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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific

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  Class 2 Device Recall Boston Scientific see related information
Date Initiated by Firm October 21, 2021
Create Date December 01, 2021
Recall Status1 Open3, Classified
Recall Number Z-0326-2022
Recall Event ID 88991
510(K)Number K130484  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi.
UPN: M00545950
Code Information Batches: 25571372, 25673064, 25836146, 26010398, 26058426, 26123197, 26175501, 26216321, 26473779, 26759413, 26784680, 26848732, 26946145, 27121592, 27340635, 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
100 Boston Scientific Way
Marlborough MA 01752-1234
For Additional Information Contact Rebecca Kinkead Rubio
763-494-1133
Manufacturer Reason
for Recall		 Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
FDA Determined
Cause 2		 Device Design
Action Boston Scientific issued Urgent Medical Device Removal Letter to US consignees via Federal Express Priority Overnight mail on October 21, 2021. Letter states reason for recall, health risk and action to take: Cease further distribution or use of any remaining product affected by this removal immediately. Verify by product lot/batch number in the product table whether any product within your inventory is affected. If so, indicate on your Reply Verification Tracking Form the quantity of units from each lot/batch that you will be returning. If you identify any product from the affected lots/batches within your inventory, please segregate the product immediately and return it to BSC in accordance with the enclosed instructions. If you are a distributor, please note that the depth of this removal is to the end user level and this notification should be forwarded to your customers. If you are a facility that has sent products to another hospital or facility within your network, please ensure that this notification is forwarded to them. Please read carefully through the removal instructions included with this notification. Your local Sales Representative can answer any questions that you may have regarding this notification.
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC CORP.
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