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U.S. Department of Health and Human Services

Class 2 Device Recall Boston Scientific WATCHDOG Hemostasis Valve

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 Class 2 Device Recall Boston Scientific WATCHDOG Hemostasis Valvesee related information
Date Initiated by FirmApril 05, 2023
Date PostedMay 16, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1592-2023
Recall Event ID 92072
510(K)NumberK172453 
Product Classification Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass - Product Code DTL
ProductWATCHDOG Hemostasis Valve Kit, UPN H74939343A022 (outer package), UPN H74939343A020 (inner package)
Code Information GTIN 08714729996019 (outer package), GTIN 08714729965794 (inner package), Batch numbers: 30272850,30542947,30661041,30845826, 30935565
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Scimed Pl
Maple Grove MN 55311-1565
For Additional Information ContactRebecca KinKead Rubio
763-494-1133
Manufacturer Reason
for Recall		The firm received complaints of the Insertion Tool component being occluded, resulting in the inability to pass a guidewire through the tool.
FDA Determined
Cause 2		Process control
ActionBoston Scientific issued an URGENT MEDICAL DEVICE PRODUCT REMOVAL notice on 04/05/2023 by overnight mail. The notice explained the issue and the hazard and requested the consignee segregate the devices pending return. Medical facilities who distributed the devices and distributors were directed to send the notice to their customers.
Quantity in Commerce1300 units
DistributionWorldwide
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 = DTL
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