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U.S. Department of Health and Human Services

Class 2 Device Recall TwinPass Dual Access Catheter

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 Class 2 Recall
TwinPass Dual Access Catheter
see related information
Date Posted August 21, 2009
Recall Status1 Open
Recall Number Z-1712-2009
Recall Event ID 52633
Premarket Notification
510(K) Number
K060327 
Product Classification Catheter, Percutaneous - Product Code DQY
Product Twin-Pass® Dual Access Catheter , REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic, Manufactured by Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369. The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents.
Code Information Lot Numbers: 540787, 540909, 541079, 541304, 541342, 541881, 541992, 542111, 542253, 542302, 542693, 542875, 542962, 542994, 543173, 543304, 543508, 543590, 543591, 543698, 543775, 543922, 544188, 544315, 544597 and 544831.
Recalling Firm/
Manufacturer
Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove, Minnesota 55369-6032
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Three occurrences of Twin-Pass¿ catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Vascular Solutions, Inc. issued an "Urgent: Medical Device Recall - Lot Specific" notice dated July 6, 2009. The letter described the problem and product involved and asked Consignees to immediately check their Twin-Pass® catheter inventory, remove any affected units and complete the Product Recall Inventory Form and return to Customer Service Department. For further questions, contact Vascular Solutions, Inc. at 1-763-656-4300.
Quantity in Commerce 5885
Distribution Worldwide Distribution -- Including Puerto Rico and states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and DC and countries of CANADA, SPAIN, GREECE, IRELAND, NORWAY, SWITZERLAND, ENGLAND, TURKEY, ISRAEL, GERMANY, AUSTRIA, TAIWAN, FINLAND, SWEDEN, FRANCE, IRELAND and PORTUGAL.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQY and Original Applicant = VASCULAR SOLUTIONS, INC.
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