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.
This recall has been terminated (originally issued August 21, 2009).
- Company
- Vascular Solutions, Inc.
- Recall Initiated
- July 2, 2009
- Posted
- August 21, 2009
- Terminated
- April 3, 2012
- Recall Number
- Z-1712-2009
- Quantity
- 5885
- Firm Location
- Maple Grove, MN
- Official Source
- View on FDA website ↗
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
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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
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.