date Initiated by Firm December 18, 2013
Date Posted January 10, 2014
Recall Status1 Terminated 3 on August 19, 2014
Recall Number Z-0712-2014
Recall Event ID 67139
510(K)Number K102082  
Product Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm
Injects Below
UPN :M00547140
Code Information Lot Number: 16230354
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
Action Boston 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 Commerce 34 units
Distribution Worldwide Distribution - USA (Nationwide Distribution and Puerto Rico) and Internationally.
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) Database 510(K)s with Product Code = and Original Applicant = BOSTON SCIENTIFIC CORP.
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