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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 Scientificsee related information
Date Initiated by FirmFebruary 21, 2022
Create DateApril 28, 2022
Recall Status1 Terminated 3 on April 18, 2024
Recall NumberZ-1016-2022
Recall Event ID 89882
510(K)NumberK190628 
Product Classification Introducer, catheter - Product Code DYB
Product Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
Code Information Lot Numbers: PD01, PD00013140  UDI: 00850004312001
FEI Number 1000121130
Recalling Firm/
Manufacturer		 Freudenberg Medical, Llc
2301 Centennial Blvd
Jeffersonville IN 47130-8975
For Additional Information ContactSAME
812-280-2400
Manufacturer Reason
for Recall		Non-intended glue from the hub/shaft bond on the inside ID of the catheter shaft may cause Embolism leading to peripheral ischemia
FDA Determined
Cause 2		Process control
ActionBoston Scientific issued letter dated Feb 2022 -Model 8782 EMPOWER" Introducer Sheath Product Retrieval and MODULAR ATP Clinical Study Temporary Enrollment Suspension. Letter states reason, health risk and action to take: 1. Immediately segregate all affected product to ensure that it will not be used. 2. Your local Field Clinical Engineer will retrieve and return affected product and assist you in completing the enclosed Reply Verification Tracking Form. 3. Do not enroll new patients into the MODULAR ATP Clinical Study until further communication from Boston Scientific is received. 4. Continue following enrolled patients per protocol. 5. Communicate with your IRB/ EC as required by your site. BSC recognizes the impact of communications on both you and your patients. We are committed to transparent communication with healthcare professionals to ensure you have timely, relevant information for managing your patients and conduct this clinical study with the highest quality and ethical standards. If you have further questions, please contact Ken Stein, MD, Sr. Vice President and Chief Medical Officer, Boston Scientific Rhythm Management
Quantity in Commerce13 units (US)
DistributionUS distribution: GA, OH Foreign distribution: Netherlands
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 = DYB
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