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U.S. Department of Health and Human Services

Class 1 Device Recall 10 Fr FlexCath Select Steerable Sheath

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  Class 1 Device Recall 10 Fr FlexCath Select Steerable Sheath see related information
Date Initiated by Firm February 23, 2015
Date Posted March 17, 2015
Recall Status1 Terminated 3 on October 07, 2015
Recall Number Z-1276-2015
Recall Event ID 70644
510(K)Number K142684  
Product Classification Introducer, catheter - Product Code DYB
Product Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065.

The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
Code Information Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Management
8200 Coral Sea St NE
Saint Paul MN 55112-4391
For Additional Information Contact
763-526-6000
Manufacturer Reason
for Recall		 Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action The firm, Medtronic, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2015 to its consignees/customers. Medtronic representatives, beginning Monday, Feb 23, 2015 hand delivered the letter to US consignees/customers.. The letter was addressed to Physician, Risk Manager and Health Care Professional. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately quarantine all unused product; return all affected product to Medtronic; contact Customer Service at 1-800-848-9300 to initiate product return and to complete and return the Customer Confirmation Certificate to via email to: RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. In additions, consignees/customers should share this notification with others in your organization. Your Medtronic field representative may assist the customers with identifying suitable replacement product. If you have any questions, contact Customer Service at 1-800-848-9300.
Quantity in Commerce 151 (4 US, 147 OUS)
Distribution Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.
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 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 = DYB and Original Applicant = Medtronic CryoCath LP
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